Krystal Biotech Builds New Commercial Manufacturing Facility for Gene Therapy
“Having our own GMP facility will allow us to keep important proprietary process development and associated intellectual property in-house,” says Suma Krishnan, founder and chief operating officer of Krystal.
PITTSBURGH, PA—Krystal Biotech, a gene therapy company developing treatments for rare dermatological diseases, has completed construction of Ancoris, a new state-of-the-art Good Manufacturing Practice facility near the company’s headquarters in Pittsburgh.
The new facility will support clinical and commercial manufacturing of Krystal’s lead product candidate, KB103, for the treatment of dystrophic epidermolysis bullosa, a genetic skin disorder that causes skin to tear or blister from minor contact. 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,” says 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. A second phase of the manufacturing strategy has begun 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 allow us to keep important proprietary process development and associated intellectual property in-house,” says 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.”