Release Testing for Cell Therapy Products
Program Code: 129-S
Saturday, October 23, 2004
4:00 PM to 5:30 PM (ET)

SPEAKERS
John D. McMannis, Ph.D., The University of Texas MD Anderson Cancer Center
Elizabeth Read, MD, University of California, San Francisco
Gary DuMoulin, PhD, MPH, Genzyme BioSurgery

DESCRIPTION
This session provides an overview of release testing requirements for a wide range of cell therapy products based on product type and intended use. Discussion will include rapid release tests, which are critical for many cell therapy products with limited shelf lives. Special emphasis will be placed on the challenges associated with sterility testing for cell therapy products.

OBJECTIVES

• Discuss release testing for cell therapy products with consideration for the phase of the the clinical trial and/or the category of the product (351 versus 361 versus gene therapy)
• Describe the components of a Product Specification
• Describe rapid release assays for cell therapy products
• Discuss the issues associated with sterility testing for cell therapy products

AUDIENCE
Physicians, Scientists, Technologists, Managers/Supervisors

PROGRAM LEVEL
Intermediate to Advanced