The rapidly growing number of cell therapies entering and progressing through the clinic is translating to increased regulatory requirements for raw materials. The quality, consistency, and safety of raw materials of biological origin (e.g. cells, serum, growth factors, cytokines, antibodies, and enzymes) must all be documented and available for regulatory review, particularly at the BLA stage.
This webinar will explore the specific regulatory requirements of different regions (including analysis of the amount of time the regulatory approval process takes in each case), and improve attendees’ understanding of the critical quality attributes (CQAs) of cell therapy raw and starting materials. The importance of a risk-based approach to raw material sourcing will be emphasized, as will the importance of harmonization and standardization of processes and protocols in cell therapy.
Attendees will grow their understanding of: