Development of robust upstream and downstream sequences with subsequent upscaling

Upstream: Mammalian cell culture

Fraunhofer ITEM develops robust and reliable suspension culture processes in both single-use and multiple-use cultivation systems. A focus is on scalability from laboratory to technical scale, and on evaluation and validation of process parameters.

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Upstream: Microbial cultivation

Fraunhofer ITEM develops robust and reliable microbial cultivation processes (bacteria, fungi, and yeasts) from laboratory scale to pilot scale with state of-the-art primary recovery/harvesting tools, evaluation and validation of process parameters.

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Downstream

Regardless of whether the target molecules were isolated from microbial or mammalian cells, and of whether the target molecules were secreted into culture supernatant or produced intracellularly, each individual step will undergo optimization and validation with respect to purity, yield, and the working range of parameters.

Fraunhofer ITEM is focused on fast process development of robust downstream processing sequences, the translation of laboratory-scale unit operations into technical scale, the validation of process parameters, and the manufacture of active biopharmaceutical ingredients such as recombinant proteins, antibodies, antibody fragments, plasmids, virus-like particles, and phages.

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