Episode #91 | 3D Printed Pharmaceuticals (Virtual Event Recording) - The Lattice (Official 3DHEALS Podcast)

Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Speaker 1 (00:05):
Hello, hello, good morning.
It's me again, jenny Chen,founder CEO of 3D Heals.
We've been doing this webinarseries for quite a few years now
.
3d Heals as a company has threemission.
One is to educate the publicabout what 3D printing and 3D
technology can do for healthcare, and today is one example of

(00:26):
that.
And number two mission is tocreate an environment for
networking.
We haven't hosted a lot ofin-person events since the
pandemic, but we hope to restartand we have hosted a few, so
stay tuned in our newsletters ifyou want to join some of that.
But virtual events can beeffective also.

(00:49):
One is you can learn, probablyfocus better and you can see the
slides better without squinkingyour eyes.
Number two is you can put yoursocial media information in the
chat box, or just chat, whateverthe chat box is for socializing
, so you can tell people who youare, what you're looking for.
However, the only thing youshouldn't put in your chat box

(01:12):
is questions, because I cannotkeep track of your question if
you don't put them in a QA box.
So make sure you put them in aQA box.
Okay, so that our number twomission.
Number three is we have aprogram called pitch 3d.
We focus on helping early stagestartup in this space.
So 3d technology in healthcare,with fundraising and there's no

(01:35):
fee associated with itwhatsoever, as long as you
qualify, and we introduce ourstartups to a group of
institutional investors on aregular basis, and so reach out
to me if you're interested.
All right, let's talk about thetopic today.
Today's topic.
We have been presenting thistopic for a number of years.

(01:57):
I'm investing in one of thestartups here, craft Health, and
I am very passionate about thisspace because, as a doctor, I
know how dangerous polypills canbe for elderlies and just in
general, like why would you wantto take a dozen of large pills
when you can combine them intoone?
So the idea sounds reallyattractive to create

(02:20):
personalized pill that's moreeasily ingested and more
effective.
But where we are?
Because the concept soundsamazing, but implementing,
commercializing it, is anotherstory.
So we have a group of experts,a really phenomenal panel of
pioneers in the field and peoplewho really will make a dent in

(02:43):
the future of 3D printedpharmaceuticals and
nutraceuticals today.
So I'm really happy we havethis great group of people and I
had a quick glance of ouraudience list and hopefully
quite a few people that I knoware going to join the live
audience.
I know they're also veryknowledgeable in the space, so
it's going to be an amazingconversation.
Without further ado, I'd liketo introduce our first speaker,

(03:06):
dr Averil Goianes.
He is the CEO and co-founder ofFabRx, which is considered one
of the first companies in thespace of 3D printed drugs.
Averil, you are on.
Maybe you can unmute yourselfand start presenting perfect,

(03:28):
great.
Thank you and everyone else canbe off screen and mute
themselves.

Speaker 2 (03:31):
Thank you so much thank you for the introduction
and thank you for theopportunity to present here.
I'm going to share my screen,whole screen, so hopefully you
are going to see my presentationfull screen.
Now, correct, yeah?

(03:54):
So yeah, the company Fabrics.
I'm the CEO and co-founder ofFabrics.
Fabrics is a spin-out companyfrom UCL University College
London.
We are based in London, but wehave a subsidiary company in
Spain, in Europe, that isFabrics AI, more focused on the

(04:15):
use of artificial intelligencefor the development of medicines
, the dose prediction,everything related to 3D
printing.
And we have also fabrics in theUS for our customers in the US.
I'm going to talk about 3Dprinting in hospitals and
pharmacies and how fabrics.
What is our vision in fabrics?

(04:35):
So, the benefits ofpharmaceutical 3D printing when
we are talking aboutpharmaceutical 3D printing, we
are talking about a layer bylayer process, additive
manufacturing, and in thisprocess, thanks to this process,
we can print formulations likeoral dosage forms.

(04:56):
We can print implantabledevices that we can insert in
the body and release drug duringmonths or weeks, and I'm going
to focus mainly in oralformulations.
What is the advantages of using3D printing for oral
formulations?
We can automate compounding,make medicines more personalized
in terms of doses, flavors,colors, shapes.

(05:18):
We can make medicines saferbecause we have different
quality control methods insidethe printers we are printing in
hospitals and pharm controlmethods inside the printers we
are printing in hospitals andpharmacies, closer to the
patient.
So we are more environmentallyfriendly, reducing carbon
footprint, reducing the stock ofmedicines with different doses
and, thanks to 3D printing, wecan have faster and cheaper

(05:41):
clinical trials for thedevelopment of new medicines
faster and cheaper clinicaltrials for the development of
new medicines.
So how we started?
We started in 2014.
I was a researcher.
I have two hats my academic hatwith the University College
London, I'm an honorary lecturerthere and I'm also a professor
in the University of Santiago deCompostela in Spain.

(06:01):
So I do a lot of research and Ialso have my business hat, that
is with fabrics.
So in 2014, when we starteddoing research about 3D printing
, we were saying we are going toprint medicines in hospitals
and pharmacies.
Everybody was laughing becausethey thought it would be
impossible.
So in 2018, we did the firstclinical study where we print

(06:26):
medicines with a 3D printer in ahospital and we print chewable
tablets for patients pediatricpatients with a rare metabolic
disease.
This was a groundbreaking studybecause we proved that 3D
printing could be implemented inhospital.
Thanks to this study, we got agrant to develop the first
pharmaceutical 3D printer,launching to the market in 2020.

(06:50):
It's the MediMaker.
And since then we have donemore clinical studies.
We printed medicines combiningtwo different drugs, so drugs
combinations with high dose,also for rare metabolic diseases
.
Since then, we were the firstusing a 3D printer in a pharmacy

(07:12):
, in a normal pharmacy,community pharmacy, and we
published the first article witha 3D printer implementation in
a community pharmacy.
Since then, we have been doingmultiple clinical collaborations
, partnerships with the besthospitals in the world,
pharmaceutical companies.
We are involved in more than 30clinical trials all around the

(07:36):
world.
And also we were contacted byNASA because in our vision and
one of the articles we published, we publish more than 110
articles.
One of the articles we publishthe title is To Infinity and
Beyond Strategies to MakeMedicines in Outer Space.
We grabbed attention of NASAand we were visiting Cape

(08:01):
Canaveral Kennedy Space Center.
The chief medical officer fromNASA, jd Polk, gave us a tour
there.
How can we implement 3Dprinting in space, in different
planets?
Because 3D printing isdefinitely the future.
So when we are talking about 3Dprinting, we are talking about

(08:24):
layer-by.
We are talking about layer bylayer process.
If it's not layer by layerprocess, it's not 3D printing,
it's something else.
But with our 3D printerssometimes we find partners or
customers that tell us well, 3dprinter sometimes takes time, we
want something faster.
So with our 3D printers we areable to print inside blisters,

(08:46):
so do blister filling, and toprint inside capsules.
It's the same 3D printer usingmore or less similar materials
but under different conditions.
So blister filling and capsulefilling is faster because we are
not worried about the shape.
But obviously it's not 3Dprinting, although we use a 3D
printer.
In one of the studies in apharmacy it was very interesting

(09:12):
because we proved that with a3D printing we can reduce manual
labor, reduce production costper medicine and we were able to
produce thousands of tabletsper day.
In the video you can see how theprocess is.
You select a pharma ink, youscan it, you put it in the

(09:33):
printer, you select the dosesthat you want to print.
It prints directly into theblisters.
The balance under the blisteris recording the weight of each
individual formulation.
Then you close the blister andyou give it to the patient.
So this is also safer for thepharmacist because there is no
high exposure to the medicinesfor the pharmacist.

(09:57):
How is the process?
Well, if we cannot buy a pharmaink, we need to wait excipients
and drugs, following a SOP, aprotocol that is in the software
.
We put that in a syringe.
We melt all the materials inthe syringe, then we select the
syringe, we put it inside theprinter, we select what we are
going to do 3D printing, capsulefilling, blister filling.

(10:17):
The doses that we are going toprint, we need to enter our code
and then we print.
We print and record the dosesat the same time.
Here is with a capsule fillingminoxidil formulations.
That is a study that we did ina pharmacy and we can see how
the weights are recorded and howwe can get a report with the

(10:38):
weight of all the formulationsthat can be stored.
So this is conventionalclinical practice.
It's not science fiction.
It's something that can beintegrated in a pharmacy right
now and we have printers inseveral pharmacies in different
countries Europe, us.
So how we work we offer thepharmacists the opportunity to

(11:01):
select many different materialsfrom many different providers.
We don't ask the pharmacist tobuy materials from us.
Why?
Because we are in Spain or inLondon or we are in one state in
the US, but maybe the bestmaterial arrives faster from a
company like Specialized Rx orPCCA or Medisca or Meta

(11:22):
Pharmaceuticals.
So you select the materials youwant to use.
You put them in a containerfrom GACO or a waiter container.
You mix everything, put it in asyringe, put it inside the
printer and print.
We have different qualitycontrol methods.
The most important one is thebalance, because you know the
weight of each individual tablet.

(11:43):
We have a pressure sensor thatidentifies when we are extruding
if there is any problem.
So the pressure diagram shouldbe always the same.
If it's not the same, we knowthere is a problem with the
formulation.
And additionally, we can addNIR, near infrared to know the
concentration of drug inside theformulation.

(12:03):
Nir is more research-orientedand it doesn't work with all the
drugs, but with many drugs NIRcan be used.
So the software is key becauseyou need to have all the
libraries, the protocollibraries.
There you can share protocolswith other pharmacies.
It identifies the QR codes andbarcodes from the syringes, the

(12:25):
blisters, the base, and hasautomatic audit record so you
can keep everything in thesoftware.
We have many partnerships withcompounding suppliers so you can
buy materials from them.
We have collaborations withpharmacies, obviously because

(12:46):
they implement this to treatpatients.
We have collaborations withuniversities, research
institutions, pharmaceuticalcompanies like Pfizer.
We published recently anarticle where, with the team at
Pfizer, we were using 3Dprinting for clinical studies,
first in human clinical studies.

