Gritgen Therapeutics Co., a biotechnology company focused on gene therapy products, reported the successful validation and launch of operations at its commercial GMP facility in Suzhou China for the production of Gritgen’s phase III clinical and commercial product for hemophilia A. The construction of Gritgen’s GMP facility adheres to the global cGMP standards and complies with the regulatory guidelines of authoritative agencies including the NMPA, the FDA and the EMA.
The 8,600 square meter facility covers plasmid production and AAV production lines. The production lines are based on a mature upstream process with mammalian cell suspension, and downstream process with chromatography platform technology, equipped with disposable bioreactors of different scales. The largest scale reaches 1,000 liters, taking into account of the productivity and quality of manufacturing.
It 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.
Wu Fenglan, Co-founder, and 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 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.”