Monoclonal Antibody Physicochemical Characterization Method Study Based On Liquid Chromatographic Analysis

The monoclonal antibodies prepared by the company as the main research object are characterized physically and chemically by means of the platform of liquid chromatography (LC), in which the study contain general theory of testing method, method development, validation and comparison of different methods, release of product and stability investigation. The LC methods contain size exclusion chromatography (SEC), ion exchange chromatography (IEC) and reverse phase chromatography (RP).All of the methods are developed and optimized through application of basic processing that consist of selection of appropriate chromatographic column based on the characteristics of sample and research of sample pretreatment, sample loading, proportion of mobile phase and elution gradient at the period of trial testing. SEC and IEC have been validated strictly before they used to release product. The validation referred to the related guideline in ICH Q2 consist of specificity, limit of quantitation, linearity, accuracy, precision, range and durability and all the projects conform to the laws and regulations request. UPLC and HPLC have used to research PM of product. Results had no clear differences between the two methods, and the method of UPLC gave higher sensitivity and resolution. The findings of the application of LC in researching monoclonal antibodies has a high value in dairy testing and stability investigation in QC lab.