Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support. Unlike analytical test methods for small molecules, bioassays have unique requirements due to the variable nature of some critical components. Although some variability may be inherent, careful attention to setting appropriate limits and to robust qualification of critical components enhances the likelihood of success during validation.

This webinar will address several parameters that are important for the successful validation of a bioassay. Included in this discussion are multiple challenges that often lead to rework and failure that if appropriately addressed during development should not become issues that hinder validation. Appropriate training and documentation of the method are critical elements for successful transfer of a method from the development phase into the validation procedure. Accomplishing the validation of a cell-based method with little or no rework can occur with careful planning and attention to an appropriate timeline. An important factor that contributes to failure is rushing into validation without collecting the data required to support fully a decision to move toward validation. This webinar addresses those issues that may lead to failure of validations of cell-based methods while providing solid suggestions for best practices that support success.