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.