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Towards a Platform Chromatography Purification Process for Adeno-Associated Virus (AAV).

Alexandra Bogdanovic1,2,3, Nicholas Donohue1, Brian Glennon1,2

  • 1APC Ltd, Dublin, Ireland.

Biotechnology Journal
|January 16, 2025
PubMed
Summary

Developing a Good Manufacturing Practice (GMP)-ready platform for adeno-associated virus (AAV) purification is crucial. This review explores chromatography strategies and AAV characteristics for standardized, high-purity viral vector production.

Keywords:
adeno‐associated viruschromatographyplatform process

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Area of Science:

  • Biotechnology and Viral Vector Manufacturing
  • Downstream Processing and Purification Technologies

Background:

  • Adeno-associated virus (AAV) is a key viral vector for gene therapy and vaccines.
  • Standardized Good Manufacturing Practice (GMP)-ready downstream processing is a major hurdle in AAV production.
  • Chromatography offers a scalable solution for high-purity, potent, and consistent AAV manufacturing.

Purpose of the Study:

  • To review critical factors for developing a GMP-ready chromatography platform for AAV purification.
  • To comprehensively analyze chromatography types, formats, and operational modes for AAV processing.
  • To integrate AAV characteristics with chromatography platform development considerations.

Main Methods:

  • Literature review of chromatography techniques applicable to viral vector purification.
  • Analysis of AAV properties including surface charge, structure, size, and interactions.
  • Evaluation of commercial considerations in chromatography platform development.

Main Results:

  • Chromatography is a scalable and effective method for achieving high-purity AAV.
  • Key factors for platform development include chromatography type, format, and mode of operation.
  • Understanding AAV characteristics (charge, size, interactions) is vital for optimizing purification.

Conclusions:

  • A standardized, GMP-ready chromatography platform is essential for efficient AAV production.
  • Integrating AAV properties with chromatography design enables robust and reproducible manufacturing.
  • This review provides a framework for developing advanced AAV purification strategies.