Event Date/Time: Oct 10, 2008
mmunogenicity is the measure of the individualâ€™s immune response to a particular drug. If the drug is a biopharmaceutical there are inherent risks that can affect the potency and safety of the drug such as induction of anaphylactic reactions plus altered pharmacokinetics. Immunogenicity methods, therefore, require special attention to sensitivity and reproducibility issues, especially in the presence of interfering biological matrix components and free drug. Selection of the correct method(s) and cut-points is essential to measure and correlate the response to in vivo data. This presentation will help immunologists to efficiently develop appropriate primary and confirmatory methods and describe validation pathways that are compliant with industry expectations.
Areas Covered in the seminar:
This presentation includes the following approaches that will help avoid variability and rework throughout the life cycle of the bioassay program:
* Choosing the correct immunogenicity binding assay.
* Streamlining development.
* Setting the Correct Cut-Point.
* Managing drug interference.
* Setting validation parameters and specifications.
Who will benefit:
This Webinar will benefit any company that is presently involved in developing biopharmaceuticals such as Monoclonal Antibodies, Recombinant Proteins, large peptides and therapeutic viruses.
* Pharmacokinetic scientists and managers
* Clinical trial personnel & Biostatisticians
* QA/QC managers and personnel
* Outsourcing professionals
* Project Management
* Biotech Consultants
Ana T. Menendez, Ph.D. is Senior Director of Bioassays and Biosafety Testing at Cardinal Health. She is responsible for the release tests required to verify the functionality and purity of biotechnology products and the complex processes involved in their manufacture. Dr. Menendez implemented biotesting at Catalent Pharma Solutions and currently leads the following laboratories at the North Carolina Research Triangle Park facility: 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 obtained her Ph.D. in Microbiology/Immunology in 1995 from NY Medical College while simultaneously fulfilling her supervisory functions at Wyeth. She teaches courses on Bioassay Method Development and Validation and is a frequent international speaker at biopharmaceutical conferences.