Evaluation of the Exploitability of High Monoclonal Antibodies based on Polyethylene Glycol Precipitation
Abstrace The solubility,thermal stability,colloidal stability and other stability related properties of monoclonal antibodies were studied by high throughput method,and a stability prediction method was established to rapidly evaluate the developability of mono-clonal antibodies.By utilizing combinations of high throughput methods including Polyethylene glycol(PEG)precipitation method,Diffusion Interaction Parameter(kD)and Kirkwood-Buff integrals(G22)analysis by DLS,the solubility,colloidal stability and thermal stability of monoclonal antibodies were predicted and then confirmed by the preliminary stability study.In this study,a preliminary method for predicting the stability of monoclonal antibodies at high concentrations was established by combining kD,G22,Cmid and other indicators determined by high-throughput methods.The predicted optimal formulation conditions(20 mmol/L Histidine-HCl,200 mmol/L ArgCl,pH6.0)ensured the solubility and colloidal stability of the monoclonal antibody product at high concentrations,which was also confirmed by the accelerated stability study.This study provides a basis for predicting the preliminary stability of mAbs by using a variety of high-throughput predictor combinations,which would help efficient formulation especially high-concentra-tion formulation development.
High concentration of monoclonal antibodyHigh throughputStabilitySolubilityPolyethylene glycol(PEG)precipita-tion methodProtein-to-protein interactions(PPI)
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