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Research ArticleCommentary

Essential Aspects in Assessing the Safety Impact of Interactions between a Drug Product and Its Associated Manufacturing System

Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology January 2012, 66 (1) 63-77; DOI: https://doi.org/10.5731/pdajpst.2012.00742
Dennis Jenke
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Abstract

An emerging trend in the biotechnology industry is the utilization of plastic components in manufacturing systems for the production of an active pharmaceutical ingredient (API) or a finished drug product (FDP). If the API, the FDP, or any solution used to generate them (for example, process streams such as media, buffers, and the like) come in contact with a plastic at any time during the manufacturing process, there is the potential that substances leached from the plastic may accumulate in the API or FDP, affecting safety and/or efficacy. In this article the author develops a terminology that addresses process streams associated with the manufacturing process. Additionally, the article outlines the safety assessment process for manufacturing systems, specifically addressing the topics of risk management and the role of compendial testing. Finally, the proper use of vendor-supplied extractables information is considered.

LAY ABSTRACT: Manufacturing suites used to produce biopharmaceuticals can include components that are made out of plastics. Thus it is possible that substances could leach out of the plastics and into manufacturing solutions, and it is further possible that such leachables could accumulate in the pharmaceutical product. In this article, the author develops a terminology that addresses process streams associated with the manufacturing process. Additionally, the author proposes a process by which the impact on product safety of such leached substances can be assessed.

  • Manufacturing systems
  • Extractables
  • Leachables
  • Safety assessment
  • Drug product interactions

Footnotes

  • Conflict of Interest Declaration The author declares that he has no competing interests.

  • © PDA, Inc. 2012
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PDA Journal of Pharmaceutical Science and Technology: 66 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 66, Issue 1
January/February 2012
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Essential Aspects in Assessing the Safety Impact of Interactions between a Drug Product and Its Associated Manufacturing System
Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology Jan 2012, 66 (1) 63-77; DOI: 10.5731/pdajpst.2012.00742

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Essential Aspects in Assessing the Safety Impact of Interactions between a Drug Product and Its Associated Manufacturing System
Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology Jan 2012, 66 (1) 63-77; DOI: 10.5731/pdajpst.2012.00742
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  • Article
    • Abstract
    • Introduction
    • Terminology
    • Risk Management and Safety Assessment
    • Testing Intervals in a Migration (Leachables) Study
    • Proper Use of Suppliers' Extractables Data
    • Conclusion
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Cited By...

  • Development and Justification of a Risk Evaluation Matrix To Guide Chemical Testing Necessary To Select and Qualify Plastic Components Used in Production Systems for Pharmaceutical Products
  • Google Scholar

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  • Parametric Release of Moist Heat Sterilized Products: History and Current State
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