(13:07):
We have more collaborationswith other pharma companies that
we cannot disclose.
Some of them are for oralformulations, some of them are
for implantable formulations.
That I'm not talking that muchhere because I think the focus
is more oral Partnerships.
Collaborations with the Centerfor Disease Control, us
Pharmacopeia.
We are taking part indiscussions with the FDA

(13:29):
European Agency QualityInnovation Group For us
regulation is key and we havepartnerships with many hospitals
around the world, so I cannotinclude all of them here.
I would like to highlight GustavRussi.
It's the biggest hospital forcancer research in Europe and I

(13:49):
think it's the leading hospitalin the implementation of 3D
printing.
They have two of our Medimaker2 that has multiple printheads
so they can do drug combination,anti-cancer drug, pediatric
medicine for cancer treatments,anti-cancer drug, pediatric
medicine for cancer treatments,taste masking.
So what they do is at theforefront of research and

(14:12):
implementation in the worldright now.
We have partnerships all aroundthe world.
We have printers in India,china, japan, saudi Arabia,
europe, brazil, many differentcountries, even Africa as well.
So what we want is tocollaborate with everyone to
implement and move our dreamthat started in a small lab in

(14:36):
UCL all over the world and make3D printing a reality.
That we think is a realityright now, but we are very happy
to work and have partnershipswith everyone.
So, as a company, what we offeris the printer, the Medimaker,
state-of-the-art technology withbalance pressure sensor, nir.

(14:56):
We have the software to controlthe printer.
We don't want the pharmacist toknow anything about 3D modeling
, 3d design, just select thedose and print.
And we developed PharmaInk.
Pharmaink is a mixture of drugand excipients Excipients
whatever excipients you want touse, conventional pharmaceutical
excipients and any drug.

(15:16):
We were printing many differenttypes of drugs.
So when I was invited to thisconference, I wanted a list of
things that we need to considerwhen we are talking about 3D
printing.
One of them is a type ofmedicines that we want to design
for the patients If we aretalking about chewable tablets,

(15:38):
oral dispersible tablets, films,capsules, strokes,
suppositories.
So is the printer able to doall of that?
Our technology is Acceptabilityof the medicines.
We need to ask patients whatthey want.
Obviously we need to make themattractive to the patients not
too attractive to children, butattractive to the patients and

(16:00):
for that we need to do clinicalstudies and ask patients what
they want, what they prefer, andthis is what we do.
Selection of drugs which drugsare the most beneficial for the
technology?
We were printing many differenttypes of drugs.
I think we have a library withmore than 150 drugs.
We printed antibodies, smallpeptides, crazy drugs.

(16:25):
Many of them we cannot disclosebecause they are in
collaboration with pharmacompanies.
But it's critical to select theright drug.
Are we able to print the drug inthe range of doses?
That is the correct one,because maybe we can print the
drug at 5 milligrams or 10milligrams.
That's very easy, but manytimes the difficult part is to

(16:49):
print in the whole range.
That's why 3D printing is veryimportant.
We were able to print medicineswith drugs at 1.2 grams, so
1200 milligrams, and it's veryhigh.
For that you need 3D printing,something that is layer by layer
With filling, although it'sfaster, you cannot reach

(17:11):
sometimes this high drug loading, maybe 500 milligrams but are
you able, with your technology,to reach the therapeutic drug
level?
This is critical because maybeyou print with one drug but you
don't reach the therapeuticlevel and you need the whole
range, maybe from fivemilligrams to 500 milligrams.
Is the technology able to dothat?
Yeah, published dataformulations are openly

(17:39):
disclosed to have clearunderstanding of what the
excipients you are using thepharmaceutical excipients that
you can get from an approvedprovider in your country.
And we published all the data,or most of the data, only data
that is confidential we cannotpublish.
We evaluated all the 3Dprinting technologies FDM,

(18:00):
semi-solid extrusion, sls, slaall of them.
Fdm, semisolid extrusion, sls,sla all of them and we selected
the ones that we think are thebest for this.
That are material extrusion,semisolid extrusion, fdm that
uses filament for implantables,and direct powder extrusion that
use a powder.
And then regulatory approval.

(18:21):
At the beginning, we startedwith a food printer.
It was a disaster.
You need a pharma printer thatworks and is especially designed
to print medicines.
It's very important.
The certificate of the syringesbecause they are in contact
with the drug are syringes thatare certified.

(18:43):
Our syringes are easy to usebecause if they are not easy to
use, users are not going to usethe technology and easy to clean
, so validated cleaningprotocols are very important.
It's important to consider whatthe formulations are going to be
, if they are going to needrefrigeration or not.
If you need to keep them in afridge, maybe it's not so

(19:05):
attractive for patients.
So ideally, you want yourformulations to be water-free.
The one that you see in thevideo looks like liquid, but
it's not a liquid.
It's based on polyethyleneglycol that melts at 60 degrees
but then solidifies immediately,so it's water-free, and the
stability of these formulationsis very long so more than six

(19:25):
months and it's important if youare going to use this
technology for clinical studiesor for a standard clinical
practice, you need to have thisversatility.
So this is my presentation.
We have a lot of webinars inour webpage, so if you go to
fabricscouk webinars, we havemore information and you can

(19:47):
send me emails and I'm happy todiscuss potential collaborations
.
That's all, thank you.

Speaker 1 (19:55):
Thank you.
I cannot believe you guyspublished what 100, more than
100 papers.

Speaker 3 (20:00):
Yes.

Speaker 2 (20:01):
That's crazy.
Yeah, we are very productive.

Speaker 1 (20:06):
Okay, well, that's a very comprehensive, excellent
presentation.
I learned so much.
Every time I see yourpresentation, I thought I
already knew everything, but no,you always have something new.
Can you tell us some of thelimitations that you're
experiencing right now with yourcurrent system and what are you
working on in terms ofchallenges?

(20:27):
I think you're muted somehow, Idon't know why, sorry.

Speaker 2 (20:29):
I don't think there are technical limitations.
I think there are limitations.
The main limitation ofimplementing 3D printing is
awareness.
Many people see this technologylike a far technology,
futuristic technology, so forumslike this are important to show
people that this can beimplemented.

(20:51):
We are in many hospitals, manypharmacies and this is there.
So one of the limitations isprobably lack of awareness and,
obviously, people using printers.
They never study 3d printing intheir pharmacy degrees or
things like that, so we need tocreate a specific programs for

(21:13):
that.
I'm also the the chair of thepharmaceutical 3d printing
initiative that this initiativethat wants to bring together
people from academia, industry,regulation to actually implement
this technology.
So we are not just a companytrying to make money.
We actually want to change theworld and implement this
technology.
So that's why we need to cometogether to push this.

Speaker 1 (21:38):
Yeah, I love that vision.
Yeah, same here.
Now another question is of allthe cases that you can actually
share with us because I knowsome are preparatory, but the
ones that you can share, whichone is the most impactful and
promising that you have seen sofar?

Speaker 2 (21:52):
so one.
I mean we have many.
Uh, the ones that gustav russi,they are doing are for me the
best ones, because even for me,when they tell, me that's the
cancer institute right exactlygustav russi is the hospital in
france.
They tell me that's the CancerInstitute, right, yeah, exactly,
gustave Roussi is the hospitalin France.
They tell me oh, we are doingthis, for example, printing one
drug that is for cancer, totreat breast cancer, in pensions

(22:16):
with one of the two drugs toavoid the side effects of this
medication altogether.
So they are printing that andfor me that's crazy because they
are doing drug are printingthat, and for me that's crazy
because they are doing drugcombinations straight away.
And I was telling them well, gostep by step, one drug at a
time, slow, no, they were likefull on developing formulations.

(22:37):
Then we have a partnership witha company doing implants for
anti-cancer drugs as well, soremoving tumors and putting
plants with anti-cancer drug soit's not just oral medication
anymore no, no, no.
We we have a some crazy projectscrazy in terms of crazy
projects.

Speaker 1 (22:56):
Yeah, I thought I heard it wrong.
I was like no, it's actually.
He said crazy, okay, yeah, yeahit's a.

Speaker 2 (23:03):
I mean crazy, because it's like shocking innovative.
When I translate from Spanish,the word for me is crazy, but
maybe in English it's not theright word, but it's really
exciting projects, yeah.

Speaker 1 (23:18):
Okay, great, thank you so much.
Okay, we have a couple ofquestions from the audience.
One is from Shubhansi much okay.
We have a couple questions fromthe audience.
Um, one is, uh, from a shoeband scene.
I'm preparing 3d printedtablets.
How we select free ability andhardness parameters?
Okay, so, mechanical properties.
Parameters for print.

Speaker 2 (23:37):
Yeah, so friability and hardness, or breaking force,
are some parameters that,according to the pharmacopoeia,
are probably more focused ontraditional tablets.
For example, if you areprinting directly into a blister
, you don't need to dofriability and hardness.
Why?
Because normally you are goingto remove it from the blister

(23:58):
and take it.
So these parameters are usefulfor when you are in an industry
and the tablets are going to bein big drums and then you need
to pack them.

Speaker 1 (24:09):
So yeah, so there you go.
That's the 3D printingeducation Exactly.

Speaker 2 (24:14):
There are no specific requirements for these tablets.
So you can do the standardmethod and say like well, the
relevance of these results iswhat it is.
Okay, another question fromLuciano Vragio uh, sterile,

(24:39):
sterile, sterility, um yeah, howdo you keep them sterilized?
Basically, yeah.
So, uh, for example, forimplantable devices, uh, what we
have is we have the printers infume hoods or in hoods that are
inside GMP clean rooms.
So we sterilize the printerfrom outside, but most of the
time for implantable device, yousterilize the product after
production.
This is the standard practiceas well For oral formulations.

(25:03):
You are not aiming for sterileformulations, they are just oral
formulations.
You can have them in GMP areas,especially for clinical studies
, but sterility is not arequirement.
But for medical devicesdrug-loaded medical devices, yes
, but normally the process isthat you do a sterilization

(25:26):
after you print.

Speaker 1 (25:27):
Okay, and then you mentioned sterilization of the
syringes.
What's the process for that?

Speaker 2 (25:35):
What is important is that the syringes that you use
are approved to be in contactwith drugs at these temperatures
, that there are no productsthat go into the formulation and
that the materials don'tinteract with the syringes,
because the syringes are intouch with the drug and you are
going to swallow theseformulations.

Speaker 1 (25:55):
That's what is important okay, let me see I
have another question.
Uh, we have a lot morequestions.
You may have to type in theanswer because, um, I want to
keep us in the same pace.
So let's just pick one more.
Let's see Wow, it just keepscoming here.
Let's see Okay, so from Jack, Irun a pharmacy business For

(26:21):
scale-up how much material, bothAPI and and excipients, can you
support every month inkilograms?
It sounds like something else,but no, it's not.
But that's a good question.

Speaker 2 (26:32):
Okay, this is a very practical question so yeah, it
depends on the use you give tothe printer.
In some pharmacies they use theprinter one or two days like
full and then they don't use itthe rest of the week.
So during these two days theyprepare 8,000 or 10,000
formulations per day.

(26:53):
I don't know what is the bulkmaterial.
I know they have big drums ofmaterials like three kilograms
and things like that, but theyuse it for two, three days.
Other pharmacies they printevery day some formulations.
It depends on the state, I meanthe country.
So in the US it's possible toget some batches.

