Neurophth Biotechnology has opened a gene therapy manufacturing plant at Suzhou Biomedical industrial park (BioBay) in China, eliminating dependence on CDMOs.
Neurophth claims to be China’s first gene therapy firm for ophthalmic diseases headquartered in Wuhan with subsidiaries located in Shanghai and Suzhou, China, and San Diego, California.
The recently opened 8,000 square meter gene therapy-focused manufacturing facility includes two drug substance production suites, a cell banking suite, two filling lines, a technology transfer laboratory, and a quality control laboratory.
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The plant went from design to completion in a year and Neurophth has already employed over 100 members of staff at its Suzhou plant.
According to the firm, it will take advantage of single-use equipment to support fast and effective product changeovers and equipment cleaning. Additionally, the company claims the facility adds to its inhouse manufacturing capacity, removing the dependence on CDMOs.
“One of our key strategic priorities at Neurophth is to create gene therapies that can be manufactured consistently and rapidly while maintaining the international highest quality,” Alvin Luk, CEO at Neurophth said.
“This inhouse production capacity eliminates the dependence on CDMO which will allow us to bring products of our 10+ programs seamlessly from research stage to the clinic and ultimately to patients faster.”
While bioprocessing contract manufacturing organizations (CMOs) in China are increasing with firms like Lonza expanding in the region rapidly, Vicky Xia from BioPlan says there is still a strong preference in China for inhouse production.
In CPhI’s annual report 2021, Xia says China’s preference for inhouse manufacturing “puts the future of China-based biologics CDMOs at particularly poignant moment. Many industry analysts doubt if China really needs so many biologics CDMOs and foresee a period of mergers and acquisitions in the near future.”
She added: “Few domestic developers have turned to external partners for commercial scale biomanufacturing. In fact, BioPlan’s internal studies reported only nine commercial scale contract manufacturing deals with China-based CMOs, among which the majority are for WuXi Biologics.”
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