Mammalian cell culture processes used in the production of monoclonal and recombinant proteins require orthogonal steps in the downstream process to clear virus. Virus filtration is a common, size exclusion-based method in these processes. Initially, tangential flow products were used, but as a result of new-generation virus filtration products, most operations are now constant-pressure, normal-flow operations that can be executed in a single shift operation. The virus filtration step toward the end of the downstream process is now yielding increased protein concentrations…
Tag: <span>monoclonal antibodies</span>
In the last few decades, laboratory and therapeutic applications of cell culture-derived biologicals have expanded from their use in diagnostic and research fields to the prevention and treatment of infectious diseases, certain forms of cancer, immunological and congenital conditions, and cell and gene therapy. While significant therapeutic benefits obtained from the use of cell culture-derived biologics (e.g., recombinant proteins, monoclonal antibodies [mAb], and vaccines) are unequivocal, the complexities associated with the manufacture of such products is acknowledged. Primary and continuous cell lines used in the manufacture can be associated with risk of contamination with endogenous retroviruses, latent viruses, or new and emerging agents. Some cell lines, such as Chinese hamster ovary (CHO) cells, have an excellent safety record with no documented safety risks…
Agarose-based chromatography beads were first introduced by Stellan Hjertén in 1962. Fifty years later, beaded agarose has become the dominant resin for protein purification and is extensively used, ranging from research-scale in sub mL volumes to full-scale manufacturing in > 500 L chromatography columns. Recent resin development work has focused on increasing capacity and selectivity through different grafting technologies and ligand developments.