Krystal Biotech Opens Gene-Therapy Manufacturing Facility

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