title: Establishing the 1st Chinese National Standard for inactivated hepatitis A vaccine.
abstract: A reference standard calibrated in the International Units is needed for the quality control of hepatitis A vaccine. Thus, National Institutes for Food and Drug Control launched a project to establish a non-adsorbed inactivated hepatitis A vaccine reference as the working standard calibrated against the 1st International Standard (IS). Two national standard candidates (NSCs) were obtained from two manufacturers, and designated as NSC A (lyophilized form) and NSC B (liquid form). Six laboratories participated in the collaborative study and were asked to use their in-house validated enzyme-linked immunosorbent assay methods to detect hepatitis A vaccine antigen content. Although both exhibited good parallelism and linear relationship with IS, NSC B showed a better agreement among laboratories than NSC A. And based on suitability of the candidates, NSC B was selected. The accelerated degradation study showed that NSC B was stable at the storage temperature (≤-70 °C). Therefore NSC B was approved as the first Chinese national antigen standard for inactivated hepatitis A vaccine, with an assigned antigen content of 70 IU/ml.
authors.affiliation: National Institutes for Food and Drug Control, Beijing, PR China.
authors.forename: Fan
authors.initials: F
authors.lastname: Gao
authors.affiliation: National Institutes for Food and Drug Control, Beijing, PR China.
authors.forename: Qun-Ying
authors.initials: QY
authors.lastname: Mao
authors.affiliation: National Institutes for Food and Drug Control, Beijing, PR China.
authors.forename: Yi-Ping
authors.initials: YP
authors.lastname: Wang
authors.affiliation: National Institutes for Food and Drug Control, Beijing, PR China.
authors.forename: Pan
authors.initials: P
authors.lastname: Chen
authors.affiliation: National Institutes for Food and Drug Control, Beijing, PR China. Electronic address: lzhenglun@126.com.
authors.forename: Zheng-Lun
authors.initials: ZL
authors.lastname: Liang
mesh_terms: D002138:Calibration; D002681:China; D004355:Drug Stability; D004356:Drug Storage / Q000379:methods; D004797:Enzyme-Linked Immunosorbent Assay; D005612:Freeze Drying; D005615:Freezing; D035921:Hepatitis A Antigens / Q000276:immunology*; D022362:Hepatitis A Vaccines / Q000276:immunology* / Q000592:standards*; D006801:Humans; D007391:International Cooperation; D007753:Laboratories / Q000592:standards; D011786:Quality Control; D012015:Reference Standards; D015164:Vaccines, Inactivated / Q000276:immunology / Q000592:standards
chemical_list: D035921:Hepatitis A Antigens; D022362:Hepatitis A Vaccines; D015164:Vaccines, Inactivated
keywords: Antigen content; Collaborative study; Hepatitis A; Vaccine