Cell Expansion Module

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.


Specifications

  • 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