Highlights•Mathematical models as tools to establish quantitative links between bioprocess
CPPs and KPIs.•Review of the advantages and limitations of mechanistic and statistical …

The N-linked glycan profiles on recombinant monoclonal antibody therapeutics significantly
affect antibody biological functions and are largely determined by host cell genotypes and …

Kinetic models offer incomparable insight on cellular mechanisms controlling protein
glycosylation. However, their ability to reproduce site-specific glycoform distributions …

Today's biomanufacturing processes are still operated based on experience, and thus can
hardly cope with increasing bioprocess complexity. Recently, there is a growing interest in …

The addition of nutrients and accumulation of metabolites in a fed-batch culture of Chinese
hamster ovary (CHO) cells leads to an increase in extracellular osmolality in late stage …

Highlights•3 waves of innovation have enhanced protein production in CHO cells.•Systems-
level methods are now unravelling drivers of protein production.•Predictive models will …

Kinetic modeling is the most suitable framework to describe the dynamic behavior of
mammalian cell culture although its industrial application is still in its infancy. Herein, the …

Exerting control over the glycan moieties of antibody therapeutics is highly desirable from a
product safety and batch‐to‐batch consistency perspective. Strategies to improve antibody …

Surface plasmon resonance (SPR)-based optical biosensors offer real-time and label-free
analysis of protein interactions, which has extensively contributed to the discovery and …

The clinical efficacy and safety of therapeutic monoclonal antibodies (mAbs) are significantly
affected by their Fc-glycosylation profile. High mannose-type N-glycans (HM) affect efficacy …