|
KMID : 0370220210650010023
|
|
Yakhak Hoeji
2021 Volume.65 No. 1 p.23 ~ p.30
|
|
|
Standardization and validation of molecular size distribution test for human immunoglobulin products in Korea
|
|
Choi Chan-Woong
Kim Ka-Young
Song Ho-Jin
Han Ki-Won
Jee Seung-Wan
Kim Jae-Ok
|
|
|
Abstract
|
|
|
|
In this study, we aimed to harmonize and compare the molecular size distribution test in Korean MinimumRequirements for Biological Products (KMRBP) and the European Pharmacopeia (Ph. Eur.). Size-exclusion highperformanceliquid chromatography methods in the KMRBP and Ph. Eur. were compared using a human immunoglobulinreference standard. The operating conditions were standardized and the method was validated. The validated and currentKMRBP methods were used to analyze seven types of human immunoglobulin products approved in Korea. Thecoefficient of variation (CV) level was set to ≤1% for monomer/dimer and ≤10% for polymers/aggregates, indicating nodifference between the results. The peak areas of monomer/dimer and polymers/aggregates showed no difference whendifferent operating conditions, including the mobile phase, sample dilution buffer, and flow rate, were used to conduct theprocedures listed in the KMRBP and Ph. Eur. However, the CV for polymers/aggregates was determined to be more than10 % when columns of different sizes were used. In the validation studies, the CV for peak areas of monomer/dimer andpolymers/aggregates were determined to be ≤1 and ≤10%, respectively. The results indicated that both methods weresuitable as per the specifications of the Ph. Eur. and KMRBP. Quality control of human immunoglobulin products iscrucial to ensure their safety and efficacy. The present study provides a scientific basis for the new national lot releasetest of molecular size distribution for human immunoglobulin products adopted by the KMRBP.
|
|
|
KEYWORD
|
|
|
Korean minimum requirements for biological products, molecular size distribution, human immunoglobulin, plasma-derived product, validation, quality control
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|