Synthego, the genome engineering company, announced today that the company has broken ground on a 20,000-square-foot manufacturing facility designed to accelerate translational and clinical research development timelines for cell and gene therapies to as little as a year. The next-generation good manufacturing practices (GMP) factory, an expansion of the Halo™ Platform, will enable Synthego to significantly expand production of its precision gene editing tools which support a broad panel of nucleases, and meet the needs of biopharma customers who are advancing the research and development of CRISPR-mediated gene therapies. The new facility is expected to become operational in late 2022, with a significant amount of capacity pre-allocated and prioritized for development partners.
“We have a clear vision to make engineered biological therapies accessible to all patients, and an important step on this journey is to ensure that we lead the way with innovations that accelerate the path to the clinic for new therapies,” said Paul Dabrowski, Chief Executive Officer of Synthego. “We designed this facility to deliver our GMP single guide RNA (sgRNA) at scale not only to meet the needs of our biopharma partners, but to drive the industry forward and realize the full potential of the rapidly expanding field of cell and gene therapies.”
The 20,000-square-foot facility houses 10,000 square feet of lab space, including dedicated quality control and research and development labs, 7,000 square feet of cleanroom space for 24/7 parallel batch production and full redundancy of infrastructure systems allowing partners to quickly scale from early-phase research to process development to clinical research and development activities needed for FDA submissions. The factory adds to the company’s growing presence in the San Francisco Bay Area.
Synthego was founded to revolutionize genome engineering technology, helping translate genomics into the clinic and ultimately making engineered biological therapies accessible to all patients. The company leverages machine learning, automation, and gene editing to build platforms for science at scale. With its foundations in engineering disciplines, the company’s platforms vertically integrate proprietary hardware, software, bioinformatics, chemistries, and molecular biology to advance both basic research and therapeutic development programs. With its technologies cited in more than a thousand peer-reviewed publications and utilized by thousands of commercial and academic researchers and therapeutic drug developers, Synthego is at the forefront of innovation enabling the next generation of medicines by delivering genome editing at an unprecedented scale. For more information, visit www.synthego.com.