Qualification of raw materials used in the manufacturing of cellular therapies requires the use of risk assessment strategies to categorize the critical components of a manufacturing process. In addition to cell culture supplements, excipients and other formulation’s components must meet the required quality to ensure consistency in manufacturing and subsequently the quality and safety of finished cell therapy products. This presentation will discuss the critical challenges facing the development of cell therapies, and the type of qualification programs to help ensure consistency in the manufacturing of cell and gene therapies.

Includes English subtitles

Subject area:
Biologics

Objectives (If applicable):
– Demonstrate the challenges facing developers of processes for manufacturing cell therapies
– Identify existing USP standards for raw materials
– Develop internal processes for the qualification of raw materials.

Target Audience (If applicable):
Individuals involved in the development of cell and gene therapies from QA/QC, Process Development, Manufacturing and Regulatory professionals