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Development of Potency Assays for Cell and Gene Therapy

Presented at: Bioprocessing 2021
C.E. Credits: P.A.C.E. CE Florida CE
Speaker
  • Scientist, Technical Operations, Sana Biotechnology
    Biography
      Nagarjun is a Scientist in Technical Operations at Sana Biotechnology (Cambridge, MA). He completed his PhD in Medical Sciences at Texas A&M University (Texas), where he worked on development of a universal lentiviral vector platform for different gene therapy applications. After his graduate school, he joined Lonza (Houston), as a research intern and worked on developing cell lines for high titer productivity of different viral vectors. Nagarjun currently works on analytical method development to develop fit for purpose genomic assays to characterize viral vectors across Sana gene therapy platforms.

    Abstract

    Potency is a critical quality attribute of biological products, defined by the US FDA as the specific ability of the product to cause the required therapeutically clinical benefit. Potency assay will leverage the product's mechanism of action to define the biological activity. The absence of rigorous mechanistic data for the majority of cell and gene therapy therapeutics currently in the process research pipelines has impeded efforts to design and validate indices of product potency. The current talk tries to summarize the principal and unique challenges facing the development of functionally relevant potency assays for cell and gene therapy products.

    Learning Objectives:

    1. General guidance of FDA for developing potency assays

    2. Understand unique challenges for developing in-vitro potency assays


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