This site is part of the Informa Connect Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

Cell & Gene Therapy Manufacturing & Commercialization Europe
5-8 December 2022
Beurs van BerlageAmsterdam, Netherlands

New for 2022: Potency Masterclass Workshop

This workshop is included in the All-Access Conference & Potency Assay Masterclass Workshop Pass

Led by Christopher Bravery, Consulting Regulatory Scientist at Advbiols on 5th December, this masterclass will focus on: 

  • Overview of what potency is, and what it is not
  • Metrological principles and their application to bioassays
  • Considerations when qualifying and validating bioassays
  • Examples of potency assays for approved products (these will consume at least half of the time);
    • Examples of a cell and gene therapy potency assays
    • From initial ideas, through characterisation to the final potency method
    • Clinical correlation
    • Regulator objections and why.

Note: this workshop is aimed at those directly involved in developing potency assays. The case studies of real potency assays will delve deeply into the underlying science for each product discussed in order to understand why the approach was taken.