title: 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. 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.
authors.affiliation: Amgen Inc., 4000 Nelson Road, Longmont, CO 80503, USA. ginog@amgen.com
authors.forename: Gustavo
authors.initials: G
authors.lastname: Grampp
authors.forename: Sundar
authors.initials: S
authors.lastname: Ramanan
mesh_terms: D000056:Accident Prevention; D001685:Biological Factors / Q000009:adverse effects / Q000032:analysis / Q000096:biosynthesis* / Q000737:chemistry; D001688:Biological Products / Q000009:adverse effects / Q000032:analysis / Q000737:chemistry / Q000378:metabolism*; D001709:Biotechnology / Q000639:trends; D002626:Chemistry, Pharmaceutical; D004340:Drug Contamination / Q000517:prevention & control; D004345:Drug Industry / Q000639:trends; D004349:Drug Packaging; D004355:Drug Stability; D019983:Guideline Adherence; D017408:Guidelines as Topic; D006801:Humans; D011786:Quality Control; D015203:Reproducibility of Results; D018570:Risk Assessment; D012308:Risk Management; D014481:United States; D014486:United States Food and Drug Administration; D000078329:Workforce
chemical_list: D001685:Biological Factors; D001688:Biological Products