Standardization and validation of molecular size distribution test for human immunoglobulin products in Korea

• 발행기관: 대한약학회
• 저자명: Chan Woong Choi Ka Young Kim Ho-Jin Song Kiwon Han Seungwan Jee and Jaeok Kim
• 간행물 정보: 『약학회지』제65권 제1호(2021년), 23~30쪽, 전체 8쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2021.02.28

영문 초록

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.

목차

Introduction

Methods

Results

Discussion

Conclusion

Acknowledgment

Conflict of Interest

References

키워드

Korean minimum requirements for biological products molecular size distribution human immunoglobulin plasma-derived product validation quality control