Broadcast Date: July 15, 2022
Time: 8:00 am PT, 11:00 am ET, 17:00 CET

The biopharma industry is operating at lightning speed, where new therapies and treatments are being developed and manufactured faster than at any other time in our history. This acceleration is shining a light on the need for innovative technologies that will help developers and producers maintain quality in these burgeoning new products. There is a need to balance efficient manufacturing with the goal of ensuring product quality and consistency while minimizing batch out-of-specification and failure events. Regulators are increasingly encouraging the adoption of real-time production analytics that will inform and help optimize key production processes and potency assays. Advanced analytics will enhance both the quality and consistency of the products, ensuring the growing demand for these highly complex cell & gene, and vaccine biologics are met, with the potential to deliver the holy grail of biomanufacturing: real-time release assays.

In this GEN webinar, our distinguished speaker, Dr. Peter Marks, MD, PhD, will discuss the growing need for advanced manufacturing technologies and methods that will give rise to more precise and accurate analytics. Moreover, he will provide additional insights from a regulator’s perspective on the need for improved manufacturing process monitoring capabilities to boost product consistency. Lastly, James Robinson, former Vice-Chair of the CEPI Scientific Advisory Committee and a 35-year veteran in biomanufacturing, will share industry case studies that highlight how real-time single-cell analytics can significantly improve production outcomes and quality.

 

A live Q&A will follow the presentation, offering you a chance to pose questions to our expert panelists.

Peter Marks, MD, PhD
Director of the Center for
Biologics Evaluation and Research
U.S. Food and Drug Administration
James Robinson
James Robinson
Former Vice Chair, CEPI Scientific Advisory Committee
LumaCyte Scientific Advisory Board

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