Frontera Therapeutics starts GMP facility construction

Published: 21-Jun-2021

This 4,000 sqm facility in China has been designed for the clinical manufacturing and the initial commercial manufacturing of Frontera's rAAV gene therapy products

Frontera Therapeutics has held a groundbreaking ceremony to start the construction of its Suzhou facility in bioBAY of Suzhou Industrial Park (SIP), Jiangsu, China.

This 4,000 sqm premises will house the GMP manufacturing cleanrooms for drug substance and drug product, the GMP quality control testing labs, the process development pilot plants, and the clinical testing labs. This facility is designed for the clinical manufacturing and the initial commercial manufacturing of Frontera's rAAV gene therapy products.

Ni Qian, Vice Director of Suzhou Industrial Park Administration Committee (SIPAC), delivered a warm congratulatory speech on behalf of SIPAC. Ni said: "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."

Dr Yong Dai, co-founder and CEO of Frontera expressed his gratitude to the leaders of SIPAC and bioBAY for their strong support as well as the investors for their trust.

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Dai pointed out that Frontera aspires to establish the 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 optimising production process and expanding the production scale for commercialisation.

Frontera has rapidly built up a world-class team with extensive experiences of the rAAV product development, consisting of research and preclinical development, CMC development and GMP manufacturing, clinical development, and regulatory filling talents. The team has been working collaboratively and has demonstrated amazing speed to achieve critical milestones of the company's rich pipeline programmes.

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