The 8,000 sqm gene therapy-focused current good manufacturing practice (cGMP) production facility includes two drug substance production suites according to international standards
Neurophth Biotechnology, a fully-integrated genomic medicines company, has announced the opening of its state-of-the-art manufacturing facility at the Phase II Suzhou Biomedical Industrial Park (BioBAY) in Suzhou, China.
The 8,000 sqm gene therapy-focused current good manufacturing practice (cGMP) production facility includes two drug substance production suites, two filling lines, a cell banking suite, a technology transfer laboratory and a quality-control laboratory. Neurophth's proprietary manufacturing processes will take advantage of single-use equipment to aid in quick and effective product changeovers and equipment cleaning. The Suzhou facility has already employed over 100 employees.
"Neurophth's own cGMP production facility is designed to enable us to reach manufacturing scales suitable for future commercial production and the facility is also co-located with our development laboratories," said Bin Li, Chairman and Founder at Neurophth. "This integrated approach allows for more efficient development, manufacturing and release of vectors for new indications and we will continue to adhere to the patient-centric innovation and contribute to the development of Suzhou BioBAY."
Neurophth's own cGMP production facility is designed to enable us to reach manufacturing scales suitable for future commercial production
"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," said Alvin Luk, CEO of Neurophth. "This in-house 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. The fact that we're able to go from detailed design to construction completion in a year is remarkable. This was all made possible by our great support from government, our tireless team, our fantastic partners, and our terrific patients/families."
"Sequoia China, as an old friend of Neurophth, is pleased to see that the company's R&D, product and commercial layout progress are advancing rapidly with industry veterans continue to join the company," mentioned by Trency Gu, Managing Director of Sequoia China. "All of these positive progresses are testament to the strong executive team, innovation, clinical/regulatory and commercial ability. We look forward to supporting Neurophth, in the long run, to strengthen its innovation and lead China's ocular gene therapy products and ultimately benefit patients around the world."