GenScript Biotech Corporation, a 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. The latest expansion provides biopharma companies and gene and cell therapeutic discovery startups with components needed to advance novel therapies from the bench to the clinic.

The move positions GenScript as a top supplier with the capacity to help shorten the traditionally long wait times for crucial genetic material used to advance gene and cell therapies.

In a statement, GenScript said that it 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.

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.

The 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.”