GenScript Expands DNA Payload Production Capacity

GenScript Expands DNA Payload Production Capacity GenScript Doubles cGMP sgRNA and Non-Viral DNA Payload Production Capacity. GenScript Biotech Corporation, a leading provider of life science research tools and services worldwide, has expanded cGMP production capacity for sgRNA and non-viral DNA payloads with a state-of-the-art new facility in Zhenjiang, Jiangsu province, China. This latest expansion provides biopharmaceutical companies and gene and cell therapeutic discovery initiatives with a reliable source of quality components to advance new treatments from the bench to the clinic and market in shorter timeframes. Brian Shy, laboratory medicine clinical educator and medical director of HICTF at UCSF, (MD, PhD, HS) stated: "As a researcher in the field of gene and cell therapy, I have firsthand experience with the challenges of finding GMP-grade materials to engineer cells. In our laboratory, we leverage non-viral CRISPR and payload materials to efficiently reprogram various immune cell types because of the many advantages non-viral materials offer, including increased payload capacity, cost reduction and accelerated timelines. 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 transition to clinical trials faster and more cost-effectively, bringing us closer to developing life-changing therapies for patients in need." As a market leader in the synthesis of CRISPR sgRNA and HDR (homology-directed repair) templates at cGMP quality, GenScript's move positions the company as the best supplier capable of shortening the traditionally long wait times for critical genetic material used to advance life-saving gene and cell therapies and reducing the significant financial risk assumed by companies developing such treatments. GenScript has a proven track record of providing sgRNA and non-viral DNA payloads at cGMP quality, along with complete batch records, documentation and regulatory support required for gene and cell therapy development and successful IND filing.

GenScript's ongoing commitment to meeting the needs of research scientists

In 2020, GenScript established a 21,500-square-meter cGMP facility 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 biopharmaceutical and pharmaceutical companies globally in the gene and cell therapy space and has supported 18 project applications, five of which have received IND approval. This latest expansion brings an additional 400,000 square meters of cGMP production space to Zhenjiang, commissioning four additional production lines equipped to provide superior purity, gram quantities of sgRNA or hundreds of milligrams of ssDNA or dsDNA per batch, respectively. Ray Chen, head of the Life Sciences Group at GenScript, said: "GenScript is pleased to have completed the expansion of our cGMP sgRNA and non-viral DNA payload production capacity for IND filing and clinical trials. In recent years, in response to the increasing demand we have seen globally, GenScript has made significant investments in a broad array of reagent services, enabling our customers to advance their gene and cell therapy pipelines. The opening of our newest cGMP production facility represents our strong commitment to supporting our gene and cell therapy customers." Luc Ruelens, GMP project lead at GenScript, stated: "The new Zhenjiang state-of-the-art cGMP facility has been designed and qualified to meet GMP requirements of major regulatory agencies such as the FDA, EMA, PMDA and NMPA. GenScript has established a stage-appropriate cGMP system, including a materials system. The facility and equipment system, laboratory control system, production system and packaging and labeling system are all integrated into the quality system," he added. "The final aseptic fill step in production is performed in a specialized Class A isolator. The facility, sterile filtration and aseptic operations have been validated in accordance with regulatory guidelines and industry standards." Source