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Parasitology, Immunology, Microbiology, Bioterror Agents, Grant Writing, Med Writing, Expert Witness
Expert has extensive experience in the preparation and submission of 510(k) documents to the FDA for approval of Class II medical devices. His first work in 510(k) preparation and submission was in 1987 for acceptance of a rapid immunoassay for…
Gene Expression, Genomics, Microarrays, DNA, Drug Discovery, Product Development
Expert has worked in the biotechnology industry for more than 30 years. He has directed R&D efforts in gene expression technology, genetic engineering technology, DNA microarrays, and high-throughput screening at Sandoz (Novartis), Operon, Agraquest, and GenoSpectra. He has led product…
Aseptic Process Design, Airflow Visualization, HACCP, PAI Preparation, Cleaning Validation
Expert has performed validation of aseptic processes including technologies such as blow-fill-seal, high-speed automated liquid and powder filling lines, lyophilization, barrier and isolation technology, and bulk pharmaceutical and biological processes. Expert has developed an airflow visualization procedure to assist the…
Capillary Electrophoresis Analysis, Liquid Chromatography, Therapeutic Drug Monitoring, etc.
CAPILLARY ELECTROPHORESIS; LIQUID CHROMATOGRAPHY. As one of the leading experts in high-performance capillary electrophoresis, Expert has extensive experience developing robust methods using HPCE, including those for proteins, peptides, small ions, and small molecules in a variety of matrices. His expertise…
Biochemistry and Enzymology
A primary focus of Expert E. Expert's research efforts has been the determination of the mechanism of action of enzyme-catalyzed reactions. He has applied a wide range of kinetic techniques, including steady-state and pre-steady-state studies, isotope effect studies, inhibition, inactivation,…
Mass Spectrometry, HPLC/MS, Ion Trap MS, LC/MS/MS in Environmental, Food, Proteomic, and Pharmaceutical Analysis
Expert has been hired by law firms as an expert witness in the area of analytical chemistry. He has worked with 15 law firms in his career, with some of the cases going over multiple years. This experience includes: •…
Carbohydrate Chemistry, Neoglycoconjugates, Conjugate Vaccines, Oligosaccharides, Glycoconjugates
Expert is an internationally recognized authority in carbohydrate chemistry. With over 30 years of hands-on experience in this field, he is considered among the top experts in synthetic carbohydrate chemistry in the world. Among Expert's most important achievements is his…
Biotechnology
APPLIED MICROBIOLOGY; BIOTECHNOLOGY. Expert is an authority in biotechnology, especially biotechnological principles for food, chemical, and pharmaceutical applications. He expends significant research efforts on the genetics of industrial organisms, with the ultimate goal of isolating, overproducing, and utilizing enzymes and…