BioTechLogic, Inc., a biopharmaceutical manufacturing and CMC consulting firm, has announced the addition of Michael Boyne, PhD to its growing team of technical experts and consultants. Michael joins BioTechLogic from the US Food and Drug Administration where he was a Research Chemist in the Division of Pharmaceutical Analysis. As a Senior Consultant, Michael will support clients by providing expert advice on the establishment of analytical similarity for drug products using the 351 (k) pathway including protocols and requirements for statistical analysis, support the development, qualification, or validation of analytical methods used to characterize, identify, and establish the quality of intermediates, drug substances, or drug products, and draft, review, author and perform expert reviews of Pharmaceutical Quality/CMC sections (Module 3) of the CTD for regulatory submissions.
While with the agency, Michael served as an expert in bioanalytical chemistry and the development and validation/qualification of bioassays, chromatography, mass spectrometry, and spectroscopy methods used for structure elucidation of complex drug products (naturally derived and biologics), for the identification and characterization of impurities and degradation products, and for evaluating the quality of US marketplace drugs. He has authored over 30 peer-reviewed publications and is an internationally recognized speaker on the application of modern analytical technologies to the evaluation of biotechnology products. Prior to joining the FDA, Michael was a postdoctoral scholar at Washington University Medical School in Saint Louis in Oncology. Michael has a BA in Chemistry from Northwestern University, Evanston, IL and a PhD in Chemistry from the University of Illinois Urbana-Champaign.
