Krystal Biotech announced construction of Ancoris, a new state-of-the-art Good Manufacturing Practice (GMP) facility, is complete. The new facility is located near the Company’s headquarters in Pittsburgh and will support clinical and commercial manufacturing of Krystal’s lead product candidate, KB103, for the treatment of dystrophic epidermolysis bullosa (DEB). The facility will be officially open in 1Q 2019 following completion of the first engineering run.

"Our development of internal manufacturing capabilities bolsters our position for commercial readiness as we execute on our vision to bring our therapies to the patient communities in need," said Krish S Krishnan, chairman and chief executive officer of Krystal Biotech. "We thank the City of Pittsburgh and the Mayor’s office for helping us complete construction in a timely manner and we intend to have a formal inauguration following completion of a trial run in 1Q 2019."

The 4,500 square foot facility has been designed to satisfy the necessary manufacturing requirements for commercial development of KB103 and the highest current GMP standards governing commercial production for biopharmaceutical use. The Ancoris facility will be the primary production site to meet projected commercial demand for KB103. In addition, a second phase of the manufacturing strategy has been initiated with plans to build a second, larger GMP manufacturing facility in Pittsburgh that will support the anticipated commercial demand for future developmental pipeline programs. The second facility is anticipated to be complete in 2020.

"Having our own GMP facility will enable our STAR-D HSV-1 based platform to be fully integrated and allow us to keep important proprietary process development and associated intellectual property in-house," said Suma Krishnan, founder and chief operating officer of Krystal. "Ancoris and the second GMP facility we have planned will ensure that we are able to meet the manufacturing demands of all our research and potential commercial programs."

KB103 is Krystal’s lead product candidate that seeks to use gene therapy to treat dystrophic epidermolysis bullosa, or DEB, an incurable skin blistering condition caused by a lack of collagen in the skin. KB103 is a replication-defective, non-integrating viral vector that has been engineered employing Krystal’s STAR-D platform to deliver functional human COL7A1 genes directly to the patients’ dividing and non-dividing skin cells. HSV-1 is Krystal’s replication-deficient, non-integrating viral vector that can penetrate skin cells more efficiently than other viral vectors. Its high payload capacity allows it to accommodate large or multiple genes and its low immunogenicity makes it a suitable choice for direct and repeat delivery to the skin. Recent interim Phase 1/2 trial results showed fast and durable wound closure in two adult DEB patients as well as a promising safety profile.

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