Process Development

The following parameters are crucial to the proper emulation of primary human tissues in vitro, but are currently underestimated in bioreactor and tissue culture developments:

• the constancy of the systemic pH, pCO2, pO2;

• the physiological nature and effective range ofthe buffer systems (e.g., carbonate, hemoglobin, etc.); and

• the consistency and composition ofinterstitial fluids (redox potential, osmolality, growth factors, lipids, proteins, etc.).

The reasons for this are either limited knowledge of their importance in human organ and system behavior, or an insufficiency of currently available technical solutions to maintain these parameters within a specific range of action. Such parameters must be designed for the in-vitro needs of each and every relevant human micro-organoid, which is thought to be in accordance with their original environment (which might differ dramatically between sub-organoids in the liver, kidney or brain). Nonetheless, generalized ranges of acceptance parameters for the supply of nutrients and the removal of waste products can be drawn up for human tissues. Moreover, the individual layout for each envisioned micro-organoid can differ substantially, and this will impact on both the bioreactor design and process development.

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