基于电荷变异体的人血白蛋白质量评价

A New Strategy for Quality Evaluation of Human Serum Albumin Based on Charge Variants

关键词:  人血白蛋白  电荷变异体  纯度  质量评价  全柱成像毛细管等电聚焦电泳法

Key words:  human serum albumin(HSA)  charge variants  purity  quality evaluation  whole column imaging capillary isoelectric focusing electrophoresis(icIEF)

摘要:

目的 建立人血白蛋白电荷变异体的检测方法,为其质量评价提供新的科学依据和策略。方法 采用全柱成像毛细管等电聚焦电泳(icIEF)法,通过考察尿素浓度、两性电解质范围和聚焦时间,建立了人血白蛋白电荷变异体的检测方法,并对50批产品进行质量分析。结果 人血白蛋白主要有PI5.5-5.6、PI4.9-5.0、PI5.2三种电荷变异体,其中PI5.5-5.6占比大于80%。50批人血白蛋白样品测定结果表明电荷变异体含量较凝胶电泳检测结果更能反映出产品的批间差异。结论 电荷变异体检测可用于评价人血白蛋白的批间差异和生产工艺稳定性。

Abstract:

OBJECTIVE To establish a detection method for human serum albumin(HSA) charge variants and provide new scientific basis and strategies for their quality evaluation. METHODS The whole column imaging capillary isoelectric focusing electrophoresis (icIEF) technology was employed to establish a detection method for HSA charge variants. This was achieved by examining urea concentration, range of zwitterionic electrolytes, and focusing time. Quality analysis was conducted on 50 batches of products. RESULTS The main charge variants of HSA are PI5.5-5.6, PI4.9-5.0, and PI5.2, with PI5.5-5.6 accounting for over 80%. The results of 50 batches of HSA showed that the content of charge variants could reflect the inter-batch variability more accurately than that of gel electrophoresis. CONCLUSION Charge variant detection can be used to evaluate inter-batch variability and production process stability of HSA.