Points to Consider for the CMC Development of Therapeutic Biologics
Posted on March 1, 2017
Willie Wilson III, Ph.D., Primary Product Quality Reviewer
Office of Biotechnology Products
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Recombinant therapeutic proteins are biologic drugs produced by living host cells using recombinant DNA technology. Since the first United States approval of a recombinant therapeutic protein (human insulin) in 1982, biopharmaceutical development has evolved into a multi-billion dollar industry lead...
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Related Topics and Keywords
CMC, mAb, monoclonal antibodies, Recombinant therapeutic proteins, Willie Wilson
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