Custom Assay Development for Cell Therapies

Phacilitate
27 September 2021
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In this short presentation, Scott Jones from BioBridge Global describes five risk mitigation strategies for assay development for cell and cell-based therapies.

Hello, I’m Scott Jones, I’m Vice President of Scientific Affairs for BioBridge Global. I’m here to outline some key highlights from my latest presentation on custom assay development for cell and cell-based therapies.

Three takeaways from my presentation are:

One – some level of custom assay development will be required, especially regarding potency testing, and start this custom development as soon as you can.

Two – use qualitative high throughput safety assays when possible.

And then the last one – perform Phase-appropriate validations for your assays.

In recent years the cell and cell-based therapy industry has experienced increasing capacity constraints in routine product testing and analytical assay development. These constraints have caused major issues, specifically, delays in product development, product supply, clinical trials, regulatory filings, and even approvals of the products.

My presentation will cover five testing strategies that can help mitigate these risks.


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