SUZHOU, China--(BUSINESS WIRE)--Gritgen Therapeutics Co., Ltd. (“Gritgen”), a biotechnology company focused on discovering and developing innovative gene therapy products, announces the successful validation and official launching of operations at its commercial GMP facility located in Suzhou Industrial Park. This achievement sets the stage for the production of Gritgen's phase III clinical and commercial product for hemophilia A (HA). The construction of Gritgen's GMP facility strictly adheres to the global cGMP standards, and complies with the regulatory guidelines of authoritative agencies including the NMPA, the FDA and the EMA. It is now a leading commercial facility for AAV-based products in China.
The facility has 8,600 square meters, covering plasmid production and AAV production lines. The production lines are based on a mature and reliable upstream process with mammalian cell suspension, and downstream process with chromatography platform technology, equipped with disposable bioreactors of different scales, of which the largest scale reaches 1,000 liters, taking into account of the productivity and quality of manufacturing. The facility is equipped with pilot filling lines and commercial fill-finish lines to meet the need of drug product manufacture. The facility also has a quality control laboratory covering biochemical, physicochemical, molecular biological, and microbiological tests. Production lines in the facility are completely physically separated, which comprehensively controls the risk of cross-contamination, and lays a solid foundation for the global supply chain guarantee of innovative gene therapy products.
Dr. Wu Fenglan, Co-founder and CEO of Gritgen, stated, “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 the present, a bottleneck of 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 gene therapy industry."
Embarking on the concept to establish a “China-based, world-leading” biotechnology company, Gritgen is actively venturing into the worldwide arena of clinical development and commercialization for a portfolio of flagship gene therapy products. Powered by industry-leading intense expertise, innovative technology platforms, and state-of-the-art facilities, the company is committed to introducing more first-in-class and best-in-class gene therapy drugs to global patients.
Founded in 2019 by Dr. Yi Rao, a leader of biomedical research in China, Gritgen is dedicated to apply “Great Science for Human Health”. The company has independently developed globally leading highly efficient GritPAC and GritOcul platforms. Combining fundamental understanding of genetics and biology of diseases with modern technologies in molecular biology, Gritgen develops multiple product pipelines in rare and common diseases to fulfill the unmet medical needs of patients and improve the health of people in China and the world.