| abstract |
The present disclosure relates to the use of host cell protein biomarkers to assess disulfide bond reduction in compositions comprising a protein of interest. In some embodiments, the disclosure comprises a protein of interest, which measures the level of expression or activity of at least one host cell protein to provide a reference value associated with the reduction of disulfide bonds of the protein of interest or the occurrence of low molecular weight species. It relates to a method for predicting the occurrence of disulfide bond reduction or low molecular weight protein species in a composition. In some embodiments, the disclosure provides information on culturing a host cell capable of producing a protein of interest, measuring the level of expression or activity of at least one host cell protein, and downstream isolation of the protein of interest by means of host cell protein measurements. It relates to a method of producing a protein of interest, providing a. |