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Article originally published on GEN The biotechnology industry achieved many firsts this past year, from the first approved drug that can slow the rates of cognitive and functional decline in adults with Alzheimer’s disease, to the first CRISPR-based gene editing...

Ashley Ruth, PhD joins BioTechLogic from FDA

BioTechLogic, Inc., a biopharmaceutical manufacturing and CMC consulting firm, has announced the addition of Ashley Ruth, PhD to its growing team of technical experts and consultants. Ashley joins BioTechLogic from the US Food and Drug Administration, Center for Drug Evaluation and Research, where she was a Research Chemist within the Division of Pharmaceutical Analysis. As a Senior Consultant in Analytical Services, Ashley will support clients in a variety of areas. She will provide expert advice for the development, qualification and/or validation of analytical methods pertaining to biopharmaceutical analysis and CMC development used throughout the drug development and approval process under GxP guidelines. She will also provide expert advice on the establishment of analytical biosimilarity for drug product using the 351(k) pathway, the generation of comparability plans and protocols, analytical method transfer, and SOP generation and compliance. She will also draft, review, author and perform expert reviews of the Pharmaceutical Quality/CMC sections (Module 3) of the CTD for regulatory submissions. Ashley is also an expert in data compliance and integrity, with experience implementing such workflows for the FDA laboratory while at the agency.

 

While with the Agency, Ashley served as an expert in bioanalytical method development, qualification and validation, with expertise in mass spectrometry, chromatography and spectroscopy. Her work focused on the use of advanced analytical technologies for the characterization of complex biological drug products, with emphases on complex peptide products and higher order structure characterization. Her work also included studies correlating physicochemical characterization with functional assays. She has authored 17 peer-reviewed publications and is involved with several professional societies, including the American Society for Mass Spectrometry and CASSS. Prior to joining FDA, Ashley was a Chateaubriand Fellow of the Office of Science of Technology of the Embassy of France in the United States at École Polytechnique in Palaiseau, France. Ashley has a BA in Chemistry from Pomona College in Claremont, California and a PhD in Chemistry from the University of Arizona.

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