Implementing Process Controls for Cell-Based Assays

Bioassays are used to demonstrate that a biological product performs per the stated function and potency.

Typically, these methods are performed in living systems. Cell-based methods can have inherent variability due to the nature of living systems. Minimizing potential variability can be achieved through careful documentation and analysis of assay performance on control charts. Monitoring numerous parameters may assist laboratory scientists, laboratory managers, QC, and QA personnel to identify and manage trends that could lead to OOS/OOT results. Monitoring also decreases failure rates by trending parameters that have a direct impact on cell-based methods meeting acceptance criteria. A significant consideration for these methods is setting appropriate system suitability that is consistent with methods that experience higher variability. Since the number of parameters evaluated is dependent on the cell type, assay type, and a number of critical components or reagents, this webinar will provide a general overview of the topic as well as specific…