GMP ancillary materials for cell and gene therapy manufacturing: what to consider and when to make the switch
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.
Kasey Kime has 10 years of Life Science quality and regulatory affairs experience. Her areas of expertise include raw material risk assessment for biopharmaceutical applications with a particular focus on cell and gene therapy customer and regulatory requirements. Kasey has been working at Thermo Fisher Regulatory Affairs for the last 7 years and is a core team member for new products developed for cell and gene therapy applications. Kasey holds a Bachelor's Degree in Medical Laboratory Science from Auckland University of Technology and holds post graduate degrees in science and quality systems.