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.
Development and scale-up of downstream processing sequences
Optimization of downstream processing sequences by multifactorial (DoE) approaches
High-throughput process development
Development of protein renaturation processes
Validation of critical process parameters
Development and verification of cleaning procedures for reusable equipment parts that are in direct contact with the process stream
Processing of technical (non-GMP) batches
Methods and hardware
Protein refolding up to 1000-l scale
Protein extraction with aqueous two-phase systems
Solid/liquid separation by centrifugation, cross-flow micro- and ultrafiltration (membrane area up to 6 m²), and dead-end filtration
Preparative process chromatography; modes: IEX, HIC, TAC, affinity, GPC
Chromatography hardware: ÄKTAexplorers 10 and 100, ÄKTAavant, ÄKTApilot, BioProcess, columns with diameters up to 30 cm