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Author Spotlight: Advancing Gene Therapy Research with High-Titer Adeno-Associated Virus Vector Production

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Manufacturing Challenges and Rational Formulation Development for AAV Viral Vectors.

Arvind Srivastava¹, Krishna M G Mallela², Nandkumar Deorkar¹

¹Biopharma Production, Avantor, Inc., 1013 US Highway, 202/206, Bridgewater, NJ, United States.

Journal of Pharmaceutical Sciences

|April 4, 2021

Summary

Adeno-associated virus (AAV) production faces challenges in yield and shelf-life. This review details manufacturing issues and formulation strategies to enhance AAV vector quality and stability.

Keywords:

AAV Antioxidants Chemical stability Deamidation Excipients Formulation Oxidation Physical stability Viral vector

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Area of Science:

Biotechnology
Gene Therapy
Biopharmaceutical Manufacturing

Background:

Adeno-associated virus (AAV) vectors are crucial for gene therapy due to their safety and efficacy.
Current AAV manufacturing yields and shelf-life lag behind recombinant protein therapeutics.
Challenges exist in large-scale production, purification, and long-term storage of AAV vectors.

Purpose of the Study:

To comprehensively analyze challenges in AAV vector manufacturing (upstream, downstream, formulation).
To discuss strategies for maintaining AAV product quality throughout shelf-life.
To highlight degradation mechanisms and formulation approaches for AAV stability.

Main Methods:

Review of scientific literature on AAV manufacturing processes.
Analysis of physical and chemical instability mechanisms under various stress conditions (thermal, shear, freeze-thaw, light).
Discussion of the impact of buffer composition, pH, excipients, and impurities on viral vector stability.

Main Results:

Identified key challenges in upstream, downstream, and formulation unit operations for AAV production.
Detailed mechanisms of AAV degradation due to thermal, shear, freeze-thaw, and light stress.
Emphasized the critical role of buffer conditions, pH, excipients, and impurities in AAV stability.

Conclusions:

A mechanistic understanding of AAV degradation is essential for improving product quality.
Formulation strategies and process optimization are key to enhancing AAV vector stability and shelf-life.
This review provides a roadmap for advancing the quality of AAV-based gene therapy products.