The Downstream Column Podcast

The Downstream Column Podcast

The Downstream Column (DsC) is an online publication targeting members of the biologics industry. Our intent is to provide a community to share expertise and best practices as well as discuss topics of interest. The Downstream Column covers areas important to the research, discovery, development, and manufacture of biologic therapeutics. Key industry coverage areas include: purification, formulation, fill/finish and QA/QC for cell and gene therapies, vaccines, biologics, and emerging therapeutic modalities.

Episodes

Advancements in Buffer Management and Single Use Inline Buffer Formulation

February 23, 2024 • 15 mins
In this podcast, we spoke with Nainesh Shah, Senior Application Engineer at Asahi Kasei Bioprocess about buffer management including the benefits of inline buffer formulation, and single use inline buffer formulation systems.   Buffer Management  We started the podcast by talking about how critical buffer management is to bioprocessing. Mr. Shah discussed how buffers are required in large quantities during the biomanufacturing proc...
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New online Gene Therapy Academy offers great resources to support scaling up from lab to production scale

October 5, 2022 • 13 mins
In this podcast, we spoke with Emanuel Krobath, Biopurification Specialist and Chiara Pacini, Bioprocess Specialist both with Pall Corporation about gene therapy process development including challenges and resources that are available for support.   I began the discussion by asking Emanuel and Chiara to tell listeners a little bit more about their jobs and how they support gene therapy developers on the bench. Emanuel started by ...
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A Guide for Navigating the Single Use Technology Supply Chain

September 20, 2022 • 34 mins
In this podcast we spoke with Derrick Alig, North American Western Regional Sales Manager for PSG Dover Biotech, Chris Couper, President and Founder of Liquidyne Process Technologies, and Phil Sanders Biotech Chief Innovation Officer at Agilitech about current supply chain challenges, possible solutions, what the future holds, and ways to navigate supply chain shortages to ensure manufacturers meet their timelines. Supply Chain Sho...
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Manufacturing high concentration mAbs challenges and solutions

August 25, 2022 • 15 mins
In this podcast, we spoke to Tom Watson, Group Leader, Product Management – Biotech Division, Gregor Kalinowski, Manager SLS Purification Consultants Europe, and Aude Iwaniec, R&D Bioprocessing Team Leader, all from Pall Corporation, about why high concentration mAbs are an increasingly important part of the biotech landscape, current manufacturing challenges and solutions, and future trends. High concentration drugs offer benefits...
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Biomanufacturing Quality Management Systems – A holistic approach

August 11, 2022
In this podcast, we interviewed Katie Keller, Director of Quality and Safety at Asahi Kasei Bioprocess America, about the importance of quality management and how to achieve the best possible results. Topics included the most critical elements of quality management, how to ensure the purchase of high-quality equipment, and future trends. I started the conversation by asking Katie what she thought were the most critical elements of...
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Flexible single-use mixers are key to achieving a next level mixing experience and reducing delivery lead times

July 27, 2022 • 16 mins
In this podcast we spoke with Klaus Kienle, Global Product Manager for the Mixing portfolio at Pall Corporation about the latest mixing technologies including single-use solutions, the need for increased flexibility, and a more standard vendor agnostic approach. The Role of Mixing in Biomanufacturing I started the conversation by asking Klaus if he could talk about the role that mixing plays in biomanufacturing and current challen...
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Optimizing Process Development Early – A critical factor in successful viral vector scale up and large scale manufacture

July 12, 2022 • 13 mins
In this podcast, I spoke with John Ketz and Denis Kole about viral vector production, including current manufacturing challenges, navigating the road to commercialization, and successful scale up strategies. We began the interview by discussing the strides made in cell and gene therapy. Denis shared information about the several  approved therapies and the more than 2,000 ongoing clinical trials. Denis added that while the immense...
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Single-use Mixers – Ensuring the Customization, Scalability and Supply Required for Success

May 25, 2022 • 10 mins
In this podcast, we talked with Dennis Hodgson and Phil Sanders from Agilitech about the benefits of single-use mixers, dealing with supply chain concerns, ensuring scalability, and tailoring a mixer to meet specific process needs. Benefits of Single-use Mixers We began the podcast by talking about the overall benefits of single-use technologies for mixing. Dennis explained that single-use mixers are very versatile and can be used ...
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Increasing Liquid Chromatography Efficiency with Fully-controlled Binary Blending

