Krystal Biotech announced that construction of Ancoris, a new good manufacturing practice, or 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, or DEB. The facility will be officially open in Q1 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.
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