Our Precision experts Karen Richards, will be attending and hosting a panel discussion at BioProduction Summit. Be sure not to miss it!
Title: Understanding the bioproduction and material requirements to support timely gene therapy AAV clinical assay and companion diagnostic development, and commercialization.
Abstract: Immunogenicity assays to measure total capsid binding antibodies (TAb) and neutralizing antibodies (NAb) are increasingly used not only to support clinical studies of AAV-based gene therapies, but also commercialization in the form of companion diagnostics or laboratory developed tests. Consequently it is important to consider early in the development process the materials that must be procured or manufactured to support these assays at various stages of the product development process. The specific materials needed for these assays, the quality evaluations, and commercialization considerations will be discussed in this Q&A session.
Precision for Medicine is part of the Precision Medicine Group, an integrated team of experts that extends Precision for Medicine’s therapeutic development capabilities beyond approval and into launch strategies, marketing communication, and payer insights. As one company, the Precision Medicine Group helps pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.
