Kriya Therapeutics has set up a facility in North Carolina to support the production of its pipeline of AAV-based gene therapies.
The site at Research Triangle Park (RTP) will house a process development lab, quality control and analytical development capability, pilot production suite.
In addition, the facility will also have a current good manufacturing practice (cGMP) standard production infrastructure for gene therapies.
CEO Shankar Ramaswamy told Bioprocess Insider: “By establishing our own internal manufacturing facility, we can help ensure that we have the requisite capacity to support our pipeline of programs aimed at addressing large patient populations.
“Moreover, we can make the necessary investments in process development and scale to further refine our own proprietary manufacturing methods – with a goal of achieving profound reductions in the cost of goods of our therapies.”
He added, “Our ability to accomplish the above is uniquely enabled by having our own internal manufacturing capacity rather than outsourcing the work to a third party.
Kriya will make gene therapies at the facility using a suspension cell culture manufacturing process at up to 2,000-liter bioreactor scale.
The pilot plant and the manufacturing suite are expected to be operational next year.
The firm’s pipeline of AAV-delivered gene therapies includes three products designed to treat various forms of diabetes and associated conditions.
KT-A112 encodes insulin and Glucokinase and is intended as a therapy for type 1 and type 2 diabetes Mellitus. KT-A832 which encodes insulin growth factor 1 and is intended for patients with type 1 diabetes Mellitus.
Kriya licensed both programs from researchers at the Universitat Autònoma de Barcelona, Spain (details here in Spanish).
The firm’s third pipeline candidate – KT-A522 – encodes glucagon like peptide which is in development for type 2 diabetes Mellitus and obesity.
The third program was licensed from the US National Institutes of Health.
Kriya was founded last year by execs from several gene therapy firms, including Spark Therapeutics, AveXis, and Sangamo Therapeutics.
News of the facility comes just months after Kriya secured $80 million in a series A funding round.
According to Crunchbase the firm attracted backers including QVT, Dexcel Pharma, Foresite Capital, Bluebird Ventures, Narya Capital, Amplo, Paul Manning, and Asia Alpha.
Kriya says its aim is to target conditions “where the underlying biology is well-understood, rationally designing one-time gene therapies to durably express therapeutic proteins within the appropriate human tissues.”