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A High-throughput Automation Platform For Accelerated Aav Stability Optimization.

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A High-throughput Automation Platform For Accelerated Aav Stability Optimization.

Related Experiment Video

A Streamlined and Standardized Procedure for Generating High-Titer, High-Quality Adeno-Associated Virus Vectors Utilizing a Cell Factory Platform

A Streamlined and Standardized Procedure for Generating High-Titer, High-Quality Adeno-Associated Virus Vectors Utilizing a Cell Factory Platform

Published on: May 3, 2024

A High-Throughput Automation Platform for Accelerated AAV Stability Optimization.

Shuai Li¹, Xiaoyan Wang¹, Li Zhi¹

¹Drug Product Development and Technology, Regeneron Pharmaceuticals Inc., Tarrytown, NY 10591, USA.

|May 27, 2026

View abstract on PubMed

Summary

This summary is machine-generated.

A new automated platform rapidly develops stable adeno-associated virus (AAV) formulations for gene therapy. This high-throughput system screens numerous conditions to quickly identify optimal, stable AAV formulations.

Keywords:

AAV automation formulation high-throughput screening

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AAV Deployment of Enhancer-Based Expression Constructs In Vivo in Mouse Brain

AAV Deployment of Enhancer-Based Expression Constructs In Vivo in Mouse Brain

Published on: March 31, 2022

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AAV Deployment of Enhancer-Based Expression Constructs In Vivo in Mouse Brain

AAV Deployment of Enhancer-Based Expression Constructs In Vivo in Mouse Brain

Published on: March 31, 2022

Area of Science:

Gene therapy
Biopharmaceutical formulation
Recombinant adeno-associated virus (AAV) vector development

Background:

Stable adeno-associated virus (AAV) formulations are crucial for advancing gene therapy applications.
Diverse AAV serotypes and engineered capsids present formulation development challenges.
Traditional manual methods are insufficient for rapid characterization of large formulation design spaces.

Purpose of the Study:

To develop an innovative, high-throughput automation platform for efficient AAV formulation development.
To accelerate the discovery of stable AAV formulations.
To enable rapid characterization of extensive formulation design spaces.

Main Methods:

Implemented a high-throughput automation platform for rapid formulation preparation and AAV analytics.

The system prepares 96 distinct formulations in 40 minutes and completes AAV compounding in 20 minutes per plate.

Precise control over pH, buffer components, and AAV titers was maintained throughout the process.

Main Results:

Screened 128 formulations for AAV1 across various buffer systems, pH ranges, and excipient combinations.
Identified optimal stable high-titer AAV1 formulations (1.2 × 10^14 vg/mL).
Formulations demonstrated stability under frozen, refrigerated, and room temperature storage conditions.

Conclusions:

The automation platform significantly accelerates AAV formulation development.
This approach conserves valuable AAV material and enables systematic exploration of the formulation design space.
Robust and stable AAV formulations were identified in a timeframe significantly shorter than traditional methods.