GMP (Good Manufacturing Practices) are defined by the World Health Organization as “The aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.” The Organization has been refining its GMP guidance since 1968 for general pharmaceuticals, adding biologics-specific guidance in 1991. As such, guidelines for quality assurance are certainly well-refined and clearly defined.
But, while GMP adherence might seem like a prescriptive series of boxes that biopharmaceutical producers are responsible for checking off, there’s a bit more strategy involved as it relates to a company’s overarching CMC (chemistry, manufacturing, and controls) strategy.
Dr. Shabbir Anik, Chief Technical Operations Officer at Sutro Bio, joined The Business Of Biotech podcast for a discussion on his company’s holistic view of CMC, and how it dovetails into its GMP quality assurance initiative and budgetary planning efforts. For context, Sutro Bio has developed a proprietary platform for the development of antibody-drug conjugates (ADCs) bispecific antibodies, and cytokine derivatives to treat a number of oncology indications. Here are just a few of the suggestions Dr. Anik shared on the episode.