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T-knife and Catalent sign tech transfer and manufacturing agreement

21 Sep 2020

Catalent to manufacture clinical batches of T-knife's platform process for TCR-based cell therapy at its site in Gosselies, Belgium, for European trials in 2021.

T-knife GmbH, a next-generation adoptive T-cell company using its proprietary humanized T-cell receptor (HuTCR) mouse platform to treat solid tumors, and Catalent have signed an agreement to provide technology transfer and cGMP clinical manufacturing of T-knife’s T1367 T-cell receptor (TCR) program.

T1367, which specifically targets MAGE-A1 positive tumors in cancer patients, is expected to be manufactured for clinical trials in both the European Union and the US.

Catalent will undertake transfer of T-knife's platform process for TCR-based cell therapy at its site in Gosselies, Belgium, with the goal of manufacturing clinical batches for European trials in 2021.

T-knife will also prepare for the transfer of the TCR manufacturing platform to Catalent’s Houston, Texas, facility with a view to initiating clinical trials in North America in the future.

“The product candidates based on our proprietary HuTCR platform require sophisticated, state-of-the-art manufacturing capabilities and deep cell and gene therapy know-how,” said Michael Buchholz, Director Manufacturing of T-knife.

“Emerging and innovative treatments such as T1367 are moving rapidly to the clinic,” noted Manja Boerman, President, Cell & Gene Therapy, Catalent. “Catalent is well-suited to support T-knife with focused technology transfer and process industrialization in both Gosselies and Houston.”

Catalent’s 2,400 m2 (25,830 sq. ft) facility in Gosselies, Belgium, provides clinical through commercial-scale cell therapy manufacturing, for both autologous and allogeneic cell therapy treatments.

The facility accommodates four process development laboratories, nine flexible manufacturing clean rooms for cGMP manufacturing, as well as fill and finish services and quality control laboratories.

An additional large-scale commercial manufacturing plant is currently under construction at the site and expected to be fully commissioned in 2021. The company also has a clinical manufacturing site in Houston, which is under qualification and expected to be fully commissioned in 2020.

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