Abstract
Quantification of intracellular nucleotide sugars and formulation of a mathematical model for prediction of their metabolism
Highlights
The US FDA and the European Medicines Agency have recently proposed the implementation of the Quality by Design (QbD) paradigm to the manufacture of biopharmaceuticals
Several reports have shown that glycosylation is directly affected by the intracellular availability of nucleotide sugar donors (NSDs) [4] which are the cosubstrates for the glycosylation reactions that occur in the Golgi apparatus
In order to relate NSD metabolism with macroscopic cell culture variables, a model for cell growth, nutrient depletion, metabolite accumulation and product secretion was formulated based on conventional Monod kinetics
Summary
The US FDA and the European Medicines Agency have recently proposed the implementation of the Quality by Design (QbD) paradigm to the manufacture of biopharmaceuticals. Cells synthesize all the relevant NSDs from glucose through the nucleotide sugar metabolic pathway. In order to relate NSD metabolism with macroscopic cell culture variables, a model for cell growth, nutrient depletion, metabolite accumulation and product secretion was formulated based on conventional Monod kinetics.
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