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  • Feature ArticlesFeature Articles

    Designing a biologics manufacturing facility: Early planning for success

    This article reviews important steps in the manufacture of biologics. The authors provide planning steps for compliance with current good manufacturing practice (CGMP) to readiness for chemistry, manufacturing, and controls (CMC). They pose important questions manufacturers should address, from facility issues to working with a contract development manufacturing organization. They conclude that trends toward reducing the time to market put considerable stress on all aspect...