(27:15):
In other countries in Europeyou need to make the batch just
for the patient.
It depends on the regulation.

Speaker 1 (27:22):
Yeah, you do not provide the materials, you just
provide the system to make themedication.

Speaker 2 (27:27):
We provide the system , the know-how, the materials.
We recommend them to buy thematerials from local providers.
We recommend some materials, wegive the protocols, but we
don't sell the materials.
If they don't find thematerials, for whatever reason,
we can't provide the materials,but our business is not selling

(27:48):
materials, great.
We are a company doing AIhardware software, not selling
materials.

Speaker 1 (27:55):
Yes, you're the first company I heard in the space
actually use machine learning,even before the hype of AI.
So good, first starter.
So we have quite a fewquestions, but I don't think I'm
gonna address all of them justbecause of time.
You can feel free to type in theanswer.
And also, guys, if you wantyour question to be a priority,
just type them in while thespeaker is still talking, so

(28:18):
that I can get them in.
All right, thank you so much,professor.
I'm gonna introduce our nextspeaker, okay, okay, our next
speaker is Dr Sing Han Lin,another doctor.
We have all the doctors heretoday.
He is the CTO and co-founder ofCraft Health, a company in

(28:41):
Singapore also working on 3Dprinted drugs all right, hello
everyone.

Speaker 3 (28:55):
Thank you to jenny and, of course, 3d hues for the
kind invitation and, of course,for this uh, excellent platform
itself that allows us to reallyhave this wonderful discussion
with some of the world's leading3d printing pharmaceutical
company.
So, without further ado, let meactually just share my screen.
I think everyone is able to see.
So, really, the title of mydiscussion today is really about
3D printed pharmaceuticals andhow is it an avenue towards

(29:15):
personalized medicine.
At the same time, I'll alsodiscuss some of the key barriers
that we believe is actually keybarriers to mass adoption of 3D
printing in terms ofpersonalized medicine, and how
we believe that our craft healthplatform technology itself is
an enabler to the adoption of 3Dprinting.
Alright, so a little bit moreintroduction to myself.

(29:39):
I'm a pharmacist by training,so I practiced for a few years
in a local general hospitalthat's a Singapore general
hospital.
Subsequently, I went on to domy post-grad studies whereas
that is when I actually pickedup some of the skill set.
My thesis was basically on 3Dprinting for personalized joint
delivery and testing systems.
So fast forward, about 10 yearslater now I am the co-founder

(30:00):
and the CTO COO of actuallyCraftHealth, where we are based
in Singapore.
Other relevant experiencesreally is due to the work that I
do.
I am a technical member of theSingapore Standards Council that
looks at the review of some ofthe additive
manufacturing-related standards.
Now, really, the mass-producedpharmaceuticals they have been
around for many, many years andeveryone is so used to actually

(30:22):
consuming them.
However, definitely I thinkthere are some issues with the
clinical use of thesemass-produced pharmaceuticals,
especially for specialized orspecial populations such as the
elderly or the pediatrics.
The need for customized dosing,such as for pediatrics with
dosing by weight, is sometimesnot available in a lot of these
mass-produced pharmaceuticals,and every one of us will have

(30:44):
consumed such medications before, and sometimes the doctor will
ask you to break the tablet intohalf, break the tablet into
quarter, and all these arereally not that accurate.
Polypharmacy and complexmedication schedule would often
also result in maybenon-compliance and undesirable
efficacy itself.
So that's something that isalso a clinical concern for
mass-produced pharmaceuticals.

(31:06):
Unavailability of finishedproducts meaning, for example,
like Singapore, with such asmall market size as compared to
the US, there are a lot ofproducts, a lot of finished
products, meaning, for example,like Singapore, with such a
small market size as compared tothe US, there are a lot of
products, a lot of finishedproducts that do not reach us,
that do not register in suchmarkets like Singapore.
So therefore, what is theclinical use of such finished
products, where they are notavailable, actually available in

(31:27):
a small market like Singapore?
And definitely some of thedosage forms that we have now
are also not that suitable forswallowing, and I think this is
also some concern that we shouldaddress as well.
So, with all these clinical useand clinical concerns, I think
there's really opportunities forinnovation or even
personalization of the differentdosage forms.
Number one would be reallyon-demand tablets with

(31:49):
personalized dosing.
There's also opportunity forinnovation in terms of
personalized polypill withdifferent release profiles to
help reduce the pill burden,on-demand compounding for
actually non-registered finishedproducts and definitely also
the innovative andpatient-centric dosage forms
that help patients withswallowing difficulties.
And really could 3D printing bea solution for all these

(32:11):
different opportunities andinnovation?
So the key advantages for 3Dprinting in pharmaceutical is
really the ability to actuallyhave complex geometry itself.
3d printing can easily dothings like a core and a shell
that actually encapsulate aroundto do either taste, mark, scan
or control release profiles.
Other than complex geometry, 3dprinting also allows rapid

(32:34):
prototyping and ease of usage,so definitely something that is
really useful for R&D or evenfor university for research kind
of work.
For 3D printing inpharmaceutical Personalization
could also be one of the keyadvantages of 3D printing.
That's probably also related tothe cost efficiency for small
quantities production using 3Dprinting.
That's probably also related tothe cost efficiency for small
quantities production using 3Dprinting itself.

(32:57):
Some of you may have seen thisbefore.
If you are looking attraditional manufacturing or
traditional tablet press itself,the more units of the same kind
of tablets that you produce,really the cost per unit itself
drops drastically from here allthe way down.
Then it's not so much of thecase for 3D printing because
really 3D printing there's nomold involved.

(33:17):
So conversely, there's no highupfront capital cost itself in
terms of investing the most andso on.
However, as you scale up to alarge number, you realize that
3D printing, the cost per unititself probably remains the same
.
Now, if you're willing tocross-intersect this to a graph
itself, you realize that thereis actually a very, very good

(33:38):
area of opportunity, which isthe high-value niche
personalized healthcare itselfwhere 3D printing could really
shine.
Now this sounds like ano-brainer for actually 3D
printing itself to be involvedin such personalized healthcare
or personalized medicationitself.
However, the reality is that weare not seeing 3D printing being
picked up as rapidly or asprevalently as we would want

(34:01):
around the world itself.
And then we wonder to ourselveswhat are some of the key
barriers that actually ispreventing all this mass
adoption of 3D printing forpharmaceutical dosage form?
We believe that there are threemain class of key modifier
barriers to mass adoption of 3Dprinting for personalized
medicine.
Number one is based on thetechnical side itself.

(34:22):
There's really a lot ofdifferent 3D printing technology
outside from the FDN, the SLS,SLA, sse, so on and so forth,
but there's really no one sizethat fits all the different APIs
, all the different activeingredients, all the different
dosage forms that one can thinkof.
There is also, of course, whenyou want to pass on this

(34:43):
technology to the end user, suchas the compounding pharmacies,
the pharmacies in the hospital,for example.
There is often a huge learningcurve in terms of the use of 3D
printing platform.
The second category of keymodifier barriers for us,
everything is the logisticalissues.
While most of the excipientsthat's being used in 3D printing

(35:04):
are largely similar, but really, if you want all of the end
users, such as the compoundingpharmacies, to actually procure
and to maintain all thedifferent quality starting
materials.
Those are going to be quite achallenge if they were to
maintain that on top of whatthey are already having.
And, of course, finally, theregulatory some of the could be
one of the modifiable barriersas well, because currently

(35:25):
there's really no clear guidanceto setting up a 3D printing
pharmaceutical facility or evenadopting the 3D printer for
printing of pharmaceuticalsitself.
Now that is where we believethe CraftHealth printing
platform itself could actuallyhelp to mitigate some of these
barriers.
So let me allow me some time toactually introduce what we have

(35:45):
over here at CraftHealth.
What we're trying to do isreally to embed platform
solutions in industries towardstheir efforts for automated mass
customization.
We were founded in 2019, so asof now, we are already a
six-year-old company.
We are a spin-off from NationalUniversity of Singapore.
We are currently located atthis area.

(36:06):
This is the Jurong Town Councilor JTC Launchpad area in
Singapore West side of Singaporewhere it's really a
congregation of the differentstartups, accelerators and
venture capital itself, with theaim of actually promoting and
increasing the visibility oftechnologies in Singapore.
Now, over at our facility, wehave the sales office, general

(36:27):
office, r&d lab and a miniproduction area itself.
As of now we are primarilyventure-backed.
A typical 3D printing process ofpharmaceuticals.
So if you go to Google,basically the typical 3D
printing process that's involvedwill only start from designing,
slicing, printing andpost-processing.
But that is really because alot of 3D printing processes

(36:50):
they are using standardizedmaterials such as maybe ABS or
PLA itself.
For any 3D printing ofpharmaceutical, the entire
process really starts fromdeveloping the own formulations
itself.
So often it is tediousformulation development.
So those of us who do R&D forpharmaceutical formulation, you
will know that it can often takeweeks to months to get the

(37:11):
desirable dissolution profile,desirable characteristics and so
on.
But once you're done with theR&D, you'll do material
preparation.
And also for 3D printing, thevolume that's being printed
correlates strongly to the dosethat is eventually found in each
of the finished products.
So you need to determine thevolume that they printed, which
then finally design, slicing,printing, post-processing and so

(37:33):
on.
We think that all thesedifferent steps are really
cumbersome and time-consuming.
So over at Craft Health we tryto reduce that by providing
standardized premixers, where wecall them craft blends, to
actually provide an easyformulation development process,
after which we have, of course,standardized SOPs operating
process for material preparation.

