Metabolic enzyme activity and disulfide bond reduction during protein production

摘要

This disclosure relates to the use of a host cell protein biomarker to evaluate disulfide bond reduction in a composition containing a desired protein.In some embodiments, the disclosure relates to a method for predicting the formation of a disulfide bond reduction or a low molecular weight protein species in a composition containing a desired protein, where the expression or activity level of at least one host cell protein is measured and It also provides a benchmark value associated with the disulfide bond reduction or the generation of low molecular weight species for the purpose proteins.In some embodiments, the disclosure relates to a method of producing a desired protein, wherein the host cell capable of producing the desired protein is cultured and the expression or activity level of at least one host cell protein is measured The downstream isolation of the target protein is known by host cell protein measurements.