Managing unexpected events in the manufacturing of biologic medicines

BioDrugs. 2013 Aug;27(4):305-16. doi: 10.1007/s40259-013-0018-5.


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.

Publication types

  • Review

MeSH terms

  • Accident Prevention*
  • Biological Factors / adverse effects
  • Biological Factors / analysis
  • Biological Factors / biosynthesis*
  • Biological Factors / chemistry
  • Biological Products / adverse effects
  • Biological Products / analysis
  • Biological Products / chemistry
  • Biological Products / metabolism*
  • Biotechnology / trends
  • Chemistry, Pharmaceutical
  • Drug Contamination / prevention & control
  • Drug Industry / trends
  • Drug Packaging
  • Drug Stability
  • Guideline Adherence
  • Guidelines as Topic
  • Humans
  • Quality Control
  • Reproducibility of Results
  • Risk Assessment
  • Risk Management*
  • United States
  • United States Food and Drug Administration
  • Workforce


  • Biological Factors
  • Biological Products