Recommendations for Cell Banks used in GXP testing

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.

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.

Learning Objectives:

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.

Who Will Benefit:

This webinar will provide valuable assistance to following personnel in biotech and pharmaceutical companies:

• Bioassay specialists
• Pharmacokinetic/Pharmacodynamic analysts
• Neutralization biologists
• QA/QC
• Project Managers
• Regulatory personnel
• Consultants

Instructor Profile:

Dr. Menendez, is currently an international instructor and consultant on GMP/GLP Bioassay and Bioanalytical Method Development and Validation. In her previous position as Senior Director of Biotechnology at Catalent Pharma Solutions she implemented various laboratories to verify the functionality and safety of biotechnology products using cellular, molecular and immunological technologies. Her expertise covers potency bioassays, PK and immunogenicity testing. Her latest industry paper provides recommendations for preparing and storing non-manufacturing cell banks used in GMP and GLP analysis.

Dr Menendez joined Catalent from Bristol-Myers Squibb, where as Associate Director of Regulatory Sciences, she transitioned Oncology and Infectious Diseases candidates from the lab bench to the clinic. Dr. Menendez obtained her Ph.D. in Microbiology/Immunology and she pioneered monoclonal antibody technology at Wyeth from 1982 to 1995.

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