Open-Source Lentiviral Vector and Adenoviral-Associated Viral Vector Manufacturing Platforms

The purpose of this project is to establish open-source viral vector manufacturing platforms for adeno-associated virus (AAV) and lentivirus (LV).

Industry Need

Vector manufacturing is a major bottleneck in biopharmaceutical manufacturing.
The availability of an open platform process will ease the burden and the timeframe required for any one organization to innovate their own unique therapeutic or vaccine and will provide a basis for collaborative innovation.

Solution

Caring Cross aims to establish open-source viral vector manufacturing platforms for adeno-associated virus (AAV) and lentivirus (LV).

AAV and LV can be used in a variety of contexts including for vaccines and therapeutics to prepare for and respond to coronavirus. The processes in this project will be developed from first principles and published methods, and then be iteratively developed into a complete and robust manufacturing process.

The project will involve:

The project will use HEK-293 cells in chemically defined serum-free suspension culture.
Transfection methods for both the AAV and LV processes will be common and could potentially be used as a basis to manufacture other viral vectors of interest.
Assays will be developed to measure key product characteristics—such as titer, identity, and stability—that will be run in-house and could easily be transferred to a partner facility or modified to measure other viral vectors.

Separately, the team will identify and list assays that are necessary but are best performed at a vendor site due to complexity and necessary expertise, such as sterility, adventitious virus testing, RCL, etc.

Outcomes and Impacts

Reference standards for LV and AAV will be manufactured and characterized by Caring Cross and collaborators for release. All processes, methods, assays, materials, etc. generated in this project will be made publicly available through Caring Cross and NIIMBL.

An open platform production process for LV and AAV will be made available that can be used as a starting point for the manufacture of medicines and vaccines to respond to coronavirus.

The open platform will remove a large barrier to production and enable faster response by large and small companies and academic/non-profit organizations.

Updates, Related Publications, and Deliverables

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Project Lead

Caring Cross, Inc.