The manufacture of ATMP – innovative cell-based therapies, such as tissue engineering products, somatic cell therapies and adult stem cells – has the potential to revolutionize the treatment of a number of medical disorders. However, due to varying requirements and relevant practices compliant with GMP, these call for different manufacturing concepts other than those used for automated cell cultivation in the research field. We research and develop new automation strategies and solutions for manufacturing personalized advanced therapy medicinal products.
Although cell-handling technologies have not changed, their method of implementation in ATM product manufacture has to be adapted in order to comply with GMP requirements.
The new manufacturing technologies developed by us aim to:
In order to do away with large complex cleanroom systems, one of the key technologies influencing future manufacturing processes for advanced therapy medicinal products is “integration into the sample”. By constructing individual process modules, scale-out strategies can be implemented. These allow personalized (autologous) cell therapy production at high throughput rates with assured batch separation.