GMP Ancillary Materials for Cell and Gene Therapy Manufacturing: What to consider and when to make the switch

Sponsored by: Thermo Fisher Scientific/Gibco

Speakers

Kasey Kime

Manager, Regulatory Affairs, Clinical and Compliance - Thermo Fisher Scientific
BIOGRAPHY
Eric J. Roos

Global Strategic Alliances Leader, Cell Therapy, Life Sciences Solutions Group - Thermo Fisher Scientific
BIOGRAPHY

Abstract

Register now for live event or to view the webinar on demand if you cannot make the live time.

DATE: October 9, 2018

TIME: 08:00am PDT, 11:00pm EDT

Have you ever wondered what to consider when you are selecting ancillary materials for your cell therapy clinical research? This webinar will cover regulatory requirements for GMP ancillary materials and the importance of regulatory documentation and support to enable successful clinical translation. As you move through clinical trials toward commercialization you’ll need solutions that can scale with you to meet the clinical need. The second part of this session, will address aspects you should consider now such as scalability, consistency of supply and commercial use rights to help clear your path to commercial manufacturing in the future.

Learning Objectives:

Regulatory requirements for GMP ancillary materials for cell and gene therapy
The importance of regulatory documentation and vendor support to enable successful clinical translation
How planning for commercial use considerations early can clear your path to the clinic and future commercial manufacturing

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