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

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.