ISCT- Stem Cell Product Characterization
Program Code: 5020-S(CT)
Saturday, October 21, 2006
2:00 PM to 3:30 PM (ET)

MODERATOR
Shelly Heimfeld, PhD, Fred Hutchinson Cancer Research Center

SPEAKERS
Karen J. Edward, BS, MT(ASCP), Advanced Cell and Gene Therapy
Joyce L. Frey-Vasconcells, PhD, PharmaNet

DESCRIPTION
Effective product characterization is vitally important in clinical development of any cell therapy product. Although elements of characterization follow a standard formula - safety, purity, identity, potency and stability - establishing, optimizing, and qualifying assays for these parameters can be challenging. This session will cover development and qualification of cell therapy product characterization testing, and with emphasis on strategies for addressing commonly encountered problems. Potency testing will be a particular focus, as it presents some of the greatest challenges in characterization testing. Strategies for establishing relevant biological function, assay selection and qualification, development of target specifications, and regulatory expectations and requirements will be discussed. The session will be as interactive as possible, and will draw upon questions and experiences of participants.