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.