Process Development
The Science of Innovation
To pilot your cell therapy innovation towards clinical trials and successful commercialization, it is imperative to incorporate robust process development. This entails establishing a reproducible and efficient production methodology capable of accommodating scalability, whether it be scaling up for allogeneic applications or scaling out for autologous scenarios.
Our ultimate goal is economic viability throughout the development and commercialization phases. We swiftly adapt and refine techniques in real time, shortening the transition from research to production. It’s all structured on a foundation of scientific rigor, standard operating procedures, clear communication paths, comprehensive accountability, and documented decision-making.
Process development aims to gain efficiency and drive down costs while maintaining or improving quality. It applies to all process elements (upstream and downstream) including cell isolation, cell expansion, characterization, optimization of cell culture media, scale-out, scale-up, removal of impurities, final formulation and fill finish activities.
Source: Stem Cells Transl Med. 2015 Oct;4(10):1155-63