A carefully designed and controlled process development system addresses product safety, efficacy, reproducibility, and manufacturing scale up. A critical review of the manufacturing process and all the materials and reagents involved in the production steps is required to avoid potential product quality and safety issues. PACT cell processing facilities (CPF) are experienced in the development of reproducible, large-scale methodologies, and are well acquainted with equipment and reagent qualification steps, as well as specific testing requirements when clinical grade reagents are not available.
Products approved by the program team for manufacture will be produced by the designated CPF according to the applicable regulatory requirements. The CPF contracted to manufacture the cellular therapeutic product will be determined based on the experience and expertise at the CPF and the production workload at each CPF. The CPF will assist the approved investigator with refining project work plans and timelines for his/her project.