SOMERSET, N.J. – September 25, 2017 — Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today announced that two of its leading biologics analytical experts will be presenting workshops on the development and validation of bioassays at two upcoming conferences.
At the BEBPA 10th Annual Bioassay Conference, to be held at The Radisson Blu Hotel, St. Julian's, Malta, on Sept. 27-29, 2017, Mike Merges, Director of Strategic Growth of Biologics Analytical Services and Mike Sadick, Ph.D., Principal Scientist, Biologics Analytical Services, Development, will host a daylong workshop, on Wednesday Sept. 27, titled “Make Your Bioassay Great…The First Time” covering a wide range of issues concerning the development and optimization of bioassays. The workshop will include an overview of the basic tools required for success: analyst training, critical reagent maintenance, laboratory/equipment set up, assay formats, cell maintenance, propagation and banking, as well as regulatory expectations for phase I/II/III clinical trials. Practical approaches to understanding the fundamental aspects of bioassays, including design of assay formats, system suitability and preparation for bioassay transfer, will also be discussed, alongside working effectively with a contract development and manufacturing organization.
The second event, KNect365 Life Sciences' 21st annual Well Characterized Biologics & Biological Assays Conference, will take place at the Hilton Washington DC / Rockville Hotel & Executive Meeting Center, Rockville, Maryland on Oct. 25-27. Again, Mike Merges and Mike Sadick will host a full day’s workshop session, titled “Building a Better Bioassay: An Introduction to Bioassay Development” on Wednesday, Oct. 25. The topics covered will be similar to those discussed at the previous event, and will draw on case studies to highlight examples and share experiences in this area.
Dr. Sadick has an extensive background in cellular biology, cellular immunology, receptor signaling, molecular biology and biochemistry. He has more than 30 years’ experience in research and industry, having held positions at Genentech, Eli Lilly and Aptuit before joining Catalent in 2012. His current role sees him lead Catalent’s activities in potency assays, both cell-based and enzyme-linked immunosorbent assay (ELISA) based, as well as molecular biology (including cloning and quantitative polymerase chain reaction (qPCR)), and protein/protein binding assessment. He holds a bachelor’s degree in biology from John Hopkins University, and a master’s degree and doctorate, both in immunology, from the University of Washington.
Mr. Merges joined Catalent in 2011 as Director of Catalent Biologics Analytical Services, focusing on the transfer, development, validation, and performance of bioassays, immunoassays, microbiological assays, and viral clearance assays. Before that, he was Associate Director of Bioservices for Lonza Biologics, and has also held positions at the University of Maryland’s Institute of Human Virology, the National Cancer Institute and Johns Hopkins University, where he conducted viral immunology research. He obtained his bachelor’s degree in microbiology from the Pennsylvania State University, and his master’s degree in microbiology/virology from Hood College.
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Catalent is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 10,000 people, including over 1,400 scientists, at more than 30 facilities across five continents, and in fiscal 2017 generated more than $2 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com