(37:53):
We know that a lot of ourcustomers, a lot of our
pharmacies, do not really wantto deal with all the designing
work, slicing work, so really,we also provide the standardized
templates for them to selectand print so that can really
reduce the overall learningcurve and reduce the time spent
on developing and optimizing the3D printing process for any of

(38:14):
the new finished products thatthey may have in mind.
So this is where I introduceCraftEnable.
This is basically a platformfor software subscription itself
.
This is for standard formulasfor any new APIs using our
CraftBlends premix itself.
Really, a customer, apharmacist, for example, if they

(38:34):
have an active ingredient inmind, they can just change some
of the parameters into ourpremix calculator.
They'll be provided with therecommended composition, the
recommended weight itself forthem to prepare the different
premixers, prepare the activeingredients, mix them together
in a standardized method andthen we'll get the printing
material out.
We also provide them withrecommended 3D printing G-codes

(38:58):
which, in this case, these arethe printing instructions for
the pharmacist to actually loadthem onto the printer.
So in this case, for example,there will be a standardized
template for 700 mg total withimmediate release, tethered in
this case, of course, ourcalculator.
If the pharmacist would entersomething that is out of the
range, that doesn't work forsure, there will always be

(39:21):
prompts to tell them that thisis something that is not going
to work.
We will want them to either dosome changes so that the
formulation will work with ourKraft-Benz pre-mix.
So over at Kraft-Benz we have afull integration of the
formulations, software and alsothe hardware itself.
Our formulation, craftlens,already consists of XCPNs on the

(39:41):
US FDA grass list, all found inthe US FDA inactive ingredient
database itself.
By changing the XCPNs we areable to control the different
release profiles, which, namely,that we have is for immediate
release, sustained release,delayed release and, lastly, the
one that we have is actuallyfor GAMI formulations.
Of course, our software-wiseCraftControl is a suite of

(40:05):
software that is optimized forour printer and it also provides
an auditory function for GMPcompliance.
Finally, that is for ourprinter, and we also provide an
auditory function for GMPcompliance.
Finally, that is for ourprinter itself, called CraftMate
.
I think a unique selling pointis that again, it is semi-solid
extrusion.
There is no heat, no UVrequired for the printer itself.
This allows us to incorporate awide variety of active

(40:27):
ingredients, for example some ofthe really up-and-coming
peptides, biologics.
They are heat sensitive.
This can be actually producedthrough the use of our printer.
Basically, this is just asimulation of the dissolution of
the tablets that are printed ina simulated gastric fluid
itself.
We can do different releaseprotocols, all packed into a

(40:49):
single tablet, for example atwo-layer tablet, three-layer
tablet or even a four-layertablet itself, which, in this
case, for the four layers, theseare all immediately released
within a 20 minutes range itself.
One thing to note our craftblends.
These are standardizedpremixers and we could go as
high as 80% of the dry loadingfor our active ingredient itself

(41:11):
.
Software-wise, our craft controlsuite of software.
Of course there's always theback-end side where you do
designing and slicing one, butthat's not something that our
pharmacists will actually wantto do on a daily basis.
So really, most of the timethey're just going to deal with
a wireless interface, in thiscase over here, where they can
print, they can monitor andprovide an auditory function for

(41:34):
that.
So some of the key features onthis wireless interface will be
things like you can have yourfile management over here.
You can have a real-timemonitoring and center, also in
terms of a GMP compliance.
You can have access control tosee who are the admin, who are
the operators that can log inthrough the system to control
the printer itself.
At the end of each print therewill always be a print job

(41:54):
report that looks at what wasthe printer that is being used,
what are some of the printheadIDs, some of the materials that
is being used start time, endtime, so on and so forth.
Now this is our printer itselfCraftMate 3D printer series.
What you see here is actuallythe CraftMate production, where
there are two printheads thatcan print two different
materials concurrently onto twoseparate tablets itself.

(42:17):
So this really helps us toimprove the production speed.
We also have another smallermodel, that is the Craftmade R&D
.
That is only a single printheadover here.
Now again, the key highlight isthat this technology does not
have any heat, not any UV.
That provides us theopportunity to incorporate the
widest variety of activeingredient.

(42:37):
Again, the printer is enclosedenvironment and all the weather
service area.
These are stainless steel 306L,which are very, very
standardized pharmacy equipmentsurfaces.
Of course, all these will allowus to produce consistent
batches of the tablets rangingbetween plus minus one to 3% for
the weight uniformity itself.

(42:59):
This is really just a simplevideo of how we can actually
paint two different tablets withtwo different ingredients at
the same time, thereby cuttingdown our production rate Sorry,
cutting down the production timeinvolved.
So, as a rough gauge, 100 mgtwo materials tablet and I can
relate to get about 10 secondsto print one single tablet.
Over here we can really do ahigh degree of customization

(43:23):
across different dosage forms,such as the tablets itself,
multi-layer tablets.
Over here we can also doprinting into capsules itself,
so a single capsule can alsoretain different release
profiles within the same capsuleand some of the dosage forms,
like multi-layer.
True Oboe itself is also really, really popular, especially in

(43:44):
our region over in SoutheastAsia, singapore, or even in the
Australia APEC region itself.
So really, what we believe isthrough the use of 3D printing
platform for craft healthtechnology itself, we can
actually help to mitigate someof these key barriers to mass
adoption of 3D printing.
So, in terms of technical-wise,our semi-solid extrusion is by

(44:07):
far, we believe, to be the onethat is suitable for the widest
range or the widest variety ofactive ingredients that could be
used through our 3D printingtechnology and with the use of
craft lamps, our standardizedpremixers and some of the preset
printing instructions.
On the preset templates itself,we can really reduce the

(44:27):
learning curve that is requiredfor any of the pharmacists or
any of other clients itself interms of adopting the 3D
printing platform.
In terms of logistics-wise, Ithink we provide a one-stop
supply for all ingredients thatis required, which is basically
our craft blends, and all thissupply of quality ingredients is
really powered by Brandtech,which is a global distribution

(44:48):
company.
It is one of our key partnersin actually our expansion for
all this supply of materials andthe premixes, and that's a
regulatory-wise.
Currently, there's still noguidance, clear guidance, on
setting up a 3D printingpharmaceutical facility itself,
and we are very, very well awareof that, which is why we have
serious work in discussion withour Singapore Standards Council

(45:11):
for developing standards on 3Dprinting in pharmaceutical
compounding.
Now, before I head off thediscussion over here, I'd just
like to share some of the usecases that we have done with
hospitals locally in Singapore.
So one of them is reducingpolypharmacy for the continuous
phase treatment of tuberculosis.
Tuberculosis is important.

(45:31):
It is a community risk if notwell-controlled.
So in Singapore and I believeprobably similar treatment
overseas as well there is adirect observation therapy where
they require the nurses or thedoctors to observe the patient
actually consuming the tabletsitself.
So really what you can do nowis to combine the different

(45:52):
active ingredients into a singletablet itself, thereby reducing
admin burden on healthcareinstitution, improves adherence
to treatment therapy and overallreduction in community risk to
the spread of tuberculosis.
The second use case itself isfor supplements bariatric
supplements, itself with reducedpill burden, that we actually

(46:12):
do with another hospital inSingapore, similarly,
traditionally I think,post-bariatric surgery.
Some of the patients take up toseven different pills itself on
a daily basis to prevent theirmalnourishment of this kind of
minerals or supplements in thebody itself.
And I think a lot of them docomplain that it is very

(46:32):
cumbersome and often aftertaking all seven of them they
don't even feel like eatingtheir lunch, their breakfast,
anymore.
So what we do here is tocustomize the supplements that
is required based on thedoctor's prescription, and then
change that into a tasty,flavorful form that can be
chilled itself.
So what we provide to thepatients with really

(46:54):
multivitamin and calcium citricgummies itself that can actually
help them to improve complianceand have a better overall taste
profile in terms of thesupplements that they have to
take, so customized dosing andingredients that are not
available commercially.
That's something that we can do.
It helps to improve adherenceand overall improvement in
therapy success and healthoutcomes.

(47:17):
I think this is the last slide.
So we have partners around theworld and especially, a lot of
them are within our region andAPEC region itself ranges from
distributors compoundingpharmacies, and not forgetting a
lot of the educationinstitution distributors
compounding pharmacies, and notforgetting a lot of the
education institutions,distributors, really, and, of
course, hospitals, who are oneof our major partners as well,

(47:38):
and really we are very, veryinterested for more partnership
and we really want to see howall these collaborations,
whether be it our region orinternationally, can help us to
actually push the frontier of 3Dprinting for pharmaceutical
drug delivery in terms ofpersonalized medicine.
All right, then.
Thank you very much.
Happy to answer any questions.

Speaker 1 (48:00):
Thank you so much for a great presentation.
By the way, all those speakers,feel free to put your contact
info in the chat box if you wantpeople to contact you directly,
because sometimes it's hard towrite down the email addresses.
Yes, we have quite a fewquestions in the audience for
you, Se-Han, and so firstquestion is okay, you mentioned

(48:20):
G-code and that immediately putsome people's guards up.
I would say what software can apharmacist use if they want to
print?
How easy is the actual process?

Speaker 3 (48:32):
Right.
So really, in this case, right,I should not have used the
G-code itself, because reallyG-code is the official file name
for all the printinginstructions that the 3D printer
has.
So really, a pharmacist, if theywere to use a 3D printing
platform itself, they do notneed to sort of dabble with
G-codes, they do not need to doany designing work and so on.
With our wireless interface andthe standardized templates that

(48:55):
we have basically together,once they run through our
craft-enabled platform, they canjust select the desirable
template straight away, printthem out.
So, as of now, we havestandardized templates for
tablet size ranging from 15milligrams all the way up to
1,200 milligrams, which webelieve that is probably the
largest size that a typicalhealthy adult will be able to
swallow.
And of course, we have shapeslike a standard cylindrical

(49:17):
tablet or even an oblong orcaplet shape itself.
Definitely, we are also lookingto implement all the different
shapes that are commonlyavailable.
So any such shapes that ourcustomers would like to have,
they can let us know and we canupload these standardized
templates for them to choosefrom.

Speaker 1 (49:34):
So you do not really need to know how to write G-code
.
That's the answer, right,exactly, that's right.

Speaker 3 (49:39):
Sorry for my technical term just now.

Speaker 1 (49:41):
Yeah, it's good to know that that exists, because
that's what's powering themachine.
Okay, another question fromKadi Samuel If the machines were
orders of magnitude moreproductive, would you see
opportunities to centralizeproduction and ship products to
customers and pharmacies?

Speaker 3 (50:00):
Yes, definitely.
So.
One of the key advantages forthis kind of machinery is really
that it's automated.
It could be automated togetherwith the use of robotic arms and
so on.
So I would say there'sdefinitely opportunity for this
kind of mass production orcustomized tablets and so on.
What the human or what thetypical compounding pharmacist

(50:21):
may not be able to do is to do24-7 lifestyle production.
So, with a fully automatedsolution, I think that's
definitely something that ispossible in the near future and
something that we could explore,especially, for example, for
hospitals or for brand ownerswho are looking to actually
produce some of these complexgeometry kind of tablets or
gummies itself for their ownusage.

Speaker 1 (50:45):
Got it?
Okay, we have this really longquestion.
I'm just trying to.
You can read it yourself,senghana as well, in the QA box.
I think it's okay.
So I understand that you need akind of drug encapsulation to
control drug release, but why doyou need to print it?
For example, encapsulating adrug in PLGA nanocapsule, mixing

(51:08):
it with an injectable polymer.
Why do you need a specificarchitecture?
So why is the shape important?
Layer by layer?
Why not just fill the whole ofa capsule?

