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Cell Therapy CGMP Manufacturing

Our CGMP manufacturing services deliver excellence in quality, operations, and customer satisfaction, enabling you to achieve the full potential of your therapeutic product. Catalent has the leading expertise and a global network to scale-up and scale-out allogeneic and autologous therapies, respectively. Our state-of-the-art CGMP facilities in Belgium and the USA are both FDA and EMA compliant, offering flexibility and confidence in manufacturing at a global scale. Our Gosselies, Belgium campus is home to one of the world’s largest commercial-scale cell therapy manufacturing facilities with more than 130,000 square feet of dedicated cell therapy manufacturing and supply footprint, including more than 20 CGMP grade B and C cleanrooms, dedicated QC labs, qualified person (QP) services, and warehousing.

Our expert development and manufacturing teams are fully integrated, including a partnership with our gene therapy teams for viral vector production, allowing the seamless transition of your cell therapy product from development to industrialization. Each facility is equipped with development, clinical and commercial cell therapy manufacturing operations offering full-service capabilities for our client needs.

At Catalent, we have excelled in diverse projects and have a superior track record in both suspension and adherent cells, with 500+ cell therapy batches manufactured to date across autologous and allogeneic cell therapies. With CAR-T being a strategic focus area for cell therapy, we have successfully completed over 10 CAR-T/TCR projects, and we have expertise in a variety of other cell types, including NK, iPSC, MSC, HSC, and TILs, among others. We are currently developing a cutting-edge fill & finish platform to overcome major challenges associated with the scalability of allogeneic therapies.

We are continuously innovating for efficiency and accelerating the path to clinic. Our robust supply-chain management allows us to secure the critical manufacturing materials that will aid in de-risking your therapeutics. Backed by years of success and an industry-leading team of scientists, Catalent is your CDMO partner for the end-to-end production of advanced therapeutics.