GenScript Production Capacity Expanded
GenScript Doubles cGMP sgRNA and Non-Viral DNA Payload Manufacturing Capacity.
With the construction of a brand-new, cutting-edge facility in Zhenjiang, Jiangsu, China, GenScript Biotech Corporation, the foremost supplier of life-science research tools and services, has increased its cGMP manufacturing capacity for sgRNA and non-viral
DNA payloads.
With this most recent expansion, biopharma companies and early-stage startups researching gene and cell therapies now have a quick source for the high-quality components they need to move novel therapies more quickly from the lab to the clinic and onto the market.
"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 leading supplier with the capacity to reduce the lengthy wait times for essential genetic material used to advance life-saving gene and cell therapies — and to lower the significant financial risk assumed by the companies that develop such therapies.
GenScript has a track record of providing non-viral DNA payloads and sgRNA of cGMP quality, complete batch records, documentation, and the regulatory support required for the development of gene- and cell-therapy products and successful IND filing.
GenScript's ongoing commitment to meet the needs of research scientists
A 21,500 square foot cGMP facility with five cGMP production lines for synthetic CRISPR sgRNA and non-viral DNA payloads was established by GenScript in Nanjing in 2020.
To support 18 project applications, five of which have received IND approvals, GenScript has delivered 56 batches of cGMP quality gene editing products to international biotechnology and pharmaceutical companies in the field of gene and cell therapy as of April 2023.
In Zhenjiang, this recent expansion 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 superior-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 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.
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