Krystal moves towards ‘full integration’ with gene therapy facility opening

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/Adriano_cz)
(Image: Getty/Adriano_cz)

Related tags: Krystal Biotech, Gene therapy

Krystal opens cGMP facility for the clinical and commercial manufacture of its lead drug candidate, KB103, and plans to open its second in 2020.

After an opening ceremony for its Pennsylvania, US, facility, Krystal Biotech stated that it would build a second facility to become a fully-integrated gene therapy company.

The opening ceremony was preceded by a successful trial run of the manufacturing capabilities of the 4,500ft2​ site.

“Completing a successful trial run is another step towards our goal of becoming a fully integrated gene therapy company and continue to fulfil our commitment to fundamentally treating rare skin diseases in a painless, convenient and effective manner," ​said Suma Krishnan, founder and COO of Krystal.

While its second facility opening is in the works, Krystal’s newly opened current good manufacturing practice (cGMP), Pittsburgh site will handle the clinical and commercial manufacture of its lead product, KB103.

The drug candidate is a potential off-the-shelf, topical gene therapy for dystrophic epidermolysis bullosa, an incurable skin blistering condition caused by a lack of collagen protein in the skin.

Previously, CEO, Krish Krishnan, explained that KB103 would be delivered as a reverse thermal gel​, which is a liquid in frozen conditions and then solidifies at room temperature to be used topically – potentially allowing it to be administered by the patient themselves, at later stages of development.

According to the company, the next step towards full integration will be to create an additional, larger facility in Pittsburgh. The second site is expected to be completed by 2020 and will allow the biotech to meet future research, clinical and commercial demand for its pipeline of products.

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