Managing Unexpected Events in the Manufacturing of Biologic Medicines

Abstract

The manufacturing of biologic medicines (biologics) requires robust process and facility design, rigorous regulatory compliance, and a well-trained workforce. Because of the complex attributes of biologics and their sensitivity to production and handling conditions, manufacturing of these medicines also requires a high-reliability manufacturing organization… (More)
DOI: 10.1007/s40259-013-0018-5

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