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Navigating the regulatory requirements to commercialize your cell therapy

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Webinar Presenters:

Speaker photo Jiwen Zhang
Regulatory Affairs Director,
GE Healthcare Life Sciences

Speaker Bio

Speaker photo Ray Ismail
Senior Scientist,
GE Healthcare Life Sciences

Speaker Bio

Webinar Abstract
For regulatory review and approval, cell therapy products are required to meet quality standards, and submit Chemistry, Manufacturing, and Control (CMC) information to the Regulatory Authorities. Furthermore, Good Manufacturing Practice (GMP) is mandated by national laws and regulations to ensure product quality. Due to evolving science and unique properties of cell or tissue based products, GMP development and production for these products have been challenging, especially in clearly defining the quality attributes, - safety, identity, purity, stability, potency/biological activity, and in defining what tools to use to achieve these quality attributes.

In this Webinar:
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  • Learn what to consider when selecting appropriate tools for GMP manufacturing of cell therapy products
  • Learn how documentation of GMP manufacturing tools, such as the Drug Master File (DMF) can support regulatory CMC review and approval.
  • Hear how the design features of the Xuri™ Cell Expansion System W25 address the biosafety and performance regulatory requirements for cell therapy products.