Frontera Therapeutics Starts GMP Manufacturing Facility Construction

Frontera Therapeutics Starts GMP Manufacturing Facility Construction

SUZHOU, China, June 15, 2021 /PRNewswire/ — On June 9, 2021, Frontera Therapeutics Co., Ltd. (‘Frontera’) held a groundbreaking ceremony to start the construction of its Suzhou facility in bioBAY of Suzhou Industrial Park (SIP), Jiangsu, China. President of Suzhou Frontera, Dr. Xinyan Li, hosted the leaders of SIP and bioBAY, representatives of investors, and other guests who participated in this ceremony. This 4,000-square-meter 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. Director Ni said, “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. 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. Dr. 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 optimizing production process and expanding the production scale for the commercialization. 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 company’s rich pipeline programs.

About Frontera

Frontera was established by Creation Ventures and OrbiMed Advisors, which are renowned funds in the biotech industry. Frontera is an innovation-driven biotechnology company focused on developing and commercializing cost-effective rAAV-based gene therapies for the treatment of genetic disorders including those of the ophthalmology, liver, metabolic, and neuromuscular diseases. Relying on its industry-leading scientific research and management team and professionals with proven experience in gene therapy drug development and commercialization to build an extensive rAAV gene therapy pipeline targeting both rare and large-market indications to dramatically improve patients’ lives, Frontera has advanced several of its early pipeline programs to the preclinical development stage in less than one year.

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