Charles River and ASC Therapeutics expand gene therapy manufacturing agreement

By Rachel Arthur contact

- Last updated on GMT

Pic: getty/svetlanakrivenceva
Pic: getty/svetlanakrivenceva

Related tags: Charles river laboratories, Gene therapy, gene therapies, Hemophilia, Gene therapy candidate, Manufacturing

Charles River Laboratories International and ASC Therapeutics have announced plans to manufacture ASC618, a second-generation gene therapy for hemophilia A.

ASC618 is designed to deliver a shortened but optimized version of the F8 gene to liver cells (the gene is mutated in people with Hemophilia A, preventing them from producing a blood clotting protein).

Currently in pre-clinical trials, the gene therapy from California-headquartered ASC has received IND clearance and Fast Track Designation from the US FDA. 

In addition, the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion for an Orphan Medical Product Designation of ASC618.

New processes for AAV production and purification

ASC Therapeutics and Charles River have been working together since 2019 on GMP-virus manufacturing and have established processes for AAV production and purification.

“Together, Charles River and ASC Therapeutics have established a high-yield upstream process for AAV8 production, optimized the downstream purification methods to result in a more predictable drug product output, and fine-tuned a scalable manufacturing process in both upstream and downstream,”​ say the companies.

Charles River made a series of acquisitions in 2021, and the company says that through gaining Cognate BioServices, Cobra Biologics, and Vigene Biosciences it has enhanced its end-to-end CDMO capabilities. Its platforms now cover cell therapy, viral vector and plasmid DNA production.

Related news

Show more

Related products

Connectivity & Integration in Biomanufacturing

Connectivity & Integration in Biomanufacturing

Wheeler Bio | 17-Nov-2022 | Technical / White Paper

As the Pharma 4.0 initiative sets a new industry paradigm, more biomanufacturing companies are asking how they can design and build facilities that apply...

Scalability, Quality, and Speed with Transposons

Scalability, Quality, and Speed with Transposons

Wheeler Bio | 20-Oct-2022 | Technical / White Paper

To solve for the significant bottlenecks often presented by conventional cell line development processes, this article discusses how Wheeler Bio is leveraging...

Accelerating Time to IND with Pharma 4.0

Accelerating Time to IND with Pharma 4.0

Wheeler Bio | 22-Sep-2022 | Technical / White Paper

The future of the biopharmaceutical industry hinges on its adoption of 21st-century digital tools and automation.

Discover the world of upstream bioprocessing

Discover the world of upstream bioprocessing

Eppendorf Bioprocess Solutions | 07-Sep-2022 | Technical / White Paper

A must-read for all bioprocess scientists: This bundle of four ebooks created by Eppendorf guides you through the world of upstream bioprocessing.

Follow us


View more