Krystal Biotech Inc. Completes Construction of Ancoris
January 15, 2019 at 01:00 pm
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Krystal Biotech Inc. announced that construction of Ancoris, a new 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 First Quarter 2019 following completion of the first engineering run. 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.
Krystal Biotech, Inc. is an integrated, commercial-stage biotechnology company. It is focused on the discovery, development, and commercialization of genetic medicines to treat diseases with high unmet medical needs. Its product candidates in various stages of clinical and preclinical development include VYJUVEK, KB407, KB408, KB707, KB105, KB104, KB104, and KB301. Its commercial product VYJUVEK is a non-invasive, topical, redo sable gene therapy designed to deliver two copies of theCOL7A1 gene when applied directly to DEB wounds. VYJUVEK is designed to treat DEB at the molecular level by providing the patientâs skin cells the template to make normal COL7 protein, thereby addressing the fundamental disease-causing mechanism. KB407 is developed for the treatment of Cystic Fibrosis. KB408 is developed for the treatment of Alpha-1 Antitrypsin Deficiency. KB707 is developed for the treatment of solid tumors. KB105 is developed for TGM1-Deficient Autosomal Recessive Congenital Ichthyosis.