Abstract
AbstractBACKGROUNDChanges in glycosylation profiles of monoclonal antibodies can have significant impact upon the product quality. Control of critical process parameters in order to ensure consistent product quality is one of the core requirements of the FDA's QbD and PAT initiatives. The effect of operating conditions upon cell metabolism and the glycosylation profile of monoclonal antibody produced using hybridoma cell culture is investigated in this report.RESULTSPCA analysis of online process data and amino acid concentration profiles reflecting the cell metabolism indicates significant dependence on the operating conditions, particularly DO and pH. PLS models predicting product titre based on amino acid concentration and those predicting the glycosylation profile either based on product titre and glucose concentration or on amino acid concentrations show that both titre and glycosylation can be predicted with satisfactory accuracy for a range of operating conditions.CONCLUSIONSAccurate prediction of product titre and glycosylation profile based on amino acid concentration and process variables easily measured in real time opens up the opportunity to control the product quantity and quality during cultivation using critical process parameters, such as pH and DO. © 2014 Society of Chemical Industry
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