Development of anti-AAV assay for detection of pre-existing AAV immunity
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Development of anti-AAV assay for detection of pre-existing AAV immunity

Tuesday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST
Development of anti-AAV assay for detection of pre-existing AAV immunity

AAV vectors are used in gene therapy products for treatment of genetic diseases. The high natural prevalence of AAV wild-type viruses has resulted in a high frequency of capsid-directed humoral immunity in human populations and many animal models, which may interfere with the therapeutic efficiency of a therapy if not identified and managed properly.

This case study describes the development of an anti-AAV immune assay for use in preclinical studies using cynomolgus monkeys, with the ability to screen for pre-existing AAV immunity and to identify low-responding individuals to maximize the likelihood of successful transduction.

  • Importance of pre-screening for existing AAV immunity to maximize results of clinical/pre-clinical studies
  • Development of anti-AAV immunoassay using an automated immunoassay platform
Zhe Liu
Zhe Liu
Staff Scientist, Labcorp Early Development

Zhe Liu received her PhD in neurobiology from King’s College London in 2002. She joined Labcorp Early Development at the Huntingdon site as a Staff Scientist in April 2020. Zhe is a subject matter expert for immunoassay and performs development and validation work.

She has extensive laboratory experience in cell-based assay, immunoassay and flow cytometry in both academia and industry. In particular, she has been working in the CRO sector for 15 years with substantial experience in assay development, validation and sample analysis of ADA, PK, Biomarker and Potency.

John Chappell
John Chappell
Director of Scientific Support, EMEA and Asia Pacific, Gyros Protein Technologies

John Chappell has approximately 25 years of experience in the Contract Research industry supporting both preclinical and clinical drug development. He has specialized in supporting biological compounds from an analytical perspective e.g. Pharmacokinetic, Immunogenicity and Biomarker analysis. He is particularly interested in validation requirements and ensuring that data generated will be acceptable to the regulatory authorities.

He has spoken at many international conferences on various topics including Oligonucleotide analysis, Biomarker Analysis, Immunogenicity and the analytical support of Biosimilar programs.

He now leads the Application Support and Service teams for Gyros Protein Technologies.