Applying a matrix approach for potency assay development for in vivo and ex vivo gene therapies

Broadcast date

Mon, Mar 14, 2022

 

Presented by

    Dominic Hildebrand - Bayer
    Shihua Lin - AstraZeneca

 

Quick Description

The webinar aims to bring an awareness of the challenges associated with developing potency assays that adequately reflect the mechanism of action (MoA) of gene therapies (GTs). ​

Details

The webinar aims to bring an awareness of the challenges associated with developing potency assays that adequately reflect the mechanism of action (MoA) of gene therapies (GTs). ​

Understanding MoA for GTs is complex where more than one function is critical to the therapeutic activity; targeting a single attribute for the potency assay is not sufficient. A matrix approach is proposed with examples provided to demonstrate this potency assay development strategy in practice for in vivo and ex vivo GTs. 

Proposed solutions to overcome challenges often associated with reference standards and assay controls for potency assays are also offered.


Q&A panelists

  • Roland Pach – Associate Director, Roche
  • Christina Grigoriadou – Associate Director, AstraZeneca
  • Win Den Cheung – Director, Analytical Development, REGENXBIO

Speakers

Dominic Hildebrand

Head of Laboratory, Analytical Development and Quality Control

Bayer

Shihua Lin

Director

AstraZeneca