Krystal Biotech broke ground on its second commercial gene therapy facility in Findlay Township, Pennsylvania, named ASTRA. The facility will have the capacity to produce commercial gene therapy medicines to treat patients suffering from debilitating rare diseases, according to the company.
“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).”
The ASTRA facility is being designed as a 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 delivery. The ASTRA facility will initially be used as a commercial backup 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. The 100,000 square foot facility will be built-out and validated over the next 12–15 months. 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, according to Krishnan.