Speaker 3 (51:18):
Right, right, right.
So definitely that's a commonquestion itself, right For us.
Really, what I feel thatthere's, the key area that 3D
printing can actually shine, isreally in those that is
customized.
So really, if you're looking atjust a single ingredient tablet
, something that we can do forsure, no problem.
But I realize that some of theimages that we show are really

(51:39):
always about multipleingredients into a single tablet
itself.
One of these technicaladvantages over traditional
tablet press itself, for example, I think most of us will have
seen bilayer tablets in one wayor another.
For example, something that'svery commonly prescribed locally
in Singapore is Anorex, that is, paracetamol and orfenadrine
stacked together in bilayer.

(52:00):
But really for traditionaltablet press, anything more than
two layers, they're going tohave increasing difficulties
producing that.
So, really, what shines for 3Dprinting, especially in our
craft health printing platform,is really combining three or
more ingredients.
Itself.
That allows us to do that heavycustomization that traditional
production is not able to do so.

Speaker 1 (52:23):
Right Makes sense.

Speaker 3 (52:25):
Okay.

Speaker 1 (52:25):
One last question.
I want to know whether thereare 3D-printed commercialized
drugs other than Spiritan, whichis FDA-approved right now.
Do you have?

Speaker 3 (52:38):
any.
Correct me if I'm wrong.
Basically, there are no otherFDA-approved 3D-printed
commercialized drugs.
There are still under clinicaltrials, especially those that
are coming from China.
China is aistec itself.

Speaker 1 (52:54):
That's a large production machine.
Yes, that's right.
That's right, Okay, well, thankyou so much.
We'll come back to you withpanel discussion.
Thank you so much for greatquestions, guys.
We're going to introduce ournext speaker, who is Dr Nicholas
Sentler, who is the co-founderand CTO for Curify Labs.

(53:17):
He also has a decade-long ofresearch experience and
commercialization experience inthe field.

Speaker 4 (53:27):
Can you see my screen?
I can't see myself.

Speaker 1 (53:33):
Presentation mode not yet.

Speaker 4 (53:35):
Oh, yeah, yeah, we're in for presentation mode.
There we go, maybe.

Speaker 1 (53:38):
Yes.

Speaker 4 (53:40):
Great.
Thank you so much for invitingme to speak today.
Such a great session andexperts around the table experts
around the table.
It's my pleasure to speak aboutCurify Labs and really how we
see the world of changingpharmacy compounding and how we

(54:00):
can bring automation,digitalization and 3D printing
to personalized medicines.
My background is in pharmacy.
I'm a pharmacist, phd inpharmacy.
I've worked in academia both inFinland and actually New
Zealand as well.
Then I have, during my career,worked in the industry as well,

(54:24):
for instance, as a Seneca inmaterial science in the UK.
Then I became a professor atÅbo Akademi University in
Finland and during that time weactually really explored the
possibilities of 3D printing andother printing technologies in
making personalized medicines.
And then I've spent some timein a scale-up company, nanoform,

(54:48):
and then, finally, we foundedCurify Labs to really change the
way pharmacy compounding isdone and how we can bring more
automation through thenon-sterile manufacturing of
drugs, and to basically take itall the way back.
My mother was a compoundingpharmacist she's in the picture

(55:09):
here and I think I got the sparkof being a pharmacist from her
and then also solving theproblem of manual compounding.
So we were founded in 2021.
We have a headquarters inHelsinki, which there is in
Germany and the US.
We have also actuallywarehouses in Germany and the US

(55:35):
as well, so we can provide allthe or our services on both
continents.
Based on 10 years of academicresearch, we're currently active
on 13 markets.
Currently 27 members andexpanding in the team and, as I

(55:57):
said, our main focus is oncompounding pharmacies and
hospital pharmacies.
But the technology itself it'sapplicable to, you know,
manufacture GMP type manufacturealso in the pharmaceutical
industry.
So one of the problems incompounding and the access to
medicines in pediatrics is, ofcourse, huge, as you know.
So 50% of the medicines are notavailable in doses or

(56:17):
formulations approved forchildren.
This is why we also exist.
We exist for bringing patientsthe cures they need.
So this is why compounding alsoexists.
When there are no registereddrugs, somebody needs to do it
and somebody is typically acompounding pharmacist or a

(56:38):
hospital pharmacist, and there'sa need for personalization on
different levels.
There are different treatmentresponses, swallowing
difficulties, the doses are notcorrect, both on the human side,
but specifically also on theveterinary side.

(56:58):
If we look at the technologydevelopment timeline for
Curitiba Labs, the academicresearch started in 2009 when I
became a professor.
Research started 2009 when Ibecame a professor, and then we
founded the company 2021.

(57:19):
We started directly workingwith pharmacies, so we had
paying customers who were reallywanting to explore the
technology.
And veterinary patient dosingstarted already in 2021 in
compounding and there I have tocorrect Alvaro a little bit
sorry about that we startedcompounding pharmacy printing

(57:42):
already in 2021 in vets and then2023 in on the human side, so a
little bit earlier than 2023 onthe human side, so a little bit
earlier than you guys, but allthe kudos to you.
You've done a great work in thefield.
So it's great that we havedifferent players in the field.
We did this multi-site study in30 pharmacies across Europe in

(58:03):
2023, published the results in2024.
And during that study, wereally collected information
from the field.
What is relevant for thecompounders out there?
How should a system like thislook like?
And then we launched our firstofficial pharma printer and our

(58:23):
first GMP manufacturedpharmaceutical inks or excipient
bases, as we basically callthem in October 23.
And yeah, the first printingshappened already for patients in
2023.
Just if I look basically lookinto what has been what my
research group was doing during10 years and what led to Curify

(58:47):
Labs.
So we did this and that withinthe field you can see, we
started with inkjet printing andthen both 2D and 3D inkjet
printing, fdm printing,flexography, started integrating
quality control tools andexploring them different
spectroscopic technologies,colorimetry, so on.

(59:09):
Even explored inkjet printingand QR codes, where the ink had
drug substances in them and thepatient information Cool
projects, maybe not soapplicable in real life Stencil
printing.
And then we started going moreand more into real work cases

(59:31):
hospital systems and hospitalpartnerships, warfare influence
in 2019, and then also focusgroup studies, interview studies
within the staff, to understandwhat to do in the best possible
way.
This is just to highlight thevalidation study that we did
across Europe in 2023, with alot of hospitals across Europe.

(59:59):
So automation in pharmacycompounding comes with many
benefits.
So we can decrease costs bystandardizing the methods and
the fast compounding.
The validated processes, thetraceability and built-in
quality control tools increasethe compounding quality and, of
course, in the end, the betterpatient outcomes are the key.

(01:00:21):
So with the various dosageforms and flexibility in dosing,
we can reach that.
As you can see, we have a lotof similarities in the speakers
from before, so maybe smalldifferences, but obviously we're
speaking about the same thing.
So we want to change the waymanual compounding is done.
We've shown in the study thatwe can be four times faster with

(01:00:44):
the processes that we havecreated, and I want to highlight
that 3D printing as such, orwhether it's called blister
filling or extrusion directlyinto packaging itself, it
doesn't solve a problem for thecompounding pharmacist.
It's a complete workflow.
It's a complete process.

(01:01:05):
All the steps have to be inplace.
The technology of Curify Labssupports multiple dosage forms,
as you can see in the picture,and let's jump into how it
actually works.
So we also like to say it'sinspired by 3D printing, because
it's not solely 3D printing.

(01:01:26):
It's also liquid dosing, liquidhandling and so on.
But we do create often 3Dprinting.
It's also liquid dosing, liquidhandling and so on, but we do
create often 3D structures, soin that sense it also can be
considered as a 3D printingtechnology.
So our offering for pharmaciesis kind of fourfold.
We have the proprietarypharmaceutical excipient bases,

(01:01:50):
a software platform, roboticsand 3D printing and integrated
quality control, and the endresult is the standardized
dosage forms from tablets tocapsules, and you can even you
know dose ointments and ordispersible films and so on.
Even if we offer theseproprietary pharmaceutical

(01:02:12):
excipient bases our system.
We don't force our customers touse them.
It's fully possible to useother ingredients in our machine
as well or find the rightparameters in the system.
But we have learned thatpharmacies are busy and they

(01:02:33):
should be concentrating on thepatients, not tweaking
parameters in a printer.
So we have wanted to come witha plug and play digital
component platform for forpharmacies.
And in the core of everything isour formulation library, which
is growing, growing day by day.
You can see here what type ofdata there is for our customers.

(01:02:54):
We have the human formulations,for instance, and we build in
our laboratory quality dossiersfor each formulation.
So the pharmacists can restassured that if they use the
batch protocols provided theyget the stability data, they get
the cleaning validation data,they get the solution profiles

(01:03:14):
and process validations of these.
For instance here,spironolactone nine months
stability.
And this is what we do forevery formulation in the library
.
And if we look at basically thetherapeutic areas that we cover
at the moment, everything thatwe do comes from the field.

(01:03:35):
So if there's a request from acustomer, we start developing
that formulation and get it tothe library and everybody who
has our system can start usingthat formulation when it's
launched.
So this is the basic idea, withno extra cost of using that
formulation when it's launched.
So this is the the basic idea,with no extra cost of developing
that formulation.

(01:03:55):
So the workflow.
Workflow is simple.
There's an order order creation, weighing, mixing, dosing and
then sealing, labeling.
And if we look at an orderorder creation here, let's see
if it starts there we go.
So, basically, simply, from theformulation library, you choose

(01:04:16):
the drug that you are going todose Ramipril in this case then
you choose the dose you can alsochoose multiple doses if that's
interesting and then reasonableand then the number of tablets
and then you create the order.
The order is created on a webapp which is then sent to the

(01:04:38):
printer that you're using.
So you can have multipledevices.
You can control all the orderhandling centrally.
Let's look at the excipientbases really quickly.
These are GMP manufacturedbases, which means that they are
produced under the samerobustness and quality than any

(01:04:59):
drug product on the market.
So all the excipients arepharma grade, analyzed according
to GMP and released accordingto GMP.
Analyzed according to GMP andreleased according to GMP.
And currently we have thesebases on the market.
So gel tablet base, suppositorybase, two different anhydrous

(01:05:20):
bases, oral films and then thesechewable gel tablets for
veterinary purposes as well.
So why these type of bases?
We need to be able to cater, ofcourse, to different types of
dosage forms, but then also drugsubstances have different
properties, so then we need tobe able to match those

(01:05:40):
properties to the API.
Obviously and here you can seesome presentations of the
tablets from the field, so youcan see there are differences
how they look like.
So once again, the oral basesare GMP manufactured and they

(01:06:01):
are all optimized for thisautomated dosing system.
There are a number of excipientbases out there, but they are
obviously not optimized to workin these printers always in the
most optimal way.
So that's at least a guaranteefrom our side that if one uses
the CuraBlend bases, that's thenstudied properly and we provide

(01:06:25):
all the for our customers.
We provide all the informationabout the ingredients in there,
because the prescribers need tounderstand what components are
there, Are they suitable forpediatric patients and the
allergies that patients mighthave.
So we disclose everythingthat's in there.
The beauty of printing.

