Risk-Based Assay Development Strategies for Cell Therapies

24 June 2021

Getting a cell or cell-based therapy from early stages of development through commercialisation requires more than one would assume. One of the many critical milestones is to be able to characterise the therapy and demonstrate its safety and its potency.

In the absence of international standards, therapeutic developers have to consider a variety of regional requirements and develop their testing strategy accordingly. What to test for? What is needed? At what stage? Is there a need to develop a series of custom assays? How to go about it? When? Quantitative vs. qualitative? Can qualitative blood screening assays be used for safety?

Catch up with this webinar, hosted in partnership with QualTex Laboratories – a subsidiary of BioBridge Global – to hear the answers directly from the experts!


Part 1:

The panel will discuss the importance of defining your testing strategy early in your therapeutic development program, in partnership with the right laboratory partner.
•Define Critical Quality Attributes for your therapy to facilitate analytical target profile
•Plan ahead for diversity of regional requirements
•Establish when to use readily available assays
•Find the right partner for custom assay development

Part 2:
This is an opportunity for you to ask questions to the experts on how to integrate your testing strategy into your therapeutic development, or listen to an audience Q&A on demand.

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