Gritgen validates China plant as it advances hemophilia A gene therapy

Suzhou Gritgen Therapeutics has opened a commercial gene therapy facility in Suzhou Industrial Park, China.

Gritgen develops adeno associated virus (AAV) gene therapies, with its next-gen AAV capsid platform and efficient promotors and enhancers. The GMP facility is built to comply with global cGMP standards, including the NMPA, the FDA and the EMA.

The 8,600 square-meter manufacturing facility will house plasmid production and AAV production lines. The production lines are based on a reliable upstream process with mammalian cell suspension and a downstream process with chromatography platform technology, offering disposable bioreactors of different scales – the largest bioreactor is 1,000 L.

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The facility will also contain pilot filling lines and commercial fill-finish lines to meet the need of drug product manufacture. The facility’s quality control laboratory offers biochemical, physicochemical, molecular biological, and microbiological tests that are separated from production lines to control cross-contamination risk.

Initially, the company will use the facility to produce Phase III clinical and commercial supplies for its lead candidate, a gene therapy for hemophilia A. But besides the hemophilia A product, Gritgen has a gene therapy for hereditary angioedema in IND-enabling studies. The company’s website also lists an additional nine candidates in preclinical development, three of them for rare diseases and the rest for common diseases. It does not offer any additional description of these projects.

Wu Fenglan, CEO of Gritgen, said, “The validation and operational launch of our GMP facility represents a pivotal juncture for Gritgen, which provides an important vector foundation for the company to realize commercialization. At present, a bottleneck of gene therapy is the manufacturing process, a challenge resonating globally. Our production capacity of large-scale, high-quality, cost controllable vectors is an important driving force for the development of gene therapy industry.”

A version of this article was first published in ChinaBio Today on October 11, 2023