OR WAIT null SECS
The construction of Gritgen’s GMP facility strictly adheres to the global current GMP (CGMP) standards and complies with the regulatory guidelines of authoritative agencies including the National Medical Products Administration (NMPA), FDA, and the European Medicines Agency (EMA).
Gritgen Therapeutics, a biotechnology company focused on gene therapy products, announced the successful validation and official launch of operations at its commercial good manufacturing practice (GMP) facility located in Suzhou Industrial Park. According to the press release, the milestone sets the stage for the development of Gritgen’s Phase III clinical and commercial product for hemophilia A (HA). Further, the construction of Gritgen’s GMP facility strictly adheres to the global current GMP (CGMP) standards and complies with the regulatory guidelines of authoritative agencies including the National Medical Products Administration (NMPA), FDA, and the European Medicines Agency (EMA).
The new facility is 8600 square meters and covers plasmid production and AAV production lines. In addition, the production lines are based on a mature and reliable upstream process with mammalian cell suspension, and a downstream process with chromatography platform technology, equipped with disposable bioreactors of different scales (the largest scale reaches 1000 liters).
According to the press release, the facility is equipped with pilot filling lines and commercial fill/finish lines to meet the need of drug product manufacture, and has a quality control laboratory covering biochemical, physicochemical, molecular biological, and microbiological tests. The production lines in the facility also are completely physically separated, which comprehensively controls the risk of cross-contamination and is a solid foundation for the global supply chain guarantee of innovative gene therapy products.
“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,” said Dr. Wu Fenglan, co-founder and CEO of Gritgen, in a press release. “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."