Somerset, N.J. – March 20, 2015 — Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today announced that Dr. Mike Sadick, Senior Manager, Large Molecule Analytical Chemistry, and Dr. Tom Luntz, Group Leader, Cell Based Assays, will both speak at the upcoming CASSS Bioassay 2015 Conference, to be held at the Sheraton Spring Hotel, Silver Spring, MO, on March 23rd – 24th, 2015.
Dr. Sadick’s presentation, on March 23rd at 2.25 p.m., is entitled “Development and Qualification of a Robust and Easily Executable Bioassay using mRNA transcription, assessed with Dual RT-qPCR, as Assay Response,” and will demonstrate the development of a potency bioassay using transcriptional gene regulation. By using a real time quantitative reverse transcription assay, alongside a Taqman® assay chemistry in a duplex format on a cell line, Catalent has been able to develop an assay to assess induction or inhibition of ligand-induced bioactivity with excellent precision, assay range and reproducibility.
Dr. Luntz will present on March 24th, at 9.50 a.m., on the subject of “Bioassay Evolution and Lessons Learned,” and will discuss the development, evolution and validation of bioassays throughout the pathway of drug commercialization. Using practical examples, he will demonstrate how a bioassay has to be appropriate for growing demands, from initially reflecting the mechanism of action of a drug product to becoming suitable to use for future lot release and stability testing.
Dr. Sadick has over twenty five years of experience within the industry, having worked in the research faculty at UCSF Medical Centre, before joining Genentech as a Senior Scientist in the Bioassay Group supporting Pharmaceutical Science efforts (Phases I - III), and latterly as a Research Advisor at Eli Lilly and Company. He joined Aptuit in 2007 and became Senior Manager of Biopharmaceutical Characterization Services when Catalent acquired Aptuit Clinical Trials Supply in 2012.
Dr. Sadick manages the team 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 Bachelor’s Degree in Biology from Johns Hopkins University and his Master’s Degree and Ph.D. in Immunology from the University of Washington.
Dr. Luntz has 30 years of technical experience and 10 years within the industry, having worked in the Agricultural Biotechnology Research Unit (ABRU) of Ciba-GEIGY, and in the UNC School of Medicine before joining Catalent in 2005. As Group Leader of the Cell-Based Assay Group, he manages the team responsible for method development, transfer, qualification, and validation of cell-based test procedures, and also quality control testing following those methods. Dr. Luntz received his Bachelor’s Degree in Biology from Lehigh University and his Ph.D in Biochemistry from Texas A&M University.
For more information on the CASSS Bioassays Conference, visit: http://www.casss.org/?BIOA1500 and to arrange a meeting with either of the Catalent executives, contact Ed Dutton at NEPR: Edward@nepr.eu.
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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 8,500 people, including over 1,000 scientists, at nearly 30 facilities across 5 continents and in fiscal 2014 generated more than $1.8 billion in annual revenue. Catalent is headquartered in Somerset, N.J. For more information, visit www.catalent.com