Proliferation of primary human fibroblasts and keratinocytes
The next step in the production process is the cultivation of the extracted primary keratinocytes and fibroblasts in closed cell culture flasks. A newly developed, highly flexible membrane bioreactor in standard MTP format facilitates droplet seeding, steady media flow, online proliferation density and contamination measurements as well as enzyme-free cell detachment. With a capacity of 500 flasks / bioreactors, the cells are treated according to a cultivation protocol that was specifically adapted for the fully automated process. The effect of the inherent donor dependency of the batches on cell proliferation is reduced significantly by the 14-days cultivation protocol. Source material contamination is detected by regular, multi-parametric measurements before and after media changes. In the case of positive result, the concerned flask (batch) is discarded and a fully sterile setup is restored by multi-level cleaning protocols. In consequence, the cell expansion module acts as a filter for batch homogeneity and additional quality assurance with regard to the subsequent tissue build-up.
- Total capacity of 500 cultivation flasks in MTP format
- Monthly throughput of 375 million fibroblasts and 750 million keratinocytes
- Non-invasive cell vitality and contamination measurements as well as multi-level cleaning protocols
- Membrane bioreactor in standard MTP format