Workshop A

Standards, Tools and Fit-for-Purpose Approaches to Improve Confidence in Viability Measurements for Cell Therapy Products

10:00am - 12:00pm EST | 6am - 9am PST

Determining the cell count of a cell therapy product is essential to understanding the product attributes. However, there are inherent challenges in attaining consistency from count to count, which must be overcome to improve count and liability measurements. There is a need to address the issue of overestimation of live cells with current viability assays to determine which instruments should be used.

This workshop will:

• Describe tools and techniques to identify and mitigate sources of variability in cell viability assays
• Identify needs and gaps for cell viability standards and share current standardization efforts
• Consider approaches for developing fit for-purpose viability assays that address different aspects of cell health

Laura Pierce

Laura Pierce
Biomedical Engineer
National Institute of Standards and Technology

Workshop B

Developing a Rapid Release Platform for Autologous CAR-T Phase I/II Products

1pm - 3pm EST | 10am - 12pm PST

Despite the exciting success of cell-based therapies, there are unique challenges that must still be addressed, such as how to reduce the time it takes for release testing to occur, to reduce vein-to-vein time, and ensure that critically ill patients receive safe and effective treatment quickly.

This workshop will discuss:
• Challenges and opportunities for assay development and qualification
• A case study: SJCAR19 clinical protocol release testing development
• Lessons learned and platform improvements

Catherine Willis

Catherine Willis
Quality Control Manager, Children’s GMP
LLC. / St. Jude Children’s Research Hospital