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Managing Unexpected Events in the Manufacturing of Biologic Medicines

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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. 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.

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Acknowledgments

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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Authors and Affiliations

  1. Amgen Inc., 4000 Nelson Road, Longmont, CO, 80503, USA

    Gustavo Grampp

  2. Amgen Inc., Thousand Oaks, CA, USA

    Sundar Ramanan

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  1. Gustavo Grampp
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  2. Sundar Ramanan
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Correspondence to Gustavo Grampp.

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Grampp, G., Ramanan, S. Managing Unexpected Events in the Manufacturing of Biologic Medicines. BioDrugs 27, 305–316 (2013). https://doi.org/10.1007/s40259-013-0018-5

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