Managing Unexpected Events in the Manufacturing of Biologic Medicines
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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. As required by regulators, such an organization must monitor the state-of-control for the manufacturing process. A high-reliability organization also invests in an experienced and fully engaged technical support staff and fosters a management culture that rewards in-depth analysis of unexpected results, robust risk assessments, and timely and effective implementation of mitigation measures. Such a combination of infrastructure, technology, human capital, management, and a science-based operations culture does not occur without a strong organizational and financial commitment. These attributes of a high-reliability biologics manufacturer are difficult to achieve and may be differentiating factors as the supply of biologics diversifies in future years.
KeywordsRecombinant Human Erythropoietin Consent Decree Industry Peer Warning Letter Quality Target Product Profile
Gustavo Grampp and Sundar Ramanan are employees of Amgen Inc. and own stock in Amgen Inc. Gustavo Grampp devised the concept for this paper; Gustavo Grampp and Sundar Ramanan wrote the paper; Amgen Inc. approved the manuscript for submission. Kathryn Boorer PhD of Amgen Inc. provided editorial assistance.
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