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  1. Home
  3. Simulating Extractables And Leachables In Biopharmaceutical Manufacturing To Support Safety Assessment.
  1. Home
  3. Simulating Extractables And Leachables In Biopharmaceutical Manufacturing To Support Safety Assessment.

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Simulating extractables and leachables in biopharmaceutical manufacturing to support safety assessment.

Maximilian Bossong1, Armin Hauk2, Ina Pahl2

  • 1Department of Biopharmaceutics and Pharmaceutical Technology, Institute of Pharmaceutical and Biomedical Sciences, Johannes Gutenberg University, Mainz, Germany; Sartorius Stedim Cellca GmbH, Marie-Goeppert-Mayer-Straße, 89081 Ulm, Germany.

European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences
|September 10, 2025

View abstract on PubMed

Summary
This summary is machine-generated.

This study introduces a modeling approach to assess risks from leachables in biopharmaceutical manufacturing. It helps identify critical processes and reduce extensive leachable testing.

Keywords:
AssessmentsExposure modelExtractables and leachablesSafetySingle-use systems

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Area of Science:

  • Biopharmaceutical Manufacturing
  • Chemical Engineering
  • Analytical Chemistry

Background:

  • Single-use systems in biopharmaceutical production raise concerns about leachables.
  • Effective mitigation strategies like process sinks and dilution exist.
  • Complex matrices in biopharmaceutical streams pose analytical challenges for leachable studies.

Purpose of the Study:

  • To present a modeling approach for assessing extractables and leachables.
  • To identify critical sources and low-risk components in biopharmaceutical processes.
  • To reduce the need for resource-intensive practical testing.

Main Methods:

  • Combining compound release and adsorption models.
  • Integrating dynamic process conditions of biopharmaceutical manufacturing.
  • Developing calculations to assess process criticality.

    • Main Results:

    • Identification of critical sources of leachables.
    • Pinpointing low-risk processes and components for extractables accumulation.
    • Demonstration of a predictive modeling approach.

    Conclusions:

    • The modeling approach effectively assesses risks associated with leachables.
    • This method significantly reduces the necessity for extensive leachable studies.
    • It offers a practical solution for managing extractables and leachables in biopharmaceutical manufacturing.