(01:06:46):
We've heard of the flexibilityof dosing.
This is just an example of howwe can dose very flexibly any
dose and of course, the kind ofthe promise of 3D printing or
this type of automationtechnology is that you can alter
the dosing regimens and then,of of course, combine tablets A

(01:07:13):
little bit of the regulation.
I would say that it would begreat that we also, as a joint
force, from the people who areactive in this field, of
companies.
Typically, when we use 3Dprinting technologies we produce
tablets or dosage forms ingeneral that are already

(01:07:35):
described in the pharmacopoeias.
So from that point of viewthere's no regulatory hurdles or
regulatory differences.
For instance, for a tabletmachine, if you read carefully
the USP or the EuropeanPharmacopeia, in the
introduction here it says thattablets can be produced through

(01:07:57):
extrusion.
So by definition it would meanthat extruded tablets can come
from a 3D printer.
So that's kind of my messagetoo, because often there is a
little bit too much emphasisthat there should be regulatory

(01:08:18):
sort of guidance.
Of course there has to be anunderstanding also, but it
doesn't differ so much.
The end products are dosageforms that exist.
We take quality seriously andthat's where we have a
certificate ISO certificate onthe 13485, which is a medical

(01:08:38):
device certification.
The machine itself is not amedical device, but it.

Speaker 1 (01:09:32):
Thank you, okay.
Okay, I thought that was theproblem, but I guess we lost him
.
I will sure to help reviveNicholas there, but meanwhile,
since I don't know when we'regonna to have him back, maybe we

(01:09:52):
should just start with our nextspeakers also giving time plus.
So I'm going to introduce ourlast but not the least speaker,
dr Thomas Forbes.
Thank you so much for stayinguntil the end for the finale.
So okay, I need to do a properintroduction.
Dr Forbes is a researchscientist at the National

(01:10:16):
Institute of Standards.

Speaker 4 (01:10:17):
Oh, you're back, I'm back, sorry, I wasn't sure, so I
have to start the next one.

Speaker 1 (01:10:22):
So maybe we can also kind of just wrap up if you're
already at the end.

Speaker 4 (01:10:28):
Yeah, can I?
Yeah, maybe I'll do it.
Yeah, go ahead, go ahead.

Speaker 1 (01:10:30):
Well, I will reintroduce Dr Forbes.

Speaker 4 (01:10:33):
Yeah, sorry about that.
I don't know what happened.
Yeah, can I use a few moreminutes or?

Speaker 1 (01:10:38):
Yeah, please, yeah please.

Speaker 4 (01:10:43):
Okay, so a standard process would look like this
Very simple, weighing the APIand the XDP base.

Speaker 1 (01:10:49):
Your screen is not shared, just so you know.

Speaker 4 (01:10:52):
Oh, that's strange.

Speaker 1 (01:10:55):
So we're going to skip the question part, since
we're kind of short on time nowyeah sure, sure.

Speaker 4 (01:11:04):
Can you see it now?

Speaker 1 (01:11:08):
You're in a different kind of presentation mode.
Okay, yeah, there you go.

Speaker 4 (01:11:15):
Okay.
Okay, so the process was shownthere.
You can see the printinghappening.
Here we have an integratedscale in the system, obviously
100% mass uniformityity.
If the printed tablets are outof spec the circle on the screen
would be red and then it wouldprompt you to replace that

(01:11:36):
tablet.
But you can see the speed ofprinting is about one to two,
one to three seconds per tablet,depending on, basically, the
dosage form.
And here just a similar examplefrom Kraft Health iso-niacin
rifampicin layer tablet.
So basically you just dispensethe tablets on top of each other

(01:11:58):
and then form a multi-systemtablet and we have customers
shown time savings, for instancefor suppository manufacture 18
minutes time saving for 30suppositories compared to manual
methods.
And then very quickly use casesfrom hospitals.
The technology is in clinicaluse and these are cases from

(01:12:24):
Germany, minden Hospital.
They started with forest andmild and prednisolone.
This is from Tartu.
A nice desensitization studyfor aspirin Worked a lot with
rare diseases.
This is for one compound,epalrestat.
This is from Naples.
Leukemia patients have beentreated with dasatenib and our

(01:12:46):
tablets were reallywell-received.
20 patients dosed AT preferredour gel tablets.
Princess Maxima Center CancerHospital in Europe mines doing a
large palatability study.
At the moment we have a largecompounder in Sweden basically
doing all the compounding inSweden using two of our devices

(01:13:08):
and then compounding pharmaciesin US.
This is one, this is anotherone and St Jude Children's
Hospital are startingimplementation as we speak.
We just came out with a studyon hydrocortisone dosage forms
where we did a tech transferthere on those, and we're also
active in drug shortage agilemanufacturing project.

(01:13:30):
We're running this RoboFarmproject in Europe.
So it's about basicallypreparedness and so on.
So thank you so much.
3d printing is reality already,as we've heard today, and
there's room to grow.
There's a lot of basicallybenefits from the technology and

(01:13:53):
thank you so much for listening.

Speaker 1 (01:13:57):
Thank you, niklas, sorry to rush you at the end
there.
There are a couple questions inthe Q&A box you can type in the
answer.
They're great questions, but wejust have to move on.
Of course, and also this is toall the speakers If possible,
I'd like to request a copy ofyour presentation to share in
PDF files.
It's totally fine Later on withthe audience in case people

(01:14:19):
miss some details, if they wantto go back and take a look.
All right, so let's move on toour final speaker, finally, dr
Forbes.
Thank you so much for joiningus today.
He is a research scientist atthe National Institute of
Standards and Technology, anagency of the United States
Department of Commerce whichadvances critical measurement

(01:14:39):
solutions and promotes equitablestandards to stimulate
innovation and industrialcompetitiveness, and he leads a
program at NIST investigatingthe measurement science and
potential standards needs for apharmaceutical production
paradigm that shifts towardsagile distribution and
point-of-care manufacturing.

(01:15:00):
Take it away, tom.

Speaker 5 (01:15:06):
Great.
Thank you for the introductionand thank you for everybody
sticking around.
And so I'm Tom Forbes and I'mgoing to talk more about the
metrology here and try and kindof focus on the things that
might be different from theother presentations and kind of
give a different perspective,not being commercial.
So just real quick disclaimersand disclosures any of the

(01:15:28):
opinions are my own and not thepolicies of NIST or the US
government.
Any commercial products Imentioned are not intended to be
a recommendation or endorsementby NIST and I have no competing
financial interests.
And so, real quick, if you'renot familiar with NIST, the
National Institute of Standardsof Technology, we were
originally founded in 1901 asthe National Bureau of Standards

(01:15:48):
in the US and then later in the80s became NIST and we're a
non-regulatory federal agency inthe Commerce Department.
And so we are the US's NationalMeasurement or Metrology
Institute, an NMI, and countriesaround the world have these
NMI's for setting measurementstandards in related areas.
And so the NIST mission is topromote US innovation and

(01:16:11):
industrial competitiveness,specifically by advancing
measurement science, standardsand technology.
And so that's where I'm goingto try and focus today.
And so NIST does a wide rangeof things.
We do things from disasterfailure studies, so
investigating the collapse ofthe World Trade Centers.
Reference materials you mightbe familiar with physical

(01:16:31):
materials reference datacalibration services.
Nist plays a big role indocumentary standards and these
are usually in collaborationwith ASTM or ISO.
And then we also investigatecritical and emergent
technologies and we have a largeintramural and extramural
manufacturing program, and sofor all these things we're
really looking to aid for theadoption of technologies, those

(01:16:55):
that are critical today and thenthings that are coming up in
the future, and we do anythingfrom basic to applied research,
and a lot of this has to do withmanufacturing and standards,
and so all those things kind ofhave combined with this increase
in point-of-care medicine, 3dprinting, those technologies,
and a lot of this was summed upnicely in a paper by the

(01:17:16):
National Academies of Science,engineering and Medicine that
was really focused on advancedmanufacturing technologies for
pharmaceuticals, and so thisranged from high-throughput
things like continuousmanufacturing to 3D printing and
additive manufacturing, whichwe've seen in the last three
talks, and the overall ideabeing to improve quality,
address things like shortagesand, for new drugs, improve that

(01:17:38):
time to market.
And so with a lot of thesetechnologies, specifically the
3D printing, additivemanufacturing, everything we've
seen today we can move more fromhaving a single centralized
manufacturing that's doing highthroughput, a select number of
doses, to something that's moredistributed, where there are
smaller, either distributedmanufacturing sites or even

(01:18:00):
point of care manufacturing.
And so this is a lot of what weheard Can you put these
printers into pharmacies, intohospitals, right where the
patients might need them?
And this is a schematic kind ofhow this might look in the US
or around the world.
On the right here of why youmight want to be able to

(01:18:23):
personalize your medicine.
Some of it is the agileresponse to localized needs.
If there is a natural disasteror an epidemic that's localized,
can you increase production inthat local area.
Personalization for specificpatient groups like pediatrics
or geriatrics, allergies thatyou might want to remove a
component from doses.

(01:18:43):
Rural pharmacies in the US makeup almost 90% of the pharmacies
, yet they might not have accessto every single dose level or
immediate supplies of those, andcan they produce those on site.
And then we're getting intosmall batch clinical trials,
hospitals, urgent care, andwe've heard a lot of this and
great examples of how this isactually being done currently,

(01:19:04):
and so in the past few years FDAhas also had, so the Food Drug
Administration in the US has hada workshop and reports on this
distributed manufacturing ideaand how they can prioritize this
distributed and appointed caremanufacturing.
And then, of course, being theyare a regulatory agency, how
can they make that frameworkabout science and risk-based?

