2012 - Recommendations for Cell Banks used in GXP testing

This webinar presents a best practices approach for preparing, characterizing and storing cell banks used for GXP analytical and bioanalytical test methods. It covers critical topics such as timelines for generation of cell banks, equipment, growth conditions, purity, consistency, and stability.
Why Should You Attend:
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.
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.