In this study, we aimed to harmonize and compare the molecular size distribution test in Korean Minimum Requirements for Biological Products (KMRBP) and the European Pharmacopeia (Ph. Eur.). Size-exclusion highperformance liquid chromatography methods in the KMRBP and Ph. Eur. were compared using a human immunoglobulin reference standard. The operating conditions were standardized and the method was validated. The validated and current KMRBP methods were used to analyze seven types of human immunoglobulin products approved in Korea. The coefficient of variation (CV) level was set to ≤1% for monomer/dimer and ≤10% for polymers/aggregates, indicating no difference between the results. The peak areas of monomer/dimer and polymers/aggregates showed no difference when different operating conditions, including the mobile phase, sample dilution buffer, and flow rate, were used to conduct the procedures listed in the KMRBP and Ph. Eur. However, the CV for polymers/aggregates was determined to be more than 10 % when columns of different sizes were used. In the validation studies, the CV for peak areas of monomer/dimer and polymers/aggregates were determined to be ≤1 and ≤10%, respectively. The results indicated that both methods were suitable as per the specifications of the Ph. Eur. and KMRBP. Quality control of human immunoglobulin products is crucial to ensure their safety and efficacy. The present study provides a scientific basis for the new national lot release test of molecular size distribution for human immunoglobulin products adopted by the KMRBP.
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Conflict of Interest
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