Neurophth Announces the Completion of GMP Manufacturing Facility for Gene Therapy Products According to International Standards
Source:   Release Date: 2021-09-28


SUZHOU and SAN DIEGO, September 27, 2021 – Neurophth Biotechnology Ltd., a fully-integrated genomic medicines company seeking to improve lives through the curative potential of gene therapies, 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 square-meter 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.”


“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, Chief Executive Officer 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.”


Qian Ni, member of the Working Committee and Deputy Director of the Management Committee of Suzhou BioBAY, delivered a speech at the commissioning ceremony saying, “Biomedicine is one of the most explosive emerging industries in the world, and it is also an important starting point for Suzhou BioBAY to accelerate the cultivation of new innovation. Now, Suzhou BioBAY has ushered in a ‘harvest season’ and a number of champions have emerged, becoming one of the biomedical professional parks with the highest development level and the strongest competitiveness in China. I sincerely congratulate Neurophth on its milestone, and sincerely look forward to Neurophth forging ahead, deeply cultivating the industrial park, and supporting the development of Suzhou BioBAY to a higher level.”