Neurophth Announces the Completion of GMP Manufacturing Facility for Gene Therapy Products According to International Standards

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Neurophth's proprietary manufacturing processes will take advantage of single-use equipment to aid in quick and effective product changeovers and equipment cleaning.

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PR NewswirePR Newswire
Retrieved on: 
Monday, September 27, 2021
Information
Tags: 
Retina, ODD, Scientific Reports, Union of Agricultural Work Committees, CDMO, IgG4-related ophthalmic disease, Speech, CGMP, FDA, Multimedia, Patient, Phase, SAN, Congress Working Committee, Biotechnology, Diabetic retinopathy, IND, EBioMedicine, LHON, Laboratory, AAV, Glaucoma, Technology transfer, Government, Bolam v Friern Hospital Management Committee, Pharmaceutical industry, Fine chemical
Geotags: 
China, California, US, WUHAN, SAN DIEGO, SUZHOU, SHANGHAI
Organisation: 
NEUROPHTH THERAPEUTICS, INC.
Summary
Key Points: 
  • Neurophth's proprietary manufacturing processes will take advantage of single-use equipment to aid in quick and effective product changeovers and equipment cleaning.
  • "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.
  • 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."
  • Neurophth has initiated the scaling up in-house manufacturing process in single-use technologies to support future commercial demand at the Suzhou facilities.


Neurophth Announces the Completion of GMP Manufacturing Facility for Gene Therapy Products According to International Standards

WUHAN, China and SAN DIEGO, Sept. 27, 2021 /PRNewswire/ -- 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."

About Neurophth

Neurophth is China's first gene therapy company for ophthalmic diseases.  Headquartered in Wuhan with subsidiaries in China (Shanghai and Suzhou) and US (San Diego, California), Neurophth, a fully integrated company, is striving to discover and develop gene therapies for patients suffering from genetic diseases globally. Our validated AAV platform, which has been published in Nature - Scientific Reports, Ophthalmology, and EBioMedicine, has successfully delivered proof-of-concept investigator-initiated trials data of 198 subjects with investigational gene therapies in the retina. Our most advanced investigational candidate, NR082 (NFS-01 project, rAAV2-ND4), in development for the treatment of ND4-mediated Leber hereditary optic neuropathy (LHON), has been granted orphan drug designation (ODD) by the U.S. FDA and its IND evaluating NR082 in a Phase 1/2/3 clinical trial has also been approved by the China NMPA in March 2021 with the first patient being dosed in June 2021. The pipeline also includes ND1-mediated LHON, autosomal dominant optic atrophy, optic neuroprotection (e.g., glaucoma), vascular retinopathy (e.g., diabetic retinopathy), and five other preclinical candidates.  Neurophth has initiated the scaling up in-house manufacturing process in single-use technologies to support future commercial demand at the Suzhou facilities. To learn more about us and our growing pipeline, visit www.neurophth.com.

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SOURCE Neurophth Therapeutics, Inc.

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