(01:19:25):
And so this is kind of whereNIST can play a role into
helping to develop themeasurement science, what
control strategies on certainanalysis, a lot of what we do
for a lot of areas towards this3D printing of pharmaceuticals,
and so this would be to supportproduction, equipment,
technology and industry.
Like we've seen from thespeakers today, it could also be

(01:19:46):
process analytical technology,so companies making those
quality control, qualityassurance instrumentation that
might work in conjunction withthem, and then helping other
agencies, government agencies orregulatory agencies understand
how this works and in what areasare limitations and whatnot.
And so we've kind of heardexactly how this might work

(01:20:08):
through the last couple of talks.
But there can be a scenariowhere you still have a
centralized or distributedmanufacturing site producing a
pharmaceutical ink that is thendistributed to your pharmacy and
that is already formulated, andthen you're producing these
personalized dosages or specificneeds on site, and so we've
kind of looked at this, themetrology around this, based on

(01:20:28):
three kind of separate unitshere that active pharmaceutical
ingredient, the ink, theformulation on the front end,
then how you're depositing it.
So this has been 3D printingextrusion.
I'm going to discuss adrop-on-demand printing
technique and then what yourpersonalized dosage might be.
In this case the deliveryvehicle could be tablets, but it
could be a number of otherthings, and so we've heard about

(01:20:53):
a lot of active pharmaceuticalingredients that have been
demonstrated today.
We've been interested so far innarrow therapeutic index drugs,
so things that you have to haveprecision over and you might be
adjusting for your patientacross time.
So you might want to increase alittle bit, but anything too
much as it could be toxic, toolittle is not effective.

(01:21:13):
We've also looked at SSRIs, soantidepressants and also opioids
, so things that you might wantto taper off of or your doctor
might want to adjust on the fly.
So can you do small batches ofthese and have it personalized.
And then we have othergovernment agencies that are
very interested in medicalcountermeasures, so there's a
list of medical countermeasuredrugs and can we have the ramp

(01:21:36):
up of this kind of productionlocalized, based on natural
disasters, supply shortages,that type of thing, and so this
is kind of where we've beenlooking.
That second component is goingto be your deposition, your 3D
printing, your solid stateextrusion.
In this example, basically, wewere using a semi-solid
extrusion, like you saw in acouple of the videos so far, to

(01:21:57):
print blank tablets, and so thetablets will just have your
excipients and your bulkmaterial, and then we use a drop
on demand system that can putdown precise amounts of your API
, your API ink, into thosesemi-solid tablets, as they're
still liquid and solidifying,and so, just kind of a schematic
here you have the nozzle with apressure pulse and then there's

(01:22:18):
an LED and photodiode to counteach one of those droplets, to
kind of give you that real-timefeedback of your dose control by
tablet.
And so then, finally, thedelivered vehicle, and I think
we've seen examples of thisacross the board today.
This could be anything fromtablets, oral dispersible films,
capsules, single-dose liquidsyou know I've seen a lot of

(01:22:40):
these for pediatric drugs but,as we've heard from the
questions, questions too the APIor your dissolution profile or
the patient themselves mightactually dictate what is the
most appropriate vehicle foryour use, and so one of the big
things that the FDA in the US isinterested in is usinga quality

(01:23:02):
by design approach for thispharmaceutical development, and
so really they're trying to havethe quality and the assurance I
guess is a kind of design intothe beginning of the process.
And so they want you tounderstand the product of
processes when you're designingyour whole throughput.
And so this also involves arisk assessment.

(01:23:24):
So what processes have thehighest risk, what increased
variability, what might lead tonegative outcomes in your
production, and then whatcontrol strategies do you have
in place for these?
And so all of that is goinginto the final goal of ensuring
safe and effective clinicaloutcomes for the patients.
And as I talk about a couple ofthese, I was happy to see that

(01:23:45):
this was addressed in prettymuch all the presentations today
of how these companies areputting in control strategies
and traceability.
And so in this quality by design, you can often think of each
process as a pharmaceutical unit.
You can think of what's comingin and you want to evaluate the
critical material attributes ofwhat's coming into this process.
You want to understand whatprocess parameters are playing a

(01:24:08):
role and then identify thecritical ones, and then what is
coming out, what outputmaterials, and then what are the
critical quality attributes forthat.
And this is just an example ofhow you might look at, you know
the material properties for thebulk, the API, other excipients,
how you're affecting it.
So with 3D printing it could bethe pressure, the temperature,

(01:24:28):
these types of things.
And then quality attributes canbe the quantity, content,
uniformity a lot of what youtraditionally have seen with
pharmaceuticals and this canalso kind of be done in series
method, where the outputmaterials or the quality,
critical quality attributes ofyour first process can then be
the input materials for yoursecond process and then again

(01:24:50):
those outputs become the inputsfor the final one, until you
have your final product.
And just to give a coupleexamples, we can look at the API
deposition and we caninvestigate parameters that are
critical to that drop on demanddosing, and we can look at where
the biggest, highestuncertainty comes into play,
based on the number of droplets,the liquid properties, the

(01:25:12):
printing properties, and then wecan have the credit quality
attributes coming out.
So do we know the exact dose ofwhat we've put down in each of
these?
And then we can move to thenext stage, which would be the
delivery vehicle, and this islooking at an example of
cytoprame tablets, and this islooking at an example of
cytopram tablets, and so thisfirst figure is your blank
tablet.
So this is semi-extruded into atablet mold, or it could be a

(01:25:34):
blister pack or capsules, aswe've seen.
And then the drop-on-demandsystem is putting the two
milligrams of cytopram into eachone of those tablets, and so
our critical quality attributesfor that final product are going
to be is this the dose we meantto print?
And then do we have a contentuniformity?
Are we pruning all the dosesthe same?
And so a big way to address thecontrol strategy.

(01:25:59):
So where is the highest amountof risk?
And then where can we put insteps and verifications along
the way?
And so we kind of just wentalong our three unit operations
here and we can look at at-lineverification of that ink that
you're starting with in-linemonitoring of your production
and then at-line or onlineconfirmation of what you've
produced, and so this can looklike you're taking your ink,

(01:26:22):
you're using a spectroscopictechnique.
So this is an example justusing simple UV absorption where
it's a Warfarin pharmaceuticalink and you can see that after a
week you know you're still inthe liquid phase and then after
a couple months that Warfarinwill start to crash out a
solution and you can see thisdifference in your absorption
and you can catch that ahead oftime.

(01:26:43):
And so this could also be ifyou know it was sitting on the
tarmac and there was somedegradation, can you catch it
before you even start yourprinting?
For the system we were lookingat, you can get a traceable
report for each dose for thenumber of droplets.
So if you miss droplets youhave the choice to go back and
redeposit those into thatspecific dose.

(01:27:03):
You can eliminate that dosefrom your batch.
But you're having this real-timemeasurements and we've seen
with the talks you can havereal-time measurements of the
gravimetry of the tablets asthey're being produced
microscopy and I'll mention thata second here when we get to
the atline and online batchconfirmation, and so there are a
lot of analytical techniques.

(01:27:23):
You can gravimetry formeasuring tablet weights.
You can actually measure tabletdroplets being ejected.
Microscopy is big in yourtraditional 3D printing, so can
you use machine learning or AIto identify when a print is
going bad prior to finishingSpectroscopic techniques.
We've heard about NIR, ir, uvviz, raman and a lot of the

(01:27:44):
metrology we're doing is helpingregulatory stakeholders and
industry understand limitationsof some of these measurements
and you know, for example, raman, if you're getting into a low
concentration, into a high bulkmaterial, you're going to have
difficulty seeing that lowconcentration API.
And so what are the limitationsof these instrumentations that
someone might want to put inplace for this area?

(01:28:07):
And then, as the printingtechnologies improve and
increase, we've also seen animprovement and decrease in size
for more on-site, very specifictechnologies such as mass
spectrometry.
And so as these instrumentsbecome smaller and smaller, they
may not be something you'reseeing at a pharmacy, but if you

(01:28:28):
have a distributedmanufacturing site or one of
these on-demand pharmacies whereyou're rolling up with a number
of trailers and you're settingup a pharmacy in a natural
disaster, you might have thisanalytical technology for your
quality control.
And so I was happy to see thiswith these companies too A
traceable production report.
You know this is critical forunderstanding what you started

(01:28:50):
with.
What's in the doses?
What the batch looks like, isthe content uniform?
Are the doses correct, thattype of thing.
We saw that again and againtoday, and so most of what I've
talked about has beenmeasurement science.
But I also want to, you know,socialize with the community and
everybody here today kind ofmore.
What can we do beyond themeasurement science.

(01:29:12):
So standards, documentarystandards, what could really
push adoption of thesetechnologies and help not only
pharmacies, hospitals, implementthis, but what might regulatory
stakeholders want to see orneed to see?
And so standards are criticalkind of for enabling comparison

(01:29:33):
and interoperability acrossthese different technologies.
And as more come out and emerge, we want to promote the
research manufacturinginnovation.
Can some of these technologiesand these unique capabilities
been translated acrosstechnologies, expanding adoption
?
Obviously in manufacturingcapacity?
If this is going to play a bigrole, how can we increase that

(01:29:55):
capacity for this type oftechnique?
Secure supply chain, cyber, aswe see, a lot of these have very
sophisticated softwares withthem.
Can we ensure that those aresecure within themselves?
And then, if they're speakingto each other across that type
of a supply chain and thenstreamlining the regulatory
review Again, can we help theregulatory agencies understand

(01:30:20):
what they need and what might bethe limitations and the
benefits of this type of thingto reduce the cost and time to
market?
And so this is kind of reallyfor us at NIST interacting with
the stakeholder community.
You know everybody herepharmaceutical industries,
public health organizations, thehospitals and pharmacies
themselves, instrumentationindustry.
So that's everybody who'sspoken today.
That's also the processanalytical technology industry.

(01:30:45):
And then patients, you know,and then patients, you know, we
need patients to be confident in3D printed drugs.
We need them to be assured thatwhat they're taking is as good
as what they might get from ahigh throughput centralized
manufacturing site.
And so, really, nist isinterested in identifying are
there new measurement scienceareas that need to be addressed?

(01:31:06):
Standards Obviously, usPharmacopoeia has a lot of
monographs and specifics forcompounding in the traditional
sense.
Can we help evolve those and,you know, work with them on
specifics for something likethis, and, again, engaging
stakeholders.
So this could be NISLEDGEConsortia, this could be some of
the other internationalorganizations that bring in US

(01:31:28):
Pharmacopoeia, regulatoryagencies, partnerships and other
workshops in this type of area.
And so then I'm just going towrap up with one last slide and
just kind of give you an idea ofpotential avenues.
And so these are areas thathave come out of NIST that are
similar but might be applicableto something like 3d printed
pharmaceuticals.
And so um nista collaborated ona standard guide for bio inks

(01:31:51):
using bioprinting, and so thiswas put out through astm, and so
it's really kind of developingand providing a consensus
terminology for how you'retalking about these things
material properties that arecritical for bio inks in
bioprinting, different printingmodalities, and so these types
of documentary standards can beused for somebody to point to,
for you know where to getstarted, how to do things, and

(01:32:14):
this could be ASTM, it could beISO, it could be NIST guidelines
, it could be US Pharmacopoeia,but those types of things might
help everybody kind of beworking from the same playbook.
Nist also has reference data andtools.
So this could be standardreference data, which is often
provided through vendors, or itcould be more just public data

(01:32:35):
repositories.
So NIST publishes all data fromstudies, but also does
libraries and databases.
So there's a NIST NearIR sortdatabase and this is NearIR
Spectra for textiles and it'smeant to aid in the textile
recycling industry and they'respecific to have you know the
database of the Spectra.
They've made it all machinelearnable.

