Catalent reported that it has accomplished and opened a brand new commercial-scale cell remedy manufacturing facility at its European heart of excellence for cell therapies, in Gosselies, Belgium. The brand new facility encompasses 60,000 ft2 (5,600 m2) of devoted cell remedy manufacturing house housing multi-product, segregated suites designed to assist autologous and allogeneic cell remedy manufacturing by way of to late-stage medical and commercial-scale provide.
The power, which has been designed to be EMEA and FDA compliant, with Grade B and C suites to assist high-throughput processes and accommodate bioreactor-scale cell remedy manufacturing in addition to on-site high quality management (QC) laboratories and warehousing, is the newest addition to Catalent’s Gosselies campus, which already features a 67,000 ft2 (6,200 m2 ) medical manufacturing facility providing superior medical and business provide options.
The general Gosselies campus gives course of and analytical improvement labs, greater than 20 CGMP grade B and C cleanrooms, devoted QC labs, certified particular person (QP) companies, and warehousing, based on Manja Boerman, Catalent’s president, BioModalities (Cell, Gene, and Protein Therapies).
“Catalent allows totally built-in cell remedy companies—from our iPSC experience in Düsseldorf, Germany, to course of and analytical improvement in Gosselies, to medical and business manufacturing in Gosselies and Princeton, New Jersey—all beneath one CGMP umbrella,” added Boerman. “Along with our built-in plasmid DNA and viral vector companies, the Catalent Cell & Gene Remedy community gives end-to-end companies for improvement, scaleup, and business launch of superior therapies.”
The Gosselies campus additionally contains separate plasmid DNA (pDNA) improvement and manufacturing amenities. The clinical-scale pDNA facility, at 17,000 ft2 (1,600 m2), contains R&D, course of improvement, QC labs, and a number of CGMP manufacturing suites. The commercial-scale pDNA facility, at 32,400 ft2 (3,010 m2), provides large-scale manufacturing.