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Related Experiment Video

Updated: Oct 8, 2025

Author Spotlight: Advancing Gene Therapy Research with High-Titer Adeno-Associated Virus Vector Production
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Leveraging high-throughput purification to accelerate viral vector process development.

Xiaotong Fu1, Asher Williams1, Meisam Bakhshayeshi1

  • 1Gene Therapy Process Development, Biogen, 225 Binney St, Cambridge, MA 02142, United States.

Journal of Chromatography. A
|December 31, 2021
PubMed
Summary
This summary is machine-generated.

High throughput (HTP) chromatography accelerates gene therapy development by enabling faster purification process optimization for adeno-associated virus (AAV) vectors. This HTP platform reduces material needs and timelines for clinical applications.

Keywords:
Adeno-associated virus (AAV)Gene therapyHigh throughput (HTP) chromatographyPurification

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Area of Science:

  • Biotechnology
  • Gene Therapy
  • Process Development

Background:

  • Recombinant adeno-associated virus (AAV) is a key delivery vector for gene therapies.
  • Developing robust and scalable purification processes for AAV is critical for clinical translation.
  • Early-stage development faces challenges due to limited timelines and materials.

Purpose of the Study:

  • To establish and validate a high throughput (HTP) chromatography platform for adeno-associated virus (AAV) purification process development.
  • To demonstrate the utility of HTP strategies in overcoming limitations in gene therapy vector purification.
  • To provide a detailed workflow for HTP AAV purification to guide future development.

Main Methods:

  • Development of an end-to-end HTP chromatography platform using mini-columns and self-packed resin plates.
  • Comparison of process performance between HTP and traditional bench-scale chromatography.
  • Evaluation of recovery, full capsid enrichment, and impurity clearance.

Main Results:

  • Comparable impurity clearance was achieved between HTP and bench-scale chromatography.
  • HTP format showed slightly lower recovery (62% vs. 75%) and %full capsid enrichment (71% vs. 82%) compared to bench-scale.
  • The HTP platform demonstrated its capability to facilitate gene therapy purification development.

Conclusions:

  • The established HTP chromatography platform can effectively serve as a surrogate for bench-scale development in adeno-associated virus (AAV) purification.
  • HTP approaches significantly reduce material requirements and development timelines for gene therapy vector purification.
  • This work provides a foundational workflow for implementing HTP strategies in AAV purification development.