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.
- 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
Who may this interest?
- Biotechnology professionals
- Pharmaceutical professionals
- Medical professionals
Jeffrey Patrick, PhD
Director – GMP
BioAgilytix (NC, USA)
Jeff serves in the role of Director of the GMP Potency team at BioAgilytix. He has more than 25 years of experience in biopharmaceutical development, manufacturing and testing, including upstream and downstream development and analytical support, GMP QC lab consulting and biologics discovery and early phase development. He has broad expertise in method development, validation, transfer and implementation in CMC manufacturing settings with a focus on implementation as part of a CMC strategy and control of SISPPQ or critical product attributes.
Jessica has more than 14 years of experience working in both academia and CMO/CROs in the North Carolina area and brings with her extensive GMP regulatory knowledge. In her role at BioAgilytix, Jessica works to manage a team of project managers, scientists and analysts specializing in GMP cell-based potency assays. She is also experienced in method feasibility, development, optimization, transfer, qualification, validation and GMP stability and lot release testing.
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