Kriya Ther­a­peu­tics Announces the Estab­lish­ment of its Internal Man­u­fac­tur­ing Facility for Process Development and Scalable cGMP Production of Gene Therapies for Prevalent Serious Diseases

  • 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.

Contact
Daniel Chen
Chief Financial Officer
dchen@​kriyatx.​com