This panel discussion was originally published in the eBook “ Monoclonal Antibody Manufacturing Trends, Challenges, and Analytical Solutions to Eliminate Bioprocessing Bottlenecks” You can download all the articles in the series, by downloading the eBook.   Panel discussion members: Carrie Mason - Associate Director, R&D at Lonza Biologics Laura Madia - Independent Industry Consultant Alan Opper – Director of HaLCon Sales at RedShiftBio David Sloan, PhD – Senior...

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 process and that traditionally buffers were made in large tanks,...

In this podcast, we spoke with Margherita Neri, Director of Vector Process Development, Milan Site at AGC Biologics, Andrew Laskowski, Global Product Manager Bioreactors at Cytiva and Andreia Pedregal, Upstream Applications Specialist Manager at Cytiva about large-scale viral vector manufacturing. Our conversation included discussions around scalability, AAV (adeno-associated virus) and lentivirus production platforms, adherent culture, and next generation bioreactor improvements. I began...

In this podcast, we talked with Dr. Ma Sha, Head of Bioprocess Applications at Eppendorf SE about advancements and challenges in cell and gene therapy production along with solutions for scale up and transition to stirred-tank bioreactor suspension culture. We began the interview by talking about the biggest advancements in cell and gene therapy, including CAR T-cell therapy development, clinical results and FDA approvals. Another area of great advancement is induced Pluripotent Stem Cell...

In this podcast, we talked with Nathalie Dubois-Stringfellow, Senior Vice President of Product Development and Management at Sangamo about Sangamo’s work in gene therapy and the latest data on Sangamo’s gene therapy product candidate for Fabry disease. I began the interview by asking Nathalie if she could talk about Sangamo and the company’s pipeline. She explained that Sangamo is a genomic medicine company dedicated to translating groundbreaking science into medicine. Their technology...

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 to replace stainless steel vessels within the manufacturing...

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 saying that as a bioprocess product specialist, he performs...

In this podcast, we spoke with Cory Hinz, Engineering Manager at Asahi Kasei Bioprocess 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. Liquid Chromatography Mobile Phase Solutions I began the discussion by asking Cory if he could tell listeners about the different methods that are...

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 quality management. Katie replied by saying that a holistic...

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 challenges in this area. Klaus explained that mixing is an...

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 for patients I began the discussion by asking why high...

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 Shortages I began the discussion by asking our panel members if...

This article was originally published in the eBook “ Future proofing Bioprocessing from Upstream to Downstream”. You can download all the articles in the series, by downloading the eBook. Not everyone has the luxury of building from the ground up. How do you create a unified system between upstream and downstream with existing equipment and processes? And if you have the ability to build from the ground up, how can you ensure that your design is future proof? We spoke with Phil Sanders,...

In this podcast, we spoke with Dr. Brad Taylor from Nucleus Biologics and Randy Jacinto from Cytiva about the benefits of using a custom media for cell and gene therapy process development. Topics included current development challenges, increases in the number of cell and gene therapies in clinical trials, and employing custom cell culture media solutions to address these issues. We started the discussion by talking about the most pressing challenges facing cell and gene therapy...

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 potential of these personalized therapies is becoming more...

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...

In this podcast, we talked with Parth Trivedi, Business Development Manager, Pall Corporation, about the importance of implementing a Quality by Design strategy for AAV product manufacturing and specific key steps for successful assessment. We began by talking about the importance of Quality by Design (QbD) in AAV product manufacture and how this pertains to the regulatory landscape. Parth explained that there have been several recent regulatory approvals of gene therapy products, but in...

In this podcast, I talked with Dr. Jimmy Li, CEO of WuXi XDC, a WuXi Biologics subsidiary. We discussed the reasons for the formation of WuXi XDC, which was established via a joint venture between WuXi Biologics and WuXi STA, a WuXi AppTec subsidiary, and how one-stop drug development organizations greatly streamline a pathway to the clinic. He also shares new technologies available to make the development of Antibody Drug Conjugates (ADCs) more efficient and effective. 

In this podcast, I talked with Dr. Jimmy Li, CEO of WuXi XDC, a WuXi Biologics subsidiary. We discussed the reasons for the formation of WuXi XDC, which was established via a joint venture between WuXi Biologics and WuXi STA, a WuXi AppTec subsidiary, and how this company provides a true single-source for the discovery, development, and GMP manufacture of antibody drug conjugates and other novel bioconjugates with their highly efficient one-stop drug development platform.

In this podcast, we talked with Dr. Alison Porter, Head of Expression System Sciences, Lonza, about the use of stable pool expression to reduce drug development timelines. Highlights included the implementation of stable pools in current workflows, expected titers, and cutting-edge applications of the technology.

Phil Sanders talks about the increase in demand for single-use equipment and consumables and how this has led to supply chain shortages.

Several of the most promising candidates in the pipeline use mesenchymal stromal cells and pluripotent stem cells, both of which require an adherent substrate for native biological function. Thus, utilizing an adherent platform for production of these cell types provides several advantages, including shorter process development and optimization time, no need to adapt cells to suspension, and the ability to implement various surface modifications that promote the relevant biology.

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 approaches.

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.