title: Collaborative studies on the development of national reference standards for potency determination of H7N9 influenza vaccine.
abstract: The outbreak of human infections of a novel avian influenza virus A (H7N9) prompted the development of the vaccines against this virus. Like all types of influenza vaccines, H7N9 vaccine must be tested for its potency prior to being used in humans. However, the unavailability of international reference reagents for the potency determination of H7N9 vaccines substantially hinders the progress in vaccine development. To facilitate clinical development, we enlisted 5 participants in a collaborative study to develop critical reagents used in Single Radial Immunodiffusion (SRID), the currently acceptable assay for potency determination of influenza vaccine. Specifically, the hemagglutinin (HA) content of one vaccine bulk for influenza A (H7N9), herein designated as Primary Liquid Standard (PLS), was determined by SDS-PAGE. In addition, the freeze-dried antigen references derived from PLS were prepared to enhance the stability for long term storage. The final HA content of lyophilized antigen references were calibrated against PLS by SRID assay in a collaborative study. Importantly, application of these national reference standards to potency analyses greatly facilitated the development of H7N9 vaccines in China.
authors.affiliation: a National Institutes for Food and Drug Control, No.2 ; TiantanXili ; Beijing , PR China.
authors.forename: Changgui
authors.initials: C
authors.lastname: Li
authors.forename: Kangwei
authors.initials: K
authors.lastname: Xu
authors.forename: Anwar
authors.initials: A
authors.lastname: Hashem
authors.forename: Ming
authors.initials: M
authors.lastname: Shao
authors.forename: Shuzhen
authors.initials: S
authors.lastname: Liu
authors.forename: Yong
authors.initials: Y
authors.lastname: Zou
authors.forename: Qiang
authors.initials: Q
authors.lastname: Gao
authors.forename: Yongchao
authors.initials: Y
authors.lastname: Zhang
authors.forename: Liyong
authors.initials: L
authors.lastname: Yuan
authors.forename: Miao
authors.initials: M
authors.lastname: Xu
authors.forename: Xuguang
authors.initials: X
authors.lastname: Li
authors.forename: Junzhi
authors.initials: J
authors.lastname: Wang
mesh_terms: D000818:Animals; D002681:China; D019267:Hemagglutinin Glycoproteins, Influenza Virus / Q000276:immunology*; D006801:Humans; D005779:Immunodiffusion / Q000379:methods / Q000592:standards; D064766:Influenza A Virus, H7N9 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000276:immunology*; D012015:Reference Standards; D013678:Technology, Pharmaceutical / Q000379:methods / Q000592:standards*; D064166:Vaccine Potency
chemical_list: D019267:Hemagglutinin Glycoproteins, Influenza Virus; D007252:Influenza Vaccines
keywords: HA hemagglutinin; Hemagglutinin; Influenza virus A (H7N9); PLS Primary Liquid Standard; SDS-PAGE; SRID; SRID Single Radial Immunodiffusion; WHO World Health Organization; antigen reference standard