Gritgen Therapeutics Co., Ltd., a biotechnology company specializing in the discovery and development of cutting-edge gene therapy products, is pleased to announce the successful validation and official commencement of operations at its commercial Good Manufacturing Practices (GMP) facility located in Suzhou Industrial Park. This milestone paves the way for the production of Gritgen's phase III clinical and commercial product for hemophilia A (HA). The construction of the GMP facility aligns closely with global cGMP standards and adheres to regulatory guidelines established by authoritative agencies, including the NMPA, FDA, and EMA. Consequently, it stands as a premier commercial facility for AAV-based products in China.

The GMP facility boasts an impressive 8,600 square meters, encompassing plasmid production and AAV production lines. The production lines are built upon a mature and reliable upstream process that employs mammalian cell suspension. The downstream process leverages chromatography platform technology and incorporates disposable bioreactors of various sizes, with the largest scale reaching 1,000 liters. This meticulous approach ensures productivity and manufacturing quality. The facility is equipped with pilot filling lines and commercial fill-finish lines to meet drug product manufacturing requirements. A quality control laboratory is also on-site, facilitating biochemical, physicochemical, molecular biological, and microbiological tests. The production lines in the facility are physically separated, effectively mitigating the risk of cross-contamination and forming the bedrock for a robust global supply chain for innovative gene therapy products.

Dr. Wu Fenglan, Co-founder and CEO of Gritgen, commented, "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 in gene therapy is the manufacturing process, a challenge resonating globally. The production capacity of large-scale, high-quality, cost-controllable vectors is an important driving force for the development of the gene therapy industry."

Gritgen is committed to making its mark as a "China-based, world-leading" biotechnology company, actively engaging in global clinical development and commercialization of a portfolio of flagship gene therapy products. With its industry-leading expertise, innovative technology platforms, and cutting-edge facilities, the company strives to introduce more first-in-class and best-in-class gene therapy drugs to patients worldwide.