Chinese hamster ovary (CHO) cells are integral to the $125 billion biopharmaceutical market, which includes monoclonal antibodies (mAbs) and other therapeutic proteins. Recent sequencing of the Chinese hamster and Chinese hamster ovary (CHO) cell genomes enables cell engineering strategies to address a wide variety of problems encountered in biopharmaceutical manufacturing. One particular application involves studies of CHO host cell proteins (HCPs) that may be difficult to remove for a variety of reasons. The presence of HCPs is regulated for patient safety concerns but may also have an impact on product quality in the context of formulation.
Polysorbates are a class of non-ionic surfactants that are added to biopharmaceutical formulations to improve the stability of therapeutic proteins by limiting aggregation and surface adsorption. Monoclonal antibody formulations often incorporate a polysorbate such as polysorbate 80 (PS-80) and polysorbate 20 (PS-20) to prolong the shelf-life of drug products. Polysorbate degradation over time can impact the stability of those drug products.
There remains a need for improved mammalian host cells for producing stable recombinant proteins by, for example, mitigating polysorbate degradation.