Stem cell therapies are beginning to enter the clinic, and their quality and safety depends on raw materials (ancillary reagents) used in their production. With the clinical phases of development of a therapeutic being highly regulated, there is an increasing requirement for cGMP (Current Good Manufacturing Practice) materials to ensure safety and suitability.
This webinar offers a discussion about GMP raw materials (ancillary reagents) for cell therapy manufacture.
- What GMP means in the context of raw materials and ancillary reagents
- Quality of raw materials required along commercialization pathways
- When to start using GMP materials
- Current regulatory landscape within cell therapy development
About the Presenters
The discussion panel is comprised of:
- Dr Sadik Kassim, Vice President, Process & Analytical Development, Mustang Bio. Inc
- Dr John Tomtishen, Manufacturing Science & Technology, Novartis
- Dr Diane Wotta, Senior Director, Quality & Regulatory Affairs, R&D Systems, a Bio-Techne Brand
The webinar is moderated by Jean Stanton, Director, Pharmaceutical Regulatory Compliance at Johnson & Johnson.