Establishment of new method for massproduction of novel cancer vaccine.

Purpose and goal

Immunciums established manufacturing concept allows therapeutic, immune-based and personalized cancer vaccine to be produced on material from allogeneic donors. The process is robust and has delivered material to two clinical development programs in metastatic renal cell carcinoma and primary liver cancer. In the current project, the company along with Cancer Center Karolinska evaluated alternatives for continued industrial adaptation of the production process.

Results and expected effects

The project has shown that the manufacturing concept provides opportunities for change in early processing steps with continued production of high-quality vaccines. The project has analyzed current and future development potential of the process and quality control. This analysis has also been implemented at the organizational basis for cost-effective management. The project has demonstrated the concept´s good production economy and set boundary conditions for the production associated with different developmental stages.

Approach and implementation

The project was conducted in conjunction with Cancer Center Karolinska. Involvement of process consultants, specializing in cell therapy, has given opportunities to take a broader grasp of the process and the industrial integration of this. In this process, CCKs experiences of the process played an important role, which is a precondition for further work. Because of limited time and early analysis has a number of technical parameters, believed to be of lower priority, not been evaluated by the project. These are intended to be analyzed in future work together.