earticle

영어

Polymeric aggregates formed during the manufacturing process of intravenous immunoglobulin (IVIG), as a result of protein interactions and further promoted by external factors such as pH shifts, temperature changes, or mechanical agitation can activate the complement system, potentially leading to severe adverse reactions. To mitigate such risks, the anticomplementary activity (ACA) test is employed to evaluate the safety of IVIG by measuring complement consumption following exposure to guinea pig complement. However, the ACA test described in the Korean Minimum Requirements for Biological Products differs from internationally recognized regulatory methods, highlighting the need for harmonization. This study aimed to validate the ACA test based on the European Pharmacopoeia and to establish an internationally harmonized protocol. Method validation confirmed that all analytical parameters met the required criteria. Following validation, the method was applied to assess ACA levels in five IVIG products, with testing conducted across three laboratories. The ACA levels ranged from 7.10% to 29.08%, all within the specified limits. This study provides a foundation for adopting the European Pharmacopoeia-based ACA test for national lot release and quality control of IVIG products. Moreover, it demonstrates the method’s applicability across various IVIG products and supports the global harmonization of testing practices, thereby enhancing international competitiveness.