The state-of-the-art facility contains development and manufacturing space across multiple cleanrooms for the dedicated production of CGMP-grade pDNA for clinical and commercial-phase supply

The new Case Management Service addresses challenges associated with delivering advanced therapies to patients by providing supply chain oversight from program start to finish.

Mr. Zayas will be responsible for Catalent’s North American biologics operations. He will serve on the Executive Leadership Team, reporting directly to President & CEO, Alessandro Maselli.

Catalent and Ethicann announced a development and license agreement to develop Ethicann’s clinical drug pipeline using Catalent’s proprietary Zydis® orally disintegrating tablet technology.

Catalent and Sarepta sign an agreement to manufacture delandistrogene moxeparvovec, Sarepta’s most advanced gene therapy candidate for the treatment of Duchenne muscular dystrophy.

Catalent today announced a $12 million expansion program to increase biologics CGMP analytical capabilities at its flagship facility in Kansas City, Missouri.

The new facility will be one of the largest in the world with multi-product, segregated suites designed to support autologous and allogeneic cell therapy manufacturing.

The project has seen the site increase by approximately 30,000 square feet, which has allowed the installation of additional refrigerated and deep-frozen storage, and secondary packaging capabilities to be expanded.

The ADC candidates have been developed using Catalent’s proprietary SMARTag® technology.