Krystal Biotech, Inc., a gene therapy company developing medicines to treat rare diseases, broke ground on its second commercial gene therapy facility in Findlay Township, Pennsylvania.
The 100,000 square foot facility will be built-out and validated over the next 12 -15 months, company officials said. Opening the ASTRA facility will create about 75 new jobs in western Pennsylvania, with the potential to create upwards of 200 new jobs when at full capacity.
The Findlay-based Current Good Manufacturing Practice facility, named ASTRA, will have the capacity to produce commercial gene therapy medicines to treat patients suffering from debilitating rare diseases.
"Biologics manufacturing is a complex science and is a competitive advantage for Krystal Biotech," said Krish S. Krishnan, chairman and CEO at Krystal. “We are very excited to announce the creation of ASTRA which will be a global resource for production of gene therapies with the potential to bring new treatments to rare disease patients around the world. The success with our first GMP facility, Ancoris, gives us the experience and confidence to have ASTRA be functionally ready in time for the anticipated launch of our lead therapeutic, B-VEC (previously KB103)."
According to company officials, the ASTRA facility is being designed as a state-of-the-art cGMP manufacturing facility that, beyond expanding Krystal's current production platform, will allow the in-house incorporation of raw material preparation, excipient manufacturing, testing, packaging, labeling and distribution, fully-integrating all components of the supply chain from starting materials to patient experience.
The ASTRA facility will initially be used as a commercial back up facility for B-VEC, which is being developed for the treatment of dystrophic epidermolysis bullosa, a rare and devastating skin disorder, and expand to produce investigational and commercial material for our pipeline products.
Mark Thomas, president of the Pittsburgh Regional Alliance, added, “It’s a signal of confidence in a region’s economy when businesses elect to expand where they first established. We congratulate Krystal Biotech on the success it has achieved in the Pittsburgh region since 2016 and its latest plans for expansion, the largest biotech investment in the region to date. We recognize that companies in the life sciences sector have no shortage of locations to consider when it comes to growth and expansion. Krystal Biotech’s commitment to Pittsburgh reinforces the comprehensive efforts in motion in the region to ensure that companies committed to solving the world’s biggest challenges, saving lives and advancing wellness find the talent, space and community of support in Pittsburgh that enable thriving and growing.”
Christopher Molineaux, president of Life Sciences Pennsylvania, commented, “We are delighted to see Krystal Biotech expand their headquarters in Pittsburgh. Pennsylvania is home to more than 2,800 life sciences establishments and Krystal Biotech has become a beacon of transformational science in that community that will ultimately serve patients around the world.”