PRE-CONFERENCE WORKSHOP DAY - TUESDAY DECEMBER 14, 2021
Regulatory Deep Dive into Effective Potency Testing
9am - 12pm EST
Achieving regulatory approval on potency assays is a huge issue for the cell therapy space with many submissions being rejected due to the not hitting the standards for the complex product needs.
This group discussion will take a deep dive into the following:
• Overcoming hurdles to potency assay changes from early through to late-stage clinical development
• Long term program management for potency assays
• How to shape your potency assay strategy in accordance with lot release schedule, product availability and regulatory feedback
• Standardizing these processes to be sustainable in a commercial market
Head of Biologics Analytical Development & Characterization, Therapeutic Discovery
MD Anderson Cancer Center
Chief Technology Officer
Lunchtime Refreshments & Networking 12-1pm EST
Process Automation to Speed Up Turnaround Time for Release and Meet Patients Needs
1pm - 4pm EST
Manufacturing timelines are the greatest rate-limiting step in cell therapy drug development, but when drilling deeper it is in fact the release timelines in analytical development that is the critical bottleneck in the vein-to-vein delivery of autologous cell therapies.
Join this collaborative session to discuss:
• Outline the need to shorten the process for critical analytical tests
• Review current safety tests which provide a bottleneck to timeline, meeting the balance of ensuring safety but also providing the product to the patients as soon as possible?
• Accelerate testing by increasing the sensitivity of the assay to shorten timelines, design a better matrix to determine the results sooner
• Reduce human error and variation through automation, and discuss the growing need for automation due to scale up across multiple sites and products