Designing Robust Cell-Based Assays MasterClass - EU edition

These assays should then be appropriately validated before performing the process performance qualification. This Master Class addresses common bioassay formats, as well as the development and validation of bioassays.

04-05 February, 2026, Virtual

Time Zone: UTC/GMT+1 /CET

Overview

For the release of biotechnological products, potency is a mandatory critical quality attribute that manufacturers must evaluate to ensure it conforms to specifications for releasing drug substance and drug product batches. Cell-based bioassays are commonly used to determine potency. While binding assays, including non-cell-based assays, can be considered during early clinical development, regulatory bodies expect that cell-based bioassays reflecting the mechanism of action of the biotherapeutic be developed and implemented during late clinical development.

These assays should then be appropriately validated before performing the process performance qualification. This Master Class addresses common bioassay formats, as well as the development and validation of bioassays.

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WHO SHOULD ATTEND

-Statisticians
-Assay development Scientists
-Bioassay Planner
-Monitoring Personnel
-Assay Managers
-Bench Scientist
-Validation Analyst