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Designed for clinical manufacturing and initial commercial manufacturing of rAAV gene therapy products.
June 23, 2021
By: Tim Wright
Editor-in-Chief, Contract Pharma
Frontera Therapeutics held a groundbreaking ceremony to start the construction of its Suzhou facility in bioBAY of Suzhou Industrial Park (SIP), Jiangsu, China. This 4,000-square-meter site will house GMP manufacturing cleanrooms for drug substance and drug product, GMP quality control testing labs, process development pilot plants, and clinical testing labs. This facility is designed for clinical manufacturing and the initial commercial manufacturing of Frontera’s rAAV gene therapy products. “Frontera is an innovative international gene therapeutics company, bearing the mission of bringing treatment solutions to patients in China as well as in the world,” said Ni Qian, vice director of Suzhou Industrial Park Administration Committee (SIPAC). “Frontera has made rapid progress and remarkable achievements in less than one year, as multiple products have already been advanced to the preclinical development stage.” Yong Dai, co-Founder and CEO of Frontera expressed his gratitude to the leaders of SIPAC, bioBAY and investors. Dr. Dai pointed out that Frontera aspires to establish a cost-effective, scalable, local manufacturing platform in China to develop and produce high quality, affordably priced rAAV gene therapies for the China market. The emerging rAAV gene therapy industry in China is facing great challenges in Chemistry, Manufacturing and Controls (CMC), including optimizing production process and expanding production scale for commercialization.
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