Krystal expands commercial gene therapy production

January 28, 2020 -- Krystal Biotech on January 24 announced the beginning of construction on its second commercial gene therapy facility in Findlay Township in Pennsylvania. The facility will have the capacity to produce commercial gene therapy medicines for a variety of rare diseases.

The Current Good Manufacturing Practice (cGMP) facility, named ASTRA, expands on Krystal's current production capabilities, with in-house incorporation of raw material preparation, excipient manufacturing, testing, packaging, labeling, and distribution. ASTRA will fully integrate all components in the supply chain from starting materials to patient experience.

Over the next 12 to 15 months, validation throughout the 100,000-sq-ft space will occur. The state-of-the-art facility will initially be used as a commercial backup facility for bercolagene telserpavec (B-VEC), a gene therapy for treatment for dystrophic epidermolysis bullosa.

After the initial phase, Krystal plans to expand the use of the facility to produce investigational and commercial materials for its pipeline products. Upon opening, the facility will create 75 to 200 new jobs in biologics manufacturing.

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