- 51,350 square foot operational manufacturing facility based in Research Triangle Park, North Carolina is designed to have its own fully integrated process development lab, pilot production suite, and current good manufacturing practice (cGMP) production capability
- The facility will use Kriya’s scalable suspension cell culture manufacturing process to produce material at 50-liter up to 2,000-liter bioreactor scale
- Pilot production is expected to be online in the first half of 2021, with full cGMP production expected to be online in the second half of 2021 to support the production of clinical-grade material for Kriya’s pipeline programs
Palo Alto, California and Research Triangle Park, North Carolina – August 4, 2020 – 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.
“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.”
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. For more information, please visit www.kriyatx.com.
Cautionary Note on Forward-Looking Statements
This press release includes forward-looking statements pertaining to the usage and capabilities of our manufacturing facility, our costs, and the potential of our platform. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. The forward-looking statements contained in this press release reflect Kriya’s current views with respect to future events, and Kriya does not undertake and specifically disclaims any obligation to update any forward-looking statements.
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Original Article Source: Kriya Therapeutics