Kriya Therapeutics secured a 51,350 square foot operational manufacturing facility in Research Triangle Park (RTP), NC to support the scalable production of its pipeline of AAV-based gene therapies for serious diseases. The facility is designed to have its own fully integrated process development lab, quality control and analytical development capability, pilot production suite, and cGMP production infrastructure.
Kriya will manufacture gene therapies at the facility using its scalable suspension cell culture manufacturing process at up to 2,000-liter bioreactor scale. The facility’s pilot production suite and full cGMP manufacturing infrastructure are expected to be online in the first and second half of 2021, respectively.
“Manufacturing continues to be a critical bottleneck to the advancement of gene therapies for prevalent diseases,” said Britt Petty, chief manufacturing officer at Kriya Therapeutics. “With the establishment of our cGMP manufacturing facility in North Carolina, we are preparing to have the capacity to support our pipeline of programs addressing large patient populations, from initial INDs through late-phase clinical studies. Moreover, we are investing in process innovation and scalable infrastructure with the goal of reducing the cost of goods of our therapies by orders of magnitude.”
“As we develop our platform technologies and advance our pipeline of gene therapies, we are committed to securing the capacity to support the manufacturing of our products at scale,” added Shankar Ramaswamy, MD, co-founder, chairman, and CEO of Kriya Therapeutics. “Our investment in our RTP facility helps establish this capability in a region with tremendous talent in gene therapy manufacturing, while also enabling our team to focus on innovations to bring down the cost of goods of our gene therapies.”