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eChalk Talk: Bioanalytical Considerations for Adeno-Associated Virus (AAV) Gene Therapy Drugs


Viral vector-based gene therapies continue to grow with several products now approved and a flowing pipeline of candidates seeking approval in the coming years. To date, the most commonly used vectors are adeno-associated virus (AAV) based. The FDA does not currently provide guidance on how to approach immunogenicity assay development and validation when using emerging or existing technologies - a requirement to determine exposure in the preclinical and clinical phases of drug development. As a result, there is an increased need for scientific expertise to develop bioanalytical strategies utilizing new technologies as well as existing platforms within the regulated bioanalysis space to assess the safety of new AAV products. In this eChalk Talk, we will discuss considerations for AAV-based gene therapy programs, and best approaches and strategies for development and validation of assays to support regulated bioanalysis.


  • Brad Reinholt, Ph.D.

    Brad Reinholt obtained his Ph.D. in Animal Sciences at Virginia Tech in 2015. He went on to complete a postdoctoral fellowship at the Icahn School of Medicine at Mount Sinai in New York, NY in the department of Hematology and Medical Oncology. He joined Charles River in 2018 and is currently a Scientist in the Immunology Department at the Mattawan, MI site. Brad has over nine years of experience developing and validating ligand binding assays. Since joining Charles River, he has become the department subject matter expert for ligand binding assays supporting gene and cell therapy programs. He has developed and validated many nonclinical and clinical bioanalytical methods around the immunogenicity of Adeno-Associated Virus (AAV) based gene therapy programs utilizing both cell and non-cell-based platforms. He contributed to global initiatives to standardize and streamline the approaches used to develop AAV-based gene therapy programs and bioanalytical methods to assess AAV immunogenicity.

March 2, 2022
Wed 11:15 AM EST

Duration 0H 30M

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