Process parameters impacting product quality

Background and novelty Product quality is a result of the entire production process including protein sequence, cell substrate and process parameters. Many of the desired product properties are defined by posttranslational modifications with impact on biological activity, immunogenicity, half-life or stability. In-depth process understanding enables the targeted modulation of product quality attributes by rationally designed bioprocesses. This is valuable for new biological molecules in order to improve efficacy, reduce side effects, access new patient populations. For biosimilars this allows developing into defined quality attribute profiles. The identification of suitable process parameters and media compositions to modulate quality attributes is challenging due to the complexity of cell culture processes. Here, this challenge was approached by comprehensive data analysis, in-depth characterization of charge variant formation and high-throughput screening of process parameters and media compounds.