Catalent case study presented on achieving Biological Assay

Mr. Merges and Dr. Sadick will center the workshop on the concept that biological assays can be precise and easy to perform by providing an overview of the basic tools required for biological assay success. The technical team will present case studies to support and discuss practical approaches to designing assay formats, system suitability, and preparation for bioassay transfer. Specific areas of focus include:

• Analyst Training
• Critical Reagent Maintenance/Care
• Assay Formats, including use of novel assay systems
• Cells
• Setting and Use of Proper Assay Acceptance Criteria
• Laboratory/Equipment Set-Up
• Regulatory Expectations for Phase l,ll & lll Clinical Trials
• Team with a CRO?

Michael Merges is Director of Catalent’s Biopharmaceutical Support Services focusing on the transfer, development, validation, and performance of bioassays. Mr. Merges has experience with many techniques including cell-based (primary cells and cell lines) bioassays, immunological/neutralization assays, ELISA, and Flow Cytometry. He joined Catalent from Lonza where he was Associate Director of Bioservices. Prior to that, he was at the University of Maryland’s Institute of Human Virology where he served as the Institute’s Research Supervisor. He has also conducted viral immunology research at the National Cancer Institute and Johns Hopkins University. He obtained his Bachelors Degree in Microbiology from The Pennsylvania State University and his Masters Degree in Microbiology/Virology from Hood College.

In 2012, Dr. Sadick joined Catalent as Senior Manager of Biopharmaceutical Characterization Services. His team is responsible for transfer, development, validation, and performance of bioassays and the development, validation, and performance of molecular biological approaches, including qPCR and cell engineering. In addition, his group is responsible for transfer, development, validation, and performance of electro-separation techniques, including slab-gel electrophoresis and capillary electrophoresis. Dr. Sadick received his Bachelors Degree. in Biology from Johns Hopkins University and his Masters Degree and Ph.D. in Immunology from the University of Washington. He worked as research faculty at UCSF Medical Center for five years. Following his work at UCSF Medical Center, Dr, Sadick then worked for 10 years at Genentech in South San Francisco as a Senior Scientist in the Bioassay Group supporting Pharmaceutical Science efforts (Phases I – III). Dr. Sadick then worked for Eli Lilly and Co. as a Research Advisor to help lead biotechnology efforts, including the Bioassay Groups, Molecular Biology and Virology in support of Phase I-III projects, as well as providing guidance for commercial bioassay testing, all on a global level, working with FDA and EMEA regulatory agencies, as well as serving on several conference scientific steering and review committees.

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