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CGMP Manufacturing

Our CGMP manufacturing services deliver excellence in quality, operations, customer satisfaction, and future vision for 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 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 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 CAR-T being a strategic focus area for cell therapy, we have successfully completed over 8 CAR-T/TCR projects. We are currently developing a cutting-edge fill & finish platform to overcome major challenges associated with scalability of allogeneic therapies.

We are continuously innovating for efficiency and accelerated clinical path.  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 partner for the end-to-end production of advanced therapeutics.