Consultant

California, USA

With 20 years of experience in the pharma/biotech industry, Anton Stetsenko is a consultant in CMC potency method development, validation, and troubleshooting. He specializes in in vitro enzyme activity, cell-based assays, immunoassays, and animal models. Anton has worked at Abbott Laboratories, Fresenius Kabi (formerly APP Pharmaceuticals), Dynavax Technologies, Orchard Therapeutics, ADC Therapeutics, 4D Molecular Therapeutics, and Orca Bio, where he was responsible for all aspects of the potency method lifecycle including comparability studies, method transfer, personnel training, data tracking and trending, customization of data analysis, preparation of regulatory submissions, reference standards, and qualification of critical reagents. This journey allowed him to learn about CMC potency aspects specific to different biopharmaceutical products such as small molecules, biosimilars, vaccines, antibody-drug conjugates, gene and cell therapies. He holds a Doctor of Medicine degree with an emphasis on clinical biochemistry from the Russian National Research Medical University and an MBA in General Business from Lake Forest Graduate School of Management.