Process Diagnosis & Development
At Catalent, we execute with a long-term vision for your cell therapy product. Our experts are focused on developing a commercial-ready process early in your project to allow for efficient transition to the late-stage manufacturing and decreased time to the clinic. We utilize our in-house process diagnostic tool that lays the foundation for a successful technology transfer, development, and industrialization. We also employ a fully integrated team between the development and manufacturing phase, for a seamless transition of your cell therapy product, therefore, saving costs, resources, and time to market. We combine our CGMP expertise, our scientific and manufacturing know-how to address specialized needs of your cell type and your project.
We approach the process development plan with an integrated analytical strategy while considering key assessment factors for both phases.
- Scale-up or scale-out
- Costs and risk reduction
- Implementation of industrial equipment to automate the process
- Closing the open-phase stages
- Rationalization of sampling plan
- Development of analytical methods
- Process and product characterization (potency assay) validation
- Product comparability throughout development
Our forward-looking methodology has been crucial in building a longterm collaboration with our partners and advance their cell therapy products from the bench to the clinic.