(01:32:57):
There's a lot of machinelearning AI going into NearIR
for recycling, and so issomething like that useful for
this community.
Another example is the NISTDart MS Forensics Database, and
so is something like that usefulfor this community.
Another example is the NISTDart MS forensics database.
So this is mass spectraldatabase specific to forensics.
You know has over a thousandcompounds.
But it not only has the library, it also provides a free and

(01:33:17):
openware data interpretationtool.
So how you can match thelibrary with your spectra.
Inter-laboratory studies are abig thing that NIST likes to
produce or participate in, andso NIST has a larger additive
manufacturing program andthey've put out interlaboratory
studies with ceramic additivemanufacturing, where they looked
at a number of laboratoriesusing the same printers, and

(01:33:39):
also polymer, photopolymeradditive manufacturing, whereas
24 laboratories using alldifferent types of printers, and
they're trying to look at theinteroperability of working
curves developed for those VATphotopolymerization things.
And then finally, referencematerials.
You know US Pharmacopoeia has alot of reference materials for

(01:34:00):
traditional pharmaceutical areas.
Nist has a monoclonal antibodyreference material and then
other reference materials thatare more not the drug themselves
but related to those types ofproductions, and so is something
like this maybe, you know,maybe a test grade material or
test grade formulation foreveryone to kind of be used to
verify or calibrate systems, andso hopefully this kind of gives

(01:34:24):
you a flavor of what might beuseful and what might help the
industry, but kind of giving adifferent perspective.
That's the presentation todayand thank you for listening and
thank you to all the otherspeakers today.
It was great to participate.

Speaker 1 (01:34:42):
Thank you so much.
Wow, this is like a whole newfield that I never knew.
I didn't know about NIST andnow I realize how important you
guys are.
Okay, one question from theaudience, from Luciano Bragio.
Very insightful presentation,thank you.
Are you in the process ofconceiving any ad hoc process
analytical technology workflowfor these type of manufacturing

(01:35:07):
technologies?
Have you heard of this?

Speaker 5 (01:35:10):
So a lot of what we're doing is kind of
investigating the measurementscience limitations and where
areas work for processanalytical technology.
We are not necessarilydeveloping new novel process
analytical technology.
This does develop technology.
I don't know that we arelooking at that in this area,
but it's more of these are thetechnologies that are being used

(01:35:32):
and we know like we heard a lotabout near IR and obviously
Raman and UVViz and otherspectroscopic techniques are
being used, and so we're usuallyinvestigating those for this
specific area.
How might they be implemented?
What limitations might theyhave?
Kind of to give the communitysomething to work off of.

Speaker 1 (01:35:49):
So already pre-existing technologies,
anything that actually is, Imean might as well just bring
all the panelists to the screen.
Now to ask this question is forthe quality control process,
the whole thing that we've beenlistening in the last 15 minutes
.
Is there anything that's 3Dprinting only that other
traditional manufacturingprocess does not rely on?

(01:36:11):
But because we have a newprocess and therefore we need a
new quality control process.
I mean for like yeah, yeah, youcan start.

Speaker 5 (01:36:24):
A lot of it is, or at least for the analytical
technology where you're lookingat.
You know a signature orsomething.
It's for dose measurement, andso you're trying to quantify
that what you have is correctand that's going to be the same
across traditionalpharmaceuticals and these.
You might have differentexcipients in your 3D printed
things, but the technology isgoing to operate the same either

(01:36:47):
way.

Speaker 1 (01:36:48):
Okay, that's actually reassuring.
All right, so we are definitelyover time, but I like to just
have a little bit of a paneldiscussion, if people are okay
with that.
So I like to bring everybody onscreen, okay.
Well, number one question isvery general.
So what is your number onechallenge right now along your
line of work?

Speaker 5 (01:37:09):
I'll start with you, thomas, since you're the last
speaker are there critical needsthat still don't exist, and how
the 3d printing needs areunique to this area, um, that

(01:37:31):
aren't already being addressedby you know, the pharmacopias or
the other uh, you know astm,iso, and so there are some
unique areas, and so kind of ourchallenge is understanding
where nist might play a role andhelp out, and then what I think
what FDA really wants to see,or how they're going to.
You know, is this just going tobe traditional compounding?

(01:37:52):
And then the technique.
The technology doesn't actuallymatter, it's more about the
drug.
Will it stay that way?

Speaker 1 (01:38:01):
Okay, well, I think we have a couple of experts that
can maybe answer that questionor help on that, so I'll start
with Alvaro.
What do you think?

Speaker 2 (01:38:11):
Well, I don't have a clear answer because it depends
from country to country as well,so we are not talking about
legal requirements.
For example, here in the UKright now I'm in London there is
a new regulation that is, pointof care and modular
manufacturing, where there isgoing to be a control site that

(01:38:32):
is going to control differentmanufacturing sites, but the
manufacturing sites are notgoing to be inspected by
regulatory authorities.
So this is new.
I think many countries aregoing to get something similar.
I think many countries aregoing to get something similar.
We are involved in the qualityinnovation group from the
European agency and they arethinking about doing something

(01:38:52):
similar.
We have discussions with the FDAin the emerging technology
program and I remember in 2022,the FDA organized a webinar
about this distributedmanufacturing.
I think in Europe it's calleddecentralized manufacturing, in
the US it's distributedmanufacturing.

(01:39:14):
So the regulation is going tochange.
We don't need a change in theregulation if we go through
compounding.
So that's why we are using 3Dprinting in hospitals and
pharmacies and it's totallylegal.
But if we want to move intosomething better that adds
additional layers of quality forthe patients, I think what

(01:39:47):
Thomas is doing, and the USP aswell, because we have
conversations with the USP fornew monographs.
Potentially is going to be veryimportant, because for us the
aim is not just to implement thetechnologies to prove that it's
safer, faster, cheaper, better,better, definitely.

Speaker 1 (01:39:59):
Anyone else has input on that?
Oh, if I can, just yeah, sorry,let's go here.

Speaker 4 (01:40:06):
Okay, yeah, yeah, I mean mean I agree with alvaro
there.
Uh, for the compounding part,you know it's it's pretty clear.
Of course you know it doesn'ttake away the regulatory
discussions in each region.
They are, you know theregulators approach them a
little bit different.
They want, they want tounderstand, but the compounding
sort of space is pretty defined.

(01:40:27):
Whether it's a border pharmacyin the US, in a specific state,
that you know takes a standpoint.
You typically, when they seesomething, they understand that
you know this elevates thequality of compounding, you know
, to a better level as it is,you know.
So that's one part and samegoes with Europe.
Then, yeah, of course you know,with the industrial sort of

(01:40:48):
part, and then the point of care, personalized medicine
manufacturer, where you starthaving sort of flexible dosing,
maybe authorized drugs withflexible dosing it's going to.
You know that needs guidanceand thinking and we need to work

(01:41:10):
together on that part.

Speaker 1 (01:41:16):
Okay.
Well, what's your number onechallenge at the moment at
BigLoss?

Speaker 4 (01:41:24):
Well, if we take a practical challenge for the
company, I think we are in aphase where we are.
You know there's growinginterest.
It's more like a scale up issuethat you know we can grow in a

(01:41:45):
meaningful way and then, ofcourse, get on board the other
people that are not theinnovators.
So I think we still need towork with establishing the use
cases.
And then there's growth.
Then we unfortunately strugglewith the.

(01:42:06):
Obviously we would like to haveall these spectroscopic tools
implemented with all the, allthe drugs and you know.
But it's of course a nightmareto if we have a hundred
formulations in the, in the, inthe library and and to have that
multivariate model foreverything.
It's obviously almostimpossible to do.
So we can't.

(01:42:26):
You know we can't tackle thateasily.

Speaker 1 (01:42:30):
So money or people?
Which one, which one do youneed most at the moment?

Speaker 4 (01:42:37):
Probably time Time If you would want to do that, well
, of course, money and peoplewould do that.

Speaker 1 (01:42:46):
Good answer, Sehen.
What about you?
What's your number onechallenge right now?

Speaker 3 (01:42:50):
Yeah, really I think it's really similar to what
Nicholas mentioned, right?
So number one challenge isreally how do we convert those
who are really interested?
They heard about 3D printing.
How do we convert them to be auser of this 3D printing
technology?
They all have their ownconcerns.
Some concerns are in terms ofmoney how much investment do
they have to make?
Some concerns about how is itgoing to make money after that,

(01:43:13):
how are they going to learn touse the machine, so and so forth
.
So a lot of things that we dois really to try to reduce those
barriers and we are seeing someincreasing update, but really I
think the work for us to do isstill a lot ahead.
So hopefully, with all thiswebinar series that you have
hosted, we can get moreconversion of these people who

(01:43:36):
are interested into the endusers of our technology.

Speaker 1 (01:43:40):
Yeah, I think it's not just innovation within 3D
printing itself, but alsoinnovation in economics how to
be creative in business and I'veseen so many creativity today.
So thank you so much forsharing how you are
participating in this revolution, and I do think that the space
is growing simultaneously withmany other industries, like

(01:44:02):
compound medicine itself isactually a growing industry
itself, so hopefully the marketis growing.
I don't think it's a zero sumgame, even though I know some of
you guys may be competing forthe same market, but I think the
pie is big.
It's big enough for everybody,and now it's just time to
penetrate the market.
That is the challenge.

(01:44:23):
So thank you so much forspending time with us today
Great.
I'm sorry we can't addressevery single question, but you
can always reach out to ourspeaker.
I have linked them on ourwebsite in terms of, you know,
communication.
Their linkedin profile islinked, so if you want to
message them, feel free to do so.
This is on demand after the endof this, so feel free to share

(01:44:45):
the link.
It's going to be on our Zoomaccount for a couple of weeks,
so thank you so much everybodyfor joining us and hope to see
you soon again.

Speaker 2 (01:44:56):
Thank you.

Speaker 3 (01:44:57):
See you around.

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Episode #91 | 3D Printed Pharmaceuticals (Virtual Event Recording)

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.css-14f5ked{margin:0;word-break:break-word;display:-webkit-box;-webkit-box-orient:vertical;box-orient:vertical;-webkit-line-clamp:2;overflow:hidden;}Episode #91 | 3D Printed Pharmaceuticals (Virtual Event Recording)