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Activated Cross-linked Agarose for the Rapid Development of Affinity Chromatography Resins - Antibody Capture as a Case Study
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Microbiological Control for Affinity Capture Chromatography Processing: An Industry Perspective.

Marie Murphy1, Brian L Bell2, James Moshi3

  • 1Research Scientist, Microbiology/Virology, Operations, Eli Lilly&Co.

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|February 16, 2018
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Summary

This paper summarizes industry best practices for microbiological control in biopharmaceutical affinity chromatography. It details strategies for material, equipment, and storage to prevent microbial contamination of chromatography systems.

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Area of Science:

  • Biopharmaceutical Manufacturing
  • Microbiological Control
  • Chromatography

Background:

  • Historical concerns regarding microbial contamination in biopharmaceutical processing.
  • The critical role of chromatography in biopharmaceutical purification.
  • The need for robust microbial control strategies in sensitive manufacturing processes.

Purpose of the Study:

  • To summarize findings from a survey on microbiological control in affinity chromatography.
  • To outline industry-derived best practices for mitigating microbial contamination.
  • To provide guidance for enhancing microbial control and monitoring in chromatography systems.

Main Methods:

  • Industry-led survey conducted by the BioPhorus Operations Group (BPOG).
  • Compilation of historical microbiological control concerns.
  • Identification and synthesis of industry-derived best practices.

Main Results:

  • Summary of key microbiological control challenges in affinity chromatography.
  • Detailed best practices for material, equipment, and storage controls.
  • Guidelines to mitigate microbial ingress and contamination of chromatography resin and equipment.

Conclusions:

  • Enhanced microbial control is essential for biopharmaceutical manufacturing.
  • Industry best practices can significantly improve the safety and efficacy of chromatography processes.
  • The BPOG Bioburden Working Group provides valuable guidance for manufacturers.