Synthego, the genome engineering company, today announced it has adopted Good Manufacturing Practice (GMP) standards to provide academic and industry partners with high-quality reagents for use in clinical research and development (R&D).
Synthego's state-of-the-art facility will produce customized GMP-grade synthetic guide RNA (sgRNA) used for gene-editing, extending the company's ability to support the full spectrum of R&D in the next generation of cell and gene therapies.
The company's GMP adoption for gene engineering addresses the biopharmaceutical industry's unmet need for timely, effective, and cost-efficient clinical R&D tools to improve treatments for thousands of genetic disorders.
"Flexibility, customer support, and rapid turnaround time are key reasons why PACT Pharma selected Synthego," said Kyle Jacoby, Gene Editing associate director, PACT Pharma, Inc.
Developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), GMP is a system of quality guidelines for ensuring that pharmaceutical products are consistently produced and controlled. Synthego's GMP-grade sgRNA is available starting the first quarter of 2020 in multi-gram quantities, adhering to the highest quality of material purity, manufacturing consistency, and quality control while meeting quick turn-around customer requirements. Synthego's GMP-grade sgRNA encodes target sequences designed by industry and academic partners to support specific scientific research efforts.
"With thousands of known genetic disorders impacting millions of people and no available treatments for them, it is critical for our industry to safely develop a new generation of accessible therapies," said Paul Dabrowski, CEO and co-founder of Synthego. "Offering GMP products for use in genome editing brings us one step closer to our mission of making agile, precision R&D accessible to therapeutic developers. We are proud to collaborate with industry and academic institutions as they bring innovative treatments from the lab to clinical trials."
Rooted in engineering principles, Synthego's multidisciplinary integration approach is at the forefront of synthetic biology innovation and provides partners in academia and industry with unprecedented access to high-quality genome engineering products from screening and target validation to clinical development, with applications across multiple disease areas.
For more detail, visit: www.synthego.com