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The new facility, located at the company’s headquarters in Pittsburgh, PA, is expected to meet all clinical and commercial development needs of the company’s lead gene therapy program.
On March 6, 2019, Krystal Biotech, a gene-therapy company specializing in dermatological diseases, officially opened Ancoris, a new cGMP facility at its headquarters in Pittsburgh, PA, for clinical and commercial manufacture of its lead product, KB103. A second, larger cGMP facility expected to be completed in 2020 to meet all anticipated future pipeline production requirements.
The new 4500-ft2 facility is designed to satisfy the necessary manufacturing requirements for clinical and commercial development of KB103, an “off-the-shelf” therapy being developed for people with dystrophic epidermolysis bullosa (DEB). KB103 is currently in a Phase II clinical study and data are expected in mid-2019.
In addition to the current cGMP facility, Krystal plans to initiate the second phase of its manufacturing strategy with plans to build a second, larger facility in Pittsburgh that will meet all anticipated future research, clinical, and commercial demand for future developmental pipeline products.
"Completing a successful trial run is another step towards our goal of becoming a fully-integrated gene therapy company and continue to fulfill our commitment to fundamentally treating rare skin diseases in a painless, convenient, and effective manner," said Suma M. Krishnan, founder and COO of Krystal, in a company press release. "This facility will be integral for our KB103 program, which we hope to rapidly progress through clinical testing as potentially the first-ever topically applied gene therapy for people suffering from DEB."
Source: Krystal Biotech