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Category: Immunogenicity

<a href="https://www.bioagilytix.com/blog/category/cro-selection/">CRO Selection</a>

To the Rescue: Applying a Novel Approach to Minimize False Positive ADA Assay Results

  • July 2, 2019

Target interference can cause false positive ADA assay results and stall out promising drugs. This could have been the case for one study involving an…

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<a href="https://www.bioagilytix.com/blog/category/gene-therapy/">Gene Therapy</a>

Your Questions About Immunogenicity Assessment of Gene Therapy Compounds Answered

  • June 14, 2019

The webinar I recently hosted with my colleague Lydia Michaut explored key challenges and trends in the immunogenicity assessment of gene therapy compounds. This recap…

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<a href="https://www.bioagilytix.com/blog/category/industry-update/">Industry Update</a>

New FDA Guidance on Developing and Validating Assays for ADA Detection: Key Updates and Clarifications

  • March 15, 2019

The FDA’s recently released new guidance, designed to facilitate development and validation of assays for the detection of anti-drug antibodies for immunogenicity testing, includes several…

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