China-based GenScript Biotech Corporation (HKG: 1548) has announced the expansion of its current Good Manufacturing Practice (cGMP) manufacturing capacity at a new facility located in Zhenjiang, Jiangsu province. This move is set to enhance the company’s ability to offer manufacturing services for sgRNA and non-viral DNA payloads, thereby better serving clients in the gene and cell therapy sectors.
Enhancing Manufacturing Capabilities for sgRNA and DNA Payloads
Single guide RNA (sgRNA), also referred to as CRISPR sgRNA, is a crucial component in the CRISPR gene editing process, responsible for recognizing and guiding the Cas9 nuclease to the target DNA region for editing. GenScript has already established a 21,000 sq. ft. manufacturing capability for sgRNA and non-viral DNA payloads at its Nanjing site. The new Zhenjiang facility, at a much larger scale of 400,000 sq. ft., features four additional production lines capable of producing gram quantities of sgRNA or hundreds of milligrams of ssDNA or dsDNA per batch.
Supporting Gene and Cell Therapy Development
In addition to its manufacturing capabilities, GenScript also provides comprehensive services, including full batch records, documentation, and regulatory support necessary for the development of gene and cell therapies and successful Investigational New Drug (IND) filing. This expansion at the Zhenjiang facility will help address the frequent shortages of GMP-standard gene editing materials that can lead to delays in the drug development process, thereby bolstering the company’s position as a key player in the gene and cell therapy manufacturing space.-Fineline Info & Tech