Automation is increasingly finding its way into biotechnological laboratory and production environments. It allows throughput and reproducibility to be increased and thus safe products to be manufactured in efficient processes. However, not only the right device is sufficient for automation - the processes also have to be translated and optimized accordingly. That's why we develop automatable protocols even for complex biotechnological processes.
One example of such time-consuming and labour-intensive processes is the proliferation of stem cells. The Fraunhofer IPT offers technical solutions for the automated cultivation of stem cells in order to reduce the effort and reduce errors caused by human interaction with the cells. We draw on experience from past and current projects in which we have developed fully automated systems for the production of induced pluripotent or mesenchymal stem cells for research and therapy. Using intelligent process control and individual measurement technology, the cells are produced in 2D culture or in a bioreactor. Particular attention is paid to compliance with GMP/GAMP recommendations (Good Manufacturing Practice/Good Automated Manufacturing Practice) so that biological processes are carried out in accordance with these guidelines.
The GMP Wiki was developed at the Fraunhofer IPT for the implementation of these guidelines. In this Wiki, the design requirements resulting from the GMP guidelines are considered, so that the development of new designs is carried out in accordance with GMP. In addition, the GMP Wiki is currently being extended to include software, so that the software developed is checked and validated in accordance with the guidelines in Appendix 11 of the GMP Guideline.