Accelerating Bioassay Transfer in a GMP Environment

Why Should You Attend:

50% of the drugs presently in discovery are biopharmaceuticals - these numbers lead to an "outsource or perish" philosophy for GMP/GLP development, validation and sample analysis. Unlike synthetic drugs requiring only straightforward analytical testing biopharmaceuticals require more elaborate assays to attain regulatory compliance. The industry has a significant underestimation of the discipline; skills and planning required to successfully transferring these assays. Naiveté in this area causes loss of precious time and money during development.

Participants in this seminar will attain a valuable checklist of critical information that will reduce delay and confusion during method transfer. The hands-on, common sense approach will provide a chronological pathway that can easily be adapted for any complex assay.

Areas Covered in the seminar:

This webinar systematically outlines the steps needed to successfully transfer validated biological assays between GMP/GLP labs and also acquire non-validated assays for GMP/GLP development. Topics to be addressed are:

• Setting a realistic timeline for your assay transfer.
• Issues that need to be addressed in preliminary discussions between the labs.
• Proper method writing.
• Parameters to be evaluated during transfer - the transfer protocol.
• Transfer report.

Who Will Benefit:

Participants in this seminar will attain a valuable checklist of critical information that will reduce delay and confusion during method transfer. The hands-on, common sense approach will provide a chronological pathway that can easily be adapted for any complex assay

• Bioasssay and Analytical Scientists
• Pharmacokinetic/Pharmacodynamic Scientists
• Outsourcing Professionals
• Project Management
• Regulatory Staff
• QA/QC
• Consultants

Instructor Profile:

Dr. Menendez, is currently an independent consultant and international instructor on GMP/GLP Bioassay Method Development. 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 procedures. 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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