Carsgen Therapeutics’ new facility in North Carolina is poised to begin making candidate CAR-T cell therapies for trials after passed an inspection.

The facility in Research Triangle Park (RTP) – which official opened this week – was issued with a certificate of compliance after being visited from inspectors from Durham city council.

Company president Richard Daly welcomed the decision as an important expansion of Carsgen’s manufacturing network.

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“RTP manufacturing facility plus two Carsgen existing GMP facilities in Shanghai, China will enhance our global manufacturing capacity, strengthen supply chain sustainability, advance our clinical studies, and position Carsgen for early commercial launch.”

The facility, which has a total floor area of approximately 3,300 square metre, is kitted out for the production of autologous CAR T-cell products for 700 patients annually according to Carsgen.

The plan is to support the company’s clinical studies and early commercial launch in North America and Europe.

Construction of the project received the Job Development Investment Grant (JDIG) award and other investment incentives from North Carolina State officials, Durham County and Durham City.

Carsgen said it is building a world-class chemistry manufacturing and controls (CMC) team for the RTP manufacturing facility operations.

Pipeline

The facility opening comes weeks after the US Food and Drug Administration (FDA) CTO41 – Carsgen’s autologous cell therapy for adenocarcinoma of the stomach, gastroesophageal junction and pancreas – regenerative medicine advanced therapy (RMAT) designation.

The status means CT041 enjoys all the benefits of Fast Track and Breakthrough Therapy designations including early and intensive FDA guidance on efficient product candidate development and eligibility for rolling review and priority review.

And – according to Carsgen – products granted RMAT designation may also be eligible for accelerated approval.

The product was also granted Priority Medicines (PRIME) eligibility by the EMA last November.