Kriya Therapeutics announced today that it has secured a 51,350 square foot operational manufacturing facility in Research Triangle Park (RTP), North Carolina to support the scalable production of its pipeline of AAV-based gene therapies for highly prevalent 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 current good manufacturing practice (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.
Gene Therapy Bottleneck: Manufacturing
“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,” said Shankar Ramaswamy, M.D., 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.”
Gene Therapy Growth
The gene therapy segment of the biopharmaceutical market continues to grow with no end in sight. While some market research firms estimate the gene therapy market to equal about $1.2 billion in 2019, they expect $2.07 billion this year. Moreover, the global gene therapy market is forecast to grow at a fast rate of 16.6% from 2021 to 2027 to total $6.56 billion by 2027, reports Grandview Research.
About Kriya Therapeutics
Kriya Therapeutics is a next-generation gene therapy company focused on developing transformative treatments for highly prevalent serious diseases. With core operations in California and North Carolina, Kriya’s technology-enabled platform is directed to the rational design and clinical translation of gene therapies for large patient populations.
This venture, just launched in 2019 has already raised $80.5 million in its A round. The brainchild of Dr. Shankar Ramaswamy (formerly led Axovant Gene Therapies), Fraser Wright (Sparks Therapeutics) and Roger Jeffs (United Therapeutics), the firm has offices in Palo Alto (Silicon Valley) and Durham (RTP). The company positions itself as the ‘next-generation gene therapy company” targeting development of gene therapies for highly prevalent and severe chronic conditions, such as diabetes and obesity.
Investors include QVT, Dexcel Pharma, Foresite Capital, Bluebird Ventures (associated with Sutter Hill Ventures), Narya Capital, Amplo, Paul Manning and Asia Alpha.