Pharmaceutical Protein
Biotechnological processes can be characterized as processes employing genetically modified microorganisms. These are able to produce biological products which they would never have created in their natural form. The modified DNA chain and therefore the genetically manipulated heredity factor is multiplied by fermentation of the icroorganisms. The DNA chain with the modified gene and the substances which it produces develop simultaneously. The desired cell products may be contained intra- or extracellularly.
Extracellular products
After fermentation, the microorganisms are extracted by continuously operating separators. To increase the yield, the solid material is washed and extracted again by centrifuging. The clarified phases of the two stages are mixed and fed to further stages of the process. All material streams leaving this enclosed process must be sterilized at least 121 °C. To keep the process as simple as possible, the biomass is killed directly after fermentation in the fermenter either by heat or by chemical methods.
Completely enclosed, steam sterilized centrifuges are employed in this process and can be connected to the other equipment in a sterile manner.
Intracellular products and inclusion bodies
In intracellular processes, it is differentiated whether the desired product is contained in the intracellular liquid or in so-called inclusion bodies. In contrast to extracellular bioproduction, the clarified phase leaves the process here and the biomass is processed.
The washed and concentrated biomass is homogenized, i.e. the cells are broken down and the intracellular liquid and the inclusion bodies are released. These are separated from the cell fragments, washed and concentrated in further stages of the process by centrifuges from GEA Westfalia Separator. For intracellular products gained from the cell liquid, the solids are extracted by continuously operating separators.
Recovery of pharmaceutical protein