Validation of Immunogenicity Assays for Biologicals

The past decade has seen a rise in the number and indications of biopharmaceutical drugs. Their unique properties and targeting potential can be exploited in many therapeutic areas. Unexpected immunogenicity from these biologicals (i.e., proteins, stem cells, therapeutic viruses, etc.) can easily derail the most potent drug by decreasing the efficacy or initiating a dangerous hypersensitivity response.
Early detection of immunogenicity reactions is a key component of a drug development program. Immunogenicity assays can be challenged by lack of human positive controls and ambiguity in choosing a meaningful cut-point.

Areas Covered in the Seminar:

• Expectations of the GLP (GCLP) environment
• Choosing the correct technology
• Effective assay development
• Minimizing matrix effects
• Selecting the cut point
• Titration curves
• Setting specifications for the validation protocol

Who Will Benefit:

• Bioanalytical scientists
• Pharmacokinetic specialists
• Biotech R&D staff
• Clinical research associates
• Validation specialists
• Project Management
• Regulatory staff
• QA/QC
• Outsourcing Professionals
• Biopharmaceutical Consultants

Instructor Profile:

Ana T. Menendez , is Senior Director of Biotechnology at Catalent, a full-service solution provider to the pharmaceutical industry. Dr. Menendez implemented biotesting at Catalent with the following services: Cellular Technologies, Molecular Technologies and Virology. The expertise of the department ranges from proteins (i.e., monoclonal antibodies, enzymes, growth factors) to therapeutic viruses, bacterial vaccines and aptamers.

Dr. Menendez joined Catalent from Bristol-Myers Squibb (BMS) where she held a number of positions of increasing responsibility from 1995 to 2001. As the head of the Cancer Cell Biology department Dr. Menendez identified and/or optimized several compounds currently in clinical trials, including second-generation taxanes and inhibitors of the ras and src oncogenes. Her seminal apoptosis research (programmed cell death) was critical to the incorporation of a drug’s pro-apoptotic potential into the BMS decision pathway for oncology drug generation. While Associate Director of Regulatory Sciences she assisted the transition of Oncology and Infectious Diseases leads from the lab bench to the clinic. From 1982 to 1995, Dr. Menendez pioneered monoclonal antibody technology at American Cyanamid/Wyeth and was responsible for all the immunoassays and in vitro bioassays for Mylotarg, an anticancer monoclonal antibody – toxin conjugate that was approved in 2000.

Dr. Menendez obtained her Ph.D. in Microbiology/Immunology in 1995 from NY Medical College while simultaneously fulfilling her supervisory functions at Wyeth. She teaches courses and leads workshops on Bioassay Method Development and Validation and is a frequent speaker at biopharmaceutical conferences.

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