Consistent high product quality at low cost is one of the most
desired, yet challenging outcomes in the biopharmaceutical
industry. Many complexities and variation are involved in
each unit operation related to the cell line development, the
culture medium formulations, process raw materials and
culture scale up and purification processes. There has been a
tremendous amount of research that focuses on maximizing
productivity of mammalian cells that produce therapeutic
proteins. High phenotypic heterogeneity is observed during
cell culture due to the varying progression in cell cycle,
imperfect mixing, and genetic variation. Robust
determination of cell cycle distribution in mammalian cell
culture processes is thus critical and can be directly translated
to knowledge to improve productivity of the culture.