Preparation of national standard for enterovirus 71 immunoglobulin / 中国药学杂志

ABSTRACT

OBJECTIVE: To prepare the first batch of national standard for enterovirus 71 immunoglobulin for the efficacy test of EV71 human immunology products. METHODS: The domestic intravenous immunoglobulin products with batch release certification and high efficacy EV71 immunoglobulin products were mixed, filled, and lyophilized under aseptic conditions to get the first batch of national standard for enterovirus 71 immunoglobulin. The standards were distributed to five laboratories for cooperative calibration according to the unified SOP for microneutralization test. Neutralizing titer which corresponded to the reciprocal of the highest serum dilution that neutralized enterovirus 71 was defined as the efficacy (reported as unit) of the national standard. Sterility test, moisture determination, precision for filling test, and stability of potency were verified. RESULTS: A total of 63 calibration tests were earned out by the five collaboration laboratories, and the results were statistically analyzed after logistic convertion. The inter-laboratories variations varied from 1.5%-4.1% and the intra-laboratories variation was 3.1%. The geometric mean of the prepared national EV71 immunoglobulin standard was 327 U and defined as 330 U for convenience of use. The potency of the prepared standard was stable after 22 m and the contents of monomer plus dimer determined by HPLC-SEC were more than 98.0% during storage at a wide range of temperatures. The prepared national EV71 immunoglobulin standard was qualified in the sterility test, and the moisture content and precision for filling were 0.6% and 0.56%, respectively. CONCLUSION: The prepared national EV71 immunoglobulin standard met all the relevant requirements and may be served as the first generation of national standard for the potency test of EV71 immunoglobulin products.