Statistic Process Analysis of Monoclonal Antibodies N-linked Glycosylation

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  Glycosylation can affect the bioactivity and therapeutic efficacy of the monoclonal antibody.In this paper,a simplified N-linked glycosylation model is given first,and a deep statistic process investigation is carried out at the micro-scale.The enzyme concentrations in cell are considered as the manipulated variables.The output variable is the glycan class distribution.The process gain matrix obtained based on statistically DOE and ANOVA strategy is used to catch the data relationship between the enzyme concentrations and the glycan distribution.Singular value decomposition of the process gain matrix can transform a high nonlinear system in the original space into a couple of SISO linear systems in the new coordinate space.Then the controllability can be analyzed in the latent variable space easily.
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