Facility will focus on rAAV clinical, commercial gene therapy products
Frontera Therapeutics held a groundbreaking ceremony to officially launch the construction of its Suzhou facility in bioBAY of Suzhou Industrial Park (SIP), Jiangsu, China. This 43,000 plus-square-foot property will be home to good manufacturing practice (GMP) cleanrooms for drug substance and drug product, GMP quality control testing labs, process development pilot plants and clinical testing labs. The facility is intended for the clinical manufacturing and the initial commercial manufacturing of Frontera's rAAV (recombinant adeno-associated virus) gene therapy products.
Dr. Yong Dai, co-founder and CEO of Frontera, thanked the leaders of SIPAC (Suzhou Industrial Park Administration Committee) and bioBAY for their support, as well as the investors for their trust. He mentioned that Frontera is looking to establish a cost-effective, scalable, local manufacturing platform in China to develop and produce affordably priced rAAV gene therapies for the Chinese market.
The rAAV gene therapy industry in China is up against challenges in chemistry, manufacturing and controls (CMC), such as optimizing production process and expanding the production scale for commercialization. Frontera has been working to create a team with experience surrounding rAAV product development, including research and preclinical development, CMC development and GMP manufacturing, clinical development, and regulatory filling.