文献类型： 会议论文

第一作者： Anne Skaja Robinson

作者： Anne Skaja Robinson ¹ ; Yu Luo ² ; Devesh Radhakrishnan ³ ; Evan A. Wells ⁴ ; Liqing Song ⁴ ; Varghese Kurian ⁵ ; Babatunde A. Ogunnaike ⁵ ;

作者机构： 1.Department of Chemical Engineering, Carnegie Mellon University

2.University of Delaware

3.University of Delaware, BioMarin Pharmaceutical Inc

4.Carnegie Mellon University

5.Department of Chemical and Biomolecular Engineering, University of Delaware

关键词： Process control;State estimation;Quality by design;Open platform communications

会议名称： [ "Cell culture engineering conference" , "Cell Culture Engineering Conference"]

主办单位：

页码： 27-27

摘要： Therapeutic monoclonal antibodies (mAbs) are currently produced commercially in fed-batch cultures using media recipes and protocols based primarily on heuristics. The main production objectives are maximizing mAb titer (productivity) and achieving desired glycan distributions (quality attribute). The distribution of glycans is a critical quality attribute (CQA) of mAb manufacturing because it can either promote or inhibit the desirable therapeutic effects of mAb drugs. However, controlling glycosylation is challenging because it is a complex, non-template driven process that takes place within the cell. Consequently, the variables available for influencing glycosylation are far fewer than the controlled variables such that the process is challenging to model. In addition, on-line sensors do not currently exist for characterizing glycan distribution frequently enough for effective on-line control. Nevertheless, recent advances in both glycosylation modeling and glycan assays have improved the possibility of implementing model-based control of glycosylation in place of the current heuristics-based approach.

分类号： q813-53