Process Assessment & Development
At Catalent, we execute with a long-term vision for your cell therapy product. Our 5-step in-house approach translates your discoveries into manufacturable treatments at scale. We develop a comprehensive industrialization plan early on, reducing erroneous processes and manual steps, while accounting for parameters such as materials, new processes, testing and costs. This lays the foundation for a successful technology transfer, development, and industrialization. As you evolve with us, our custom methodology allows for a faster transition of your therapeutic to commercial phase.
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
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.