Abstract: PREPARATION OF INSULIN QUALITY CONTROL SERA FOR RADIOIMMUNOASSAYShen Hongzheng Huang Ying Peng Xinjie(National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050)ABSTRACTAntiinsulin sera are obtained from male guinea pigs immunized with porcine insulin and are used for preparation of affinity chromatographic column. The column is packed with CNBractivated Sepharose 4B coupling with antiinsulin sera. When normal human sera are passing through the affinity chromatographic column, insulin is adsorbed on the column. After passed through the column, these sera are insulin free by RIA and protein composition of the sera is similar to that before the treatment by cellulose acetate of membrane electropharesis. The insulin quality control (QC) sera is prepared using insulin free sera in which human insulin added quantitativelly. The QC sera (low, medium and high concentration) are calibrated, and the reference values and their limits are obtained from statistical results of calibration.Key words insulin quality control sera affinity chromatographic column