Currently, manual fill/finish processes and handling of cells during these activities have served as a major deterrent for scalability of cell therapies. From manual filling to visual inspection of each bag or vial to maintaining optimum temperature and storage conditions of the cells, each step of fill/finish is accompanied by its own challenges for manufacturers. Despite these bottlenecks, the Cell Therapy team at Catalent has customized the fill/finish services to the specificity of the cell therapy products. Additionally, the team is embarking on a continuous innovation to move therapies to commercial readiness state.
For autologous products, our team gives careful consideration to a multi-step supply chain process to ensure the highest quality standards. From performing bag filling under strictly regulated aseptic conditions to careful visual inspection of each bag post-fill, our team manages each detail of these critical steps with accuracy. The bags are then frozen under temperature-controlled conditions maintained by a control rate freezer. These frozen bags are transferred into vapor phase nitrogen freezers offering a long-term storage option for these therapies.
For allogenic products, our team has adopted a robust fill/finish platform to address the capacity challenges tied to scaling-up cell products. A closed-vial system developed by Aseptic Technologies has been implemented to ensure container integrity at a storage temperature of below -150°C. Filling is performed using the Crystal® M1 station under a class A laminar flow in a class B room. The equipment is validated to perform 1mL and 5mL closed vial filling. An upgraded version of this filling platform is being implemented in early 2021 with the potential to add additional filling capacity using the Crystal® Pure M1 isolator system. This increase in efficiency will allow our team to more effectively scale-up allogeneic cell therapies to commercial manufacturing capacity.