Bioanalysis Zone

Expert Series: The critical role of CMC in your IND submission – optimizing the CMC process

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Speaker: Glenn Petrie

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A Senior Scientific Advisor at EAG Laboratories, Dr. Glenn Petrie has more than 20 years of experience in the drug development arena with a focus on biopharmaceuticals. As a director at a major CRO he served as team leader in the development, Chemistry Manufacture and Control (CMC) design and IND submissions for a wide variety of biopharmaceuticals (monoclonal antibodies, drug conjugates, peptides, etc.). A subject matter expert in the analysis of proteins including HPLC, mass spectroscopy, ELISAs and electrophoresis, Dr. Petrie received his B.A. in Biochemistry from Rice University and his doctorate in Biochemistry from the University of Illinois Urbana-Champaign.

In this webinar, Glenn Petrie discusses best practice in optimizing the Chemistry, Manufacturing and Control (CMC) process. Drug development programs are rightfully targeted toward initiation of clinical trials. Based on this goal, emphasis is typically placed upon toxicological and pharmacological studies, sometimes at the expense of CMC. CMC is critical to IND approval and requires careful planning in order to meet all FDA requirements. This discussion will focus on the primary CMC requirements for a biopharmaceutical IND submission. The risk/reward criteria for determining the level and degree of method validation, reference standard characterization and formulation will be discussed in terms of streamlining the entire development process. In addition, possible pitfalls in the development process will be identified and addressed.

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