ISCT 2015 - Webinar - Viability Determination of Cellular Therapy Products
ISCT Webinar: Viability Determination of Cellular Therapy Products - The Need for Controlled Objective Analysis
Organized by the ISCT North America Legal & Regulatory Affairs Committee
- Shirley M. Bartido, PhD, MBA, Cell Therapy Consultant, Charite University Medicine Berlin, Germany
- Sumona Sarkar, PhD, Biomedical Engineer, National Institute for Standards and Technology, USA
- Andreas Boehmler, PhD, Global Marketing Manager, Beckman Coulter, USA
- Jean Qiu, PhD, Chief Technology Officer, Nexcelom Bioscience, USA
About the Webinar:
The measurement of cell content and cell viability are considered to be universal indicators that define the total and viable/nonviable cell content for any cell therapy based product. This webinar will describe the need for measurement accuracy in determining the live/dead populations for cell therapy product (CTP) development process so as to establish confidence through assay qualification and validation. Developing confidence in these measurements may reduce barriers in the regulatory process and help to establish appropriate controls during product development.
This webinar will describe the prevalent methodologies utilized and inherent deficiencies. It will describe the need and current status of alternative analytical methods that can aid in ensuring the consistency and comparability for cell viability specifications. The consideration of the selection and qualification of the proper viability assay is important in the early development process of CTPs. Its use in conjunction with purity and potency assays that are needed would ensure a quality product.
Mechanics of measurement accuracy for cell counting
Deficiencies of current methodologies utilized for CTPs
Action of alternative cell permeant dyes in live/dead methodology use by flow cytometry and other techniques
Qualification and validation of these alternative viability assays with possible semi automation
Clinical significance of these objective cell analysis of viability