GenScript Doubles cGMP sgRNA and Non-Viral DNA Payload Manufacturing Capacity
Additional 400,000 sq.ft. at GenScript's cGMP facility in Zhenjiang, China gives biopharma companies and gene/cell therapeutic discovery startups fast access to synthetic CRISPR sgRNA and non-viral single and double-stranded DNA payloads
PISCATAWAY, N.J., July 6, 2023 /PRNewswire/ -- GenScript Biotech Corporation, the world's leading provider of life-science research tools and services, has expanded its cGMP manufacturing capacity for sgRNA and non-viral DNA payloads with a new, state-of-the-art facility in Zhenjiang, Jiangsu, China. This latest expansion provides biopharma companies and gene and cell therapeutic discovery startups a fast-turnaround source of the quality components needed to advance novel therapies from the bench to the clinic and onto the market in less time.
"As a researcher in the gene and cell therapy field, I have experienced firsthand the challenges of finding GMP-grade materials for editing cells. In our lab, we have been leveraging non-viral CRISPR and payload materials to efficiently reprogram various types of immune cells, due to multiple advantages non-viral materials possess, including increased payload capacity, cost reduction, and accelerated timelines," said Brian Shy, MD, PhD, HS, clinical instructor of laboratory medicine and HICTF medical director at UCSF. "With the rapid growth of this field, the need for non-viral GMP reagents has become increasingly urgent. This new facility has the potential to enable researchers like us to move into clinical studies faster and more affordably, bringing us closer to developing life-changing therapies for patients in need."
The move by GenScript, a market leader in the synthesis of cGMP-quality CRISPR sgRNA and HDR (homology-directed repair) templates, positions GenScript as the top supplier with the capacity to shorten the traditionally long wait times for crucial genetic material used to advance life-saving gene and cell therapies — and to reduce the significant financial risk undertaken by the companies that develop such therapies. GenScript has a proven track record of providing cGMP-quality sgRNA and non-viral DNA payloads, along with full batch records, documentation, and the regulatory support needed for gene- and cell-therapy development and successful IND filing.
GenScript's ongoing commitment to meet the needs of research scientists
In 2020, GenScript established a 21,500 sq. ft. cGMP plant in Nanjing, comprising five cGMP production lines for synthetic CRISPR sgRNA and non-viral DNA payloads. As of April 2023, GenScript has delivered 56 batches of cGMP quality gene editing products to global biotechnology and pharmaceutical companies in the gene and cell therapy field, supporting 18 project applications, five of which have received IND approvals.
This recent expansion adds 400,000 sq.ft. of cGMP manufacturing space in Zhenjiang, bringing onstream four additional production lines equipped to deliver up to gram quantities of sgRNA or hundreds of milligrams of ssDNA or dsDNA per batch, respectively, with superior purity.
"GenScript is pleased to complete the expansion of our manufacturing capacity of cGMP sgRNA and non-viral DNA payloads for IND filing and clinical trials," said Ray Chen, president of the Life Science Group at GenScript. "Over the past several years, in response to the increased demand we are seeing worldwide, GenScript has invested heavily in a broad array of reagent services, enabling our customers to advance their gene- and cell-therapy pipelines. The opening of our newest cGMP manufacturing facility represents our strong commitment to supporting our gene and cell therapy customers."
"The new Zhenjiang state-of-art cGMP facility has been designed and qualified to meet the GMP requirements of major regulatory authorities such as FDA, EMA, PMDA and NMPA. GenScript has established a phase-appropriate cGMP system including a material system, a facilities & equipment system, a laboratory control system, a production system, and a packaging and labeling system, which are all integrated into the quality system," said Luc Ruelens, GMP project lead at GenScript. "The last manufacturing aseptic fill step is done in a customized Grade A isolator. The facility, sterile filtration, and aseptic processes have been validated according to the regulatory guidelines and industry standards.
Where to learn more
Watch GenScript's new cGMP facility video
Visit the GenScript cGMP sgRNA microsite
Visit the GenScript cGMP ssDNA and dsDNA microsite
About GenScript Biotech Corporation
GenScript Biotech Corporation (HK:1548) is the world's leading technology and service provider of life-science R&D and manufacture. Built upon its solid gene synthesis technology, GenScript Biotech is divided into four major platforms: the life-science service and product platform, the biologics contract development and manufacturing organization (CDMO) platform, the industrial synthetic products platform, and the integrated global cell therapy platform.
GenScript Biotech was founded in New Jersey, US in 2002 and listed on the Hong Kong Stock Exchange in 2015. GenScript Biotech's business operations span over 100 countries and regions worldwide with legal entities located in the US, Mainland China, Hong Kong, China, Japan, Singapore, Netherlands, Ireland, the United Kingdom, Korea, and Belgium. GenScript Biotech provides premium, convenient and reliable services and products for over 200,000 customers.
As of December 31, 2022, GenScript Biotech had more than 6,000 employees globally, over 37% of whom hold master's and/or Ph.D. degrees. In addition, GenScript Biotech owns numerous intellectual property rights, including over 210 patents, over 800 pending patent applications and great numbers of trade secrets.
Driven by the corporate mission of "make people and nature healthier through biotechnology," GenScript Biotech strives to become the most trustworthy biotech company in the world. As of December 31, 2022, 76,000 peer-reviewed journal articles worldwide have cited GenScript Biotech's services and products. For more information, please visit GenScript Biotech's official website genscript.com.
Media contact
Tim Cox — ZingPR for GenScript
tim@zingpr.com
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SOURCE GenScript Biotech Corporation
