GenScript Production Capacity Expanded

GenScript Doubles cGMP sgRNA and Non-Viral DNA Payload Manufacturing Capacity GenScript Biotech Corporation, the leading supplier of life-science research tools and services, has expanded its cGMP manufacturing capacity for sgRNA and non-viral DNA payloads through the construction of a state-of-the-art facility in Zhenjiang, Jiangsu, China. This expansion provides biopharma companies and early-stage startups researching gene and cell therapies with a reliable source for high-quality components to advance novel therapies from laboratory to clinic and market more rapidly. "As a researcher in the gene and cell therapy field, I have experienced firsthand the challenges of finding GMP-grade materials for cell editing. In our laboratory, we have been using non-viral CRISPR and payload materials to efficiently reprogram various types of immune cells, owing to multiple advantages non-viral materials offer, 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 rapid growth in 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." GenScript's position as a market leader in cGMP-quality CRISPR sgRNA and HDR (homology-directed repair) template synthesis now positions the company as the leading supplier capable of reducing lengthy wait times for essential genetic material used to advance gene and cell therapies—and lowering the significant financial risk assumed by therapy-developing companies. GenScript has a track record of supplying cGMP-quality non-viral DNA payloads and sgRNA, complete batch records, documentation, and regulatory support required for gene- and cell-therapy product development and successful IND filing.

GenScript's ongoing commitment to meeting research scientists' needs

GenScript established a 21,500 square foot cGMP facility with five cGMP production lines for synthetic CRISPR sgRNA and non-viral DNA payloads in Nanjing in 2020. As of April 2023, GenScript had delivered 56 batches of cGMP-quality gene editing products to international biotechnology and pharmaceutical companies in gene and cell therapy to support 18 project applications, five of which have received IND approvals. The recent expansion in Zhenjiang adds 400,000 square feet of cGMP manufacturing space. Four additional production lines are now operational, each capable of producing up to one gram of high-purity sgRNA per batch or hundreds of milligrams of ssDNA or dsDNA per batch. "GenScript is pleased to complete the expansion of our manufacturing capacity for 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 increased worldwide demand, GenScript has invested heavily in a broad range 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-the-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, facilities and equipment system, laboratory control system, production system, and packaging and labeling system, all integrated into the quality system," said Luc Ruelens, GMP project lead at GenScript. The final aseptic fill manufacturing step is completed in a customized Grade A isolator. The facility, sterile filtration, and aseptic processes have been validated according to regulatory guidelines and industry standards. Note: Content may be edited for style and length. Source