Cell-based assays are routinely used during biopharmaceutical development for the assessment of product potency, the determination of pharmacokinetic and pharmacodynamic profiles and the detection of neutralizing antibodies, among other applications. The accuracy and reliability of test results generated by these methods is critically dependent upon the production of controlled and consistent cell banks.
This webinar provides logical guidance for scientists that need to create critical cell banks for their GMP, GLP or GCLP testing projects. Current regulatory guidelines apply only to cell banks used to manufacture biopharmaceutical products to ensure their safety for human use. No guidance has been provided for cells that will be used as critical reagents in methods that require significant accuracy and precision. The strategies described in this webinar close the knowledge gap by describing best practice approach to establish, characterize and maintain controlled and consistent sources of cells using a risk-based and product phase-appropriate approach.
Learn how to generate and store cell banks that are compliant with GXP expectations.
Areas Covered in the Seminar:
- Regulatory background.
- Feasibility and timeline.
- Preparation of cell banks to ensure consistency.
- Storage of cell banks to certify stability.
- Risk-based characterization strategy.
- Appropriate documentation plans for protocols and certificate of analysis.