Product Stability and Storage: What Do I Really Have to Do?
Program Code: 9130-QE-CT
Saturday, October 24, 2009
4:00 PM to 5:30 PM (ET)

MODERATOR
Doug Padley, MT(ASCP), Mayo Clinic

SPEAKERS
John D. McMannis, Ph.D., The University of Texas MD Anderson Cancer Center
Doug Padley, MT(ASCP), Mayo Clinic
Donna Regan, MT(ASCP)SBB, St. Louis Cord Blood Bank

DESCRIPTION
Stability programs are required for cellular therapy products; they are the basis for determining expiration dates.
This program will describe the regulatory requirements for stability programs for different types of products (351, 361, licensed) in addition to presenting factors to consider when developing a stability program. Beyond the regulations, product storage can present a challenge to the cellular therapy laboratory. Is there a preferred method for overnight storage of HPC, apheresis products? How do you know that the product frozen 10 years ago is suitable for transplant? How can you be assured that a cellular therapy product made under IND is stable for the duration of a clinical trial? These and other complexities of product storage will be discussed.