Episode: 13 - Engineering AAV That Can Scale

Susan D'Costa talks with Dr. David Schaefer about what gene therapy manufacturing has truly improved and where AAV vector production still breaks at scale. They connect capsid engineering, QC-friendly analytics, AI-driven directed evolution, and today’s global biotech competition into one practical view of clinical translation. Listen in for: • why viral vector production strains cell viability and limits throughput • how AAV manufacturing evolved from roller bottles and ultracentrifugation to suspension bioreactors and chromatography • how to reduce bespoke downstream work by selecting for manufacturability early • which analytical methods become painful in QC and why neutralizing antibody assays are often bespoke • why local delivery can reduce immune risk and off-target liver exposure • what China’s growing role means for innovation, deals, and competitiveness Please subscribe to the podcast and give us a rating. It helps other people find and join the conversation. If you've got speaker or topic ideas, we'd love to hear those too. You can send them in a podcast review.Host Links Susan D'Costa: https://www.linkedin.com/in/susan-d-costa-8877063 Genezen: https://www.linkedin.com/company/genezen-laboratories/ Guest Links David Schaffer: https://chemistry.berkeley.edu/people/david-schaffer Bioprocessing Unfiltered: Covering both upstream and downstream processing, analytics, AI and digitization, cell and gene therapy and more, Bioprocessing Unfiltered is your insider’s pass to the researchers tackling—and solving—the day-to-day challenges in the bioprocessing industry. 

In the latest episode of Bioprocessing Unfiltered, Bill Whitford talks with Todd Przybycien about using precipitation as a continuous capture step for monoclonal antibody downstream processing, and why higher titers make the approach practical again. We dig into step change improvements in cost of goods, throughput, footprint, and sustainability, plus what it takes to control and automate a continuous process. Join us to hear:  • Todd’s early downstream processing work and why “unconventional separations” matter • Why precipitation was sidelined at low titers and why modern mAb titers change the efficiency • How precipitation enables fully continuous capture and pairs with flow-through polishing • Where the biggest gains show up, including dollars per gram, water usage per gram, and smaller facilities  Please subscribe to the podcast and give us a rating. It helps other people find and join the conversation. If you've got speaker or topic ideas, we'd love to hear those too. You can send them in a podcast review.  Covering both upstream and downstream processing, analytics, AI and digitization, cell and gene therapy and more, Bioprocessing Unfiltered is your insider's pass to the researchers tackling—and solving—the day-to-day challenges in the bioprocessing industry. LINKS https://www.bioprocessingsummit.com/  https://www.linkedin.com/groups/1982319/ Host Links Bill Whitford: https://www.linkedin.com/in/william-whitford-00096612 Bioprocessing Unfiltered: Covering both upstream and downstream processing, analytics, AI and digitization, cell and gene therapy and more, Bioprocessing Unfiltered is your insider’s pass to the researchers tackling—and solving—the day-to-day challenges in the bioprocessing industry. 

Quality leaders are increasingly tasked with deciding where and how AI can add value without compromising quality. In this episode, Anthony Mire-Sluis, Ph.D., senior vice president of global quality at Gilead Sciences, and host Ran Zheng discuss navigating the intersection of quality, digital transformation, and AI in biopharmaceutical manufacturing. They explore how leaders can determine whether a process is ready for digitalization, avoid common implementation mistakes, and distinguish between AI that supports quality decisions and AI that makes them. Mire-Sluis also explains what meaningful human oversight looks like, how AI could help prevent human error and strengthen quality systems, and how digital transformation may reshape roles for operators, analysts, and quality professionals. Links from this episode:  Bioprocessing Summit Gilead Sciences Bioprocessing Unfiltered: Covering both upstream and downstream processing, analytics, AI and digitization, cell and gene therapy and more, Bioprocessing Unfiltered is your insider’s pass to the researchers tackling—and solving—the day-to-day challenges in the bioprocessing industry. 

Everyone wants smarter bioprocessing, yet most teams are still fighting the same battle they fought years ago: inconsistent information, messy process data, and systems that were never designed to support analysis. At this year's Bioprocessing Summit Europe, industry experts gathered on a panel to address these gaps, explore why data challenges persist, and discuss why the hardest part is often data engineering and harmonization. Moderated by Maximilian Krippl, Ph.D., head of bioprocess modeling consulting at Novasign, the panel consisted of Andrea Arsiccio, Ph.D., senior scientist and team lead in silico at Coriolis Pharma; Ayca Cetinkaya, Ph.D., senior scientist at AstraZeneca; Mario P. Pereira, Ph.D., director of technology and business development at ATUM; and Jack Prior, Ph.D., head of process monitoring and data science and AI strategy at Sanofi. Their discussion also explores strategies to transform raw information into actionable insight and practical guidance to make data comparable and usable. Links from this episode:  Bioprocessing Summit Bioprocessing Summit Europe Novasign Coriolis Pharma AstraZeneca ATUM Sanofi Bioprocessing Unfiltered: Covering both upstream and downstream processing, analytics, AI and digitization, cell and gene therapy and more, Bioprocessing Unfiltered is your insider’s pass to the researchers tackling—and solving—the day-to-day challenges in the bioprocessing industry. 

