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Originally Hosted:
Thursday, October 10, 2019
11:00am – 12:00pm EDT

Challenges in Adapting Neutralizing and Anti-Drug Antibody Assays to Gene Therapies

This presentation summarizes a recently published whitepaper by Absorption Systems.

We will discuss the process of developing and validating tests for detecting ADAs and NAbs. Given that the host immune response may be triggered by the AAV vector capsid, the therapeutic gene/ RNA, and the translated protein, a multi-tiered approach is required.  There are numerous challenges in developing ADA tests. These include:

  • Selection of the optimal methodology
  • Choice of cell line for NAb assays
  • Determining the appropriate cut-off point
  • Utilizing appropriate positive controls

Here we share our experience in overcoming these challenges and set out best-practice criteria.

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