CRISPR non-viral gene insertion methods have gained popularity among researchers. GenScript, as the leading provider of non-viral HDR template solutions, now offers cGMP GenExact™ single-stranded DNA (ssDNA) and GenWand™ closed-end linear double-stranded DNA (dsDNA) services. These services will enable newer gene and cell therapy R&D programs to advance to IND filing and clinical trials faster and more efficiently.
GenScript’s cGMP manufacturing lines are located in ISO Class 7 cleanrooms, and include ISO Class 5 isolators for aseptic processing operation. The cGMP manufacturing lines operate a Quality Management System that meets the requirements for APIs for use in clinical trials as defined by ICH Q7 Good Manufacturing Practice for Active Pharmaceutical Ingredients, Section 19.
Non-viral Payload Leader
Innovator and leader in providing long and complex ssDNA and dsDNA HDR templates
Comprehensive documentation supporting the IND filing process
Enabling Faster Cell Therapy R&D
Non-viral HDR templates in combination with CRISPR technology accelerates cell engineering compared to traditional viral-based engineering.
Early Discovery to Clinical Trials
Different grades of non-viral HDR materials that support your research from early discovery to process development to clinical studies
Quality, quantity, and product specifications according to your needs
Optimized production process to deliver high quality materials
Material management and supplier management in compliance with cGMP regulations
Phase appropriate cGMP deployment based on stage of clinical trial and process understanding
Basic Quality Management Systems in place (Training, Deviations, CAPA,...)
Manufacturing Summary Report, TSE/BSE Statement
Batch Records based on Master Batch Record and Change Control system