Using End-to-End Integrated Solutions to meet the High Demand for Viral Vector GMP Manufacturing

In this podcast, I spoke with Hanna Lesch Ph.D., Chief Technology Officer at Exothera about viral vector manufacturing. We discussed current industry needs and challenges, scalability, end to end solutions, and key insights to a successful manufacturing and approval process. I began the discussion by asking Hanna about the viral vector manufacturing that she is working on at Exothera. She explained that Exothera is a Belgium-based CDMO delivering customized process development and GMP manufacturing services for gene therapy and viral vector-based vaccines. In 18 months, they built their new facilities with a GMP qualified manufacturing area of 2100 square meters. They have flexible manufacturing solutions for adherent or suspension scale and can accommodate small to large scale manufacturing up to 2000 L. Next, I asked if she could share her thoughts on current industry needs in terms of commercial scale production of viral vectors. She said that Exothera was founded to tackle two of the most critical challenges that manufacturers face in bringing advanced therapies to market – lack of production capacity and a shortage of bioprocessing expertise. Another area of focus is on cost of goods, as the cost of manufacturing a gene therapy product is significantly higher compared to conventional products. To reach as many patients as possible these treatments will need to be significantly less expensive. To succeed in this, Hanna believes that the industry needs to overcome several challenges, including development of standardized processes, consistent product quality, and improving manufacturing yields. She added that today there are also major time constraint risks because of delays in raw materials or consumable supply. We then discussed scalability and how Exothera manages their scale up needs. Hanna described how Exothera provides access to platforms, technical know-how and facilities to speed clients’ product development time. She said that Exothera has built their capability to serve process development from their parameter screening supported by design of experiments (DOEs), small scale bioreactors for process development, middle scale for process confirmation and large scale systems to meet high yield expectations. All available in both suspension and adherent cell culture. She stated that it is key to be able to provide the full path for the product lifecycle. Then, I asked her how integrated end-to-end solutions can benefit viral vector manufacturing. She explained that end-to-end solutions can provide a fast track to clinic for their clients. This is supported by a strong technical, analytical and bioprocess know-how. These solutions also minimize the potential risks and surprises during development, providing lower cost and better predictability. She shared an example where they started a collaboration project aiming for quick AAV process scale-up into a 2000 Liter bioreactor in a very short time frame. Working with end-to-end providers, like Pall Corporation, is key to helping Exothera implement new technologies and infrastructure very quickly. She emphasized that time is money. I then followed up and asked what advice she had for others who need scale up solutions. Hanna shared that making critical decisions about the manufacturing process carefully is important, as this can drastically increase the chances of succeeding the first time. Second, select an easily scalable technology. Last, know your viral construct to avoid any surprises later and ensure regulatory compliance and a solid testing strategy for both your product and your process to achieve a straightforward approval. I closed the interview by asking Hanna if she had anything else to add for listeners. She said that if you don’t have a manufacturing platform ready, it is important to find the right partner who can support your development and your manufacturing success. She also told me that she has an upcoming webinar,