ON-DEMAND Webinar

Translation of a Diagnostic Virus Neutralization Method to a Quantitative Relative Potency Assay for an Anti-viral Antibody

Novel Approach to ADA Assay Development to Overcome Target Interference Issues from Dimerization
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Now Streaming On-Demand

Many anti-viral biotherapeutics operate through neutralization of the virus or kill infected cells and employ in vivo testing to measure potency, function and efficacy. In vivo assays are time-consuming and expensive. We developed a relative potency assay for an anti-influenza monoclonal antibody (VIS410) as a general example of the translation of a diagnostic neutralization method, the WHO microneutralization assay for influenza, into a cell-based relative potency assay.

Key Considerations

  • Understanding of the biotherapeutic and the neutralization assay
  • How the potency method was developed
  • The experimentation to establish optimal conditions
  • How this assay can be validated to current regulatory standards
About the Speakers

Our experts will discuss lessons learned from their experiences and offer insight into the multiple stages of specific assays including critical reagents, regulatory standards, assay formats and timelines.

Translation of a Diagnostic Virus Webinar

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