In this episode of Bioprocessing Unfiltered, Jack Scarcelli, senior director and head of cell line development at Sanofi, speaks with host Hussain Dahodwala, professor of upstream process development at University of Maryland’s Institute of Bioscience and Biotechnology Research, to discuss technical and strategic challenges in the next gen cell line development in the biopharmaceutical industry. Scarcelli traces his career journey, shares lessons learned over a successful career, and offers thoughtful advice for early career scientists. Plus, some highlights from the upcoming Bioprocessing Summit in Boston in August and hope for collaboration to shape the future.  Links from this episode:  Bioprocessing Summit Sanofi  Bioprocessing Unfiltered: Covering both upstream and downstream processing, analytics, AI and digitization, cell and gene therapy and more, Bioprocessing Unfiltered is your insider’s pass to the researchers tackling—and solving—the day-to-day challenges in the bioprocessing industry. 

In this episode of Bioprocessing Unfiltered, Jack Prior, head of process monitoring and data science and AI strategy at Sanofi, explores how AI has evolved from early expert systems to machine learning, generative AI, and agentic AI, and what that means for biomanufacturing today. He explains why digital transformation has not automatically created usable data, and why the real challenge is turning fragmented information from manufacturing systems into accessible, authentic, and analysis-ready data. Jack shares a practical framework for assessing data maturity and argues that the biggest near-term opportunity for AI is reducing friction in data engineering, troubleshooting, tech transfer, and decision support across bioprocessing organizations. Links from this episode:  Bioprocessing Summit Sanofi   Bioprocessing Unfiltered: Covering both upstream and downstream processing, analytics, AI and digitization, cell and gene therapy and more, Bioprocessing Unfiltered is your insider’s pass to the researchers tackling—and solving—the day-to-day challenges in the bioprocessing industry. 

Anurag Rathore, professor of chemical engineering at the Indian Institute of Technology Delhi, joins Bioprocessing Unfiltered with host Alois Jungbauer to discuss his long career in advancing bioprocessing engineering. Rathore shares his thoughts on chromatography, using platform processes to accelerate process development, how infinity capture can be a way to arrive at platform processes, and if there is a need for alternative methods. He also explores updates needed to the traditional curriculum of biochemical engineering—and if the next generation should know how to use AI and ML—and his view on bioprocess and development. Links from this episode:  Bioprocessing Summit Indian Institute of Technology Delhi Bioprocessing Unfiltered: Covering both upstream and downstream processing, analytics, AI and digitization, cell and gene therapy and more, Bioprocessing Unfiltered is your insider’s pass to the researchers tackling—and solving—the day-to-day challenges in the bioprocessing industry. 

At the most recent Bioprocessing Summit, David Y. H. Chang, CEO of Taiwan Bio-Manufacturing Company; Bo Wiinberg, Chief Business Development Officer of Novo Nordisk Foundation Cellerator; and Paul Lewus, Vice President of Site Operations at Amgen gathered for a fireside chat moderated by Ran Zheng, former CEO of Landmark Bio, to discuss the technologies and innovations shaping the future of biomanufacturing. The conversation explored upcoming trends, investment opportunities, and modalities into the next decade, as well as the question: how should the industry best prepare for all of it? Links from this episode:  Bioprocessing Summit Landmark Bio Novo Nordisk Foundation Cellerator Taiwan Bio-Manufacturing Company (TBMC) Amgen  Bioprocessing Unfiltered: Covering both upstream and downstream processing, analytics, AI and digitization, cell and gene therapy and more, Bioprocessing Unfiltered is your insider’s pass to the researchers tackling—and solving—the day-to-day challenges in the bioprocessing industry. 

Picking up from their previous conversation on Bioprocessing Unfiltered, Andrew Sinclair, president and founder of BioPharm Services Ltd., and host William Whitford, founder of Oamaru BioSystems, discuss improving manufacturing efficiency, including process mass intensity and setting up parameters, and more on Sinclair’s long career and valuable experiences in the industry. Sinclair also shares advice on helping someone who cannot meet parameters, how to navigate new profusions, and default values that can help others with their processes. Links from this episode:  Bioprocessing Summit  Biopharm Services  Bioprocessing Unfiltered: Covering both upstream and downstream processing, analytics, AI and digitization, cell and gene therapy and more, Bioprocessing Unfiltered is your insider’s pass to the researchers tackling—and solving—the day-to-day challenges in the bioprocessing industry. 

How can we optimize manufacturing and operations? In this episode of Bioprocessing Unfiltered, Andrew Sinclair, president and founder of Biopharm Services, provides insight from his 35-year-long career in the industry on the most significant ways data management and predictive modeling can improve efficiency during the manufacturing process. With host William Whitford, founder of Oamaru BioSystems, Sinclair delves into the history and impact of costs, how to handle evolving efficiencies, and why understanding definitions can be useful for speaking the language of regulators and rating organizations. Links from this episode: Bioprocessing SummitBiopharm Services Bioprocessing Unfiltered: Covering both upstream and downstream processing, analytics, AI and digitization, cell and gene therapy and more, Bioprocessing Unfiltered is your insider’s pass to the researchers tackling—and solving—the day-to-day challenges in the bioprocessing industry.