Establishment of a reference material for standardization of the anti-complementary activity test in intravenous immunoglobulin products used in Japan: A collaborative study

• Published in: Biologicals Vol. 46; pp. 68 - 73
• Main Authors: Nojima, Kiyoko, Okuma, Kazu, Ochiai, Masaki, Kuramitsu, Madoka, Tezuka, Kenta, Ishii, Mieko, Ueda, Sadao, Miyamoto, Takashi, Kamimura, Koichiro, Kou, Enki, Uchida, Sanae, Watanabe, Yoshiharu, Okada, Yoshiaki, Hamaguchi, Isao
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.03.2017
• Subjects: Animals; Anti-complementary activity; bioassays; Biological Assay - methods; Biological Assay - standards; Calibration; complement; Complement Activation - drug effects; Complement Inactivating Agents - pharmacology; Complement Inactivating Agents - standards; Cooperative Behavior; Guinea Pigs; Humans; immunoglobulins; Immunoglobulins, Intravenous - pharmacology; Immunoglobulins, Intravenous - standards; intravenous injection; Japan; Laboratories - standards; Quality Control; Reference material; Reference Standards; Reproducibility of Results; risk; Sheep; Standardization; Japan; Reference material; Anti-complementary activity; Standardization

Aggregates of human plasma-derived intravenous immunoglobulins (IVIGs) carries a risk of severe adverse events after nonspecific complement activation induced in humans administrated. Therefore, the anti-complementary activity (ACA) test is legally required in every batch of IVIGs in Japan. However,...