论文部分内容阅读
采用分子排阻色谱(SEC)法测定静注人免疫球蛋白(pH 4)分子大小分布时,在Ig G二聚体和多聚体峰之间发现一未知组分。本研究采用质谱技术分析该未知组分的蛋白质信息。以SEC法分离收集来自4个厂家样品中的该未知组分,经除盐、浓缩和酶解,将获得的肽段采用nano-LC-MS/MS法鉴定蛋白质。结果显示,3个企业样品中的未知组分除含有Ig G外还含有其他杂蛋白,另1企业样品中的未知组分主要为Ig G亚类。将nano-LC-MS/MS获得的未知组分蛋白质信息建立杂蛋白谱数据库,可为药品监管服务。
An unidentified component was found between the Ig G dimer and the multimer peak when size distribution of the immunoglobulin (pH 4) was measured by size exclusion chromatography (SEC). In this study, we used mass spectrometry to analyze the protein information of this unknown component. The unknown components in samples collected from 4 factories were separated and collected by SEC method. The obtained peptides were identified by nano-LC-MS / MS after desalting, concentration and enzymolysis. The results showed that the unknown components of the three samples contained other hybrid proteins in addition to Ig G and the unknown components in the other samples of the enterprise were mainly Ig G subtypes. The nano-LC-MS / MS to obtain unknown components of protein information to establish hybrid protein spectrum database for drug regulatory services.