Cell-based bioassays are a cornerstone of potency testing, safety assessment, and regulatory approval, as they provide data that more accurately reflects cellular behavior than assays targeting isolated components. However, their development is highly challenging due to biological variability, complex mechanisms of action, and evolving regulatory expectations, making CBBAs a high-stakes element of drug development. This panel will cover:
- Method selection for different modalities, with a focus on potency
- Key considerations and common pitfalls in assay development
- Examples of potency assays for mAbs, ADCs, and other biologics
Tuesday, May 5, 15:00 - 15:45, room Shanghai 1+2
| Name | Position | Institution |
|---|---|---|
| Charlie Brault | Digital Marketing Manager | Solvias |
| Name | Position | Institution |
|---|---|---|
| Daniel Galbraith | Chief Scientific Officer | Solvias |
| Thomas Millward | Director, Bioanalytics | Novartis |
| Reginald Clayton | Dir. Field Development, Head of Biosafety & Deputy Site Head | Solvias |
| Devadarssen Murdamoothoo | Director of Operations, Cell-based Bioassay | Solvias |
Solvias helps innovative companies advance their path to commercialization with CMC analytical solutions powered by deep scientific expertise and a relentless focus on customer success. With extensive experience in small molecules, biologics, and cell and gene therapies, our experts apply creativity and rigor to solve even the most complex analytical challenges. Customers gain a single, trusted partner through our GMP, GLP, and ISO-certified facilities across five global locations, conducting over 100 successful audits each year.