May 19, 2022 • 7 mins
Cory Hinz talks about the different methods that are available for liquid chromatography mobile phase solutions and the benefits of inline blending. Cory also describes how to implement binary blending feeding of a liquid chromatography process using inline blending.
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Addressing the increasing demand for single-use technologies and supply chain shortages with future proof systems

October 28, 2021 • 16 mins
Phil Sanders talks about the increase in demand for single-use equipment and consumables and how this has led to supply chain shortages.
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Evolving Beyond the Status Quo with Next Generation Buffer Prep Solutions

August 17, 2021 • 14 mins
In this podcast, we spoke with Chris Rombach, Vice President of Sales and Marketing at Asahi Kasei Bioprocess America about buffer prep and delivery systems. We discussed current pain points and how next generation buffer prep solutions can greatly improve upon the status quo, including increasing the use of automation and remote operation, while reducing the overall footprint, labor and cost associated with more traditional approa...
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Integrated Freezing Solutions to Minimize Risk and Preserve Product Quality

April 27, 2021 • 10 mins
Claire Jarmey-Swan, Global Product Manager, Pall Corporation talks about the evolution freeze thaw technologies and how these new methods can streamline the process, minimize loss and maintain the highest product quality.
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Start With The End In Mind. How to facilitate transfer from non-GMP to GMP Manufacturing

June 28, 2018 • 14 mins
Avril Vermunt, bioprocess hardware specialist at GE healthcare talks about transferring a process from non-GMP to GMP manufacturing, particularly how resource-intensive it is for process development and manufacturing groups. Avril has several years of experience working in the technology transfer group at a large pharmaceutical company. We discussed with her best practices and how being proactive and one step ahead can make the pro...
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Modeling Downstream Disruptive Technologies to Improve Downstream Bioprocessing.

June 7, 2018 • 8 mins
Dr. Yuyi Shen, Principal Scientist, Grifols, talks about the benefits of modeling downstream disruptive technologies to improve downstream bioprocessing and evaluating the financial impact of implementing these technologies.
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Cell Harvesting – Selecting a technology compatible with cell density and feed turbidity

April 10, 2018 • 11 mins
Silke Bergheim-Pietza, Global Product Manager Depth Filtration, Pall. discusses challenges faced in the cell harvesting step, in particular, selecting the best cell harvesting method based on the cell density and feed turbidity of the process and meeting the demand of increasing cell densities. Download the cell harvesting technology selection guide and use the guide to compare the latest single-use harvesting technologies.
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Continuous Biomanufacturing Implementation Now and in The Future

March 6, 2018 • 12 mins
Dr. Peter Levison, Senior Marketing Director – Downstream Processing, Pall Biotech talks about the evolution and benefits of continuous biomanufacturing, what implementation looks like today and what still needs to be realized for full industry adoption.
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Addressing Challenges in Downstream Biomanufacturing with a Platform Purification Approach

January 31, 2018 • 16 mins
Jonathan Royce, Business Leader, Chromatography Resins, GE Healthcare Life Sciences, talks about the biggest challenges in Downstream biomanufacturing including overcoming bottlenecks, changing antibody structures and bioburden control. Jonathan shared how a purification platform can address some of these issues and discusses purification challenges that still need to be resolved.
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Protein A Chromatography – A look at where we have been and where we are going

December 12, 2017 • 25 mins
Jonathan Royce, Business Leader, Chromatography Resins, GE Healthcare Life Sciences, talks about the evolution of Protein A including the latest developments in Protein A chromatography resins. We also discussed what the future holds for this purification mainstay and how it can continue to address the changing needs of biopharma.
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Resolving Large Scale Buffer Management Challenges

November 29, 2017 • 11 mins
Joakim Lundvist, Modality Manager, BioProcess™ Hardware, GE Healthcare talks about large-scale buffer management challenges. Buffer preparation is known to be one of the most resource-intensive activities in biomanufacturing as large volumes of buffers and process liquids are often required. So how can this be done in a more efficient way? How can more capacity be added to buffer preparation without adding major capital investment?...
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Job Outlook for the Biomanufacturing Industry a Recruiter’s Perspective

April 5, 2017 • 13 mins
Hillary Kaplan, Director, Bioprocess CMC Development & Operations, Klein Hersh talks about the job outlook for the biomanufacturing industry from a recruiter’s perspective.
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