A collaborative study to establish the second national standard for antithrombin concentrate in Korea

Su Kyoung Seong; Hyun-Jung Koh; Hyun Jeong Kim; Yoojung Yi; Chan Woong Choi; In Soo Shin; Youngju Choi; Young Hoon Kim

doi:10.1016/j.biologicals.2024.101807

A collaborative study to establish the second national standard for antithrombin concentrate in Korea

Biologicals. 2024 Nov 21:89:101807. doi: 10.1016/j.biologicals.2024.101807. Online ahead of print.

Authors

Su Kyoung Seong¹, Hyun-Jung Koh², Hyun Jeong Kim², Yoojung Yi², Chan Woong Choi², In Soo Shin², Youngju Choi³, Young Hoon Kim⁴

Affiliations

¹ Blood Products Division, Biopharmaceuticals & Herbal Medicine Evaluation Department, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju-si, South Korea; Department of Life Science, University of Seoul, Seoul, South Korea.
² Blood Products Division, Biopharmaceuticals & Herbal Medicine Evaluation Department, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju-si, South Korea.
³ Biopharmaceuticals & Herbal Medicine Evaluation Department, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju-si, South Korea.
⁴ Blood Products Division, Biopharmaceuticals & Herbal Medicine Evaluation Department, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju-si, South Korea. Electronic address: k1631@korea.kr.

PMID: 39577355
DOI: 10.1016/j.biologicals.2024.101807

Abstract

This study aimed to establish a second national standard for antithrombin (AT) concentrate that can be used for potency assays of AT products. A collaborative study was conducted involving four laboratories, including national control laboratories and manufacturers in Korea, and the suitability of a candidate material to serve as the second national standard for AT concentrate was evaluated. The candidate material was manufactured using a process approved for Good Manufacturing Practices. The potency of the candidate was determined using the heparin cofactor chromogenic method. The candidate was calibrated against the third International Standard for AT concentrate (code 06/166). Participants provided data from 58 independent assays. Combined potency estimates were calculated by determining the geometric means of the results obtained from all assays performed at individual laboratories. The overall potency assessments were subsequently established as the geometric means of all results collected from all laboratories. According to the collaborative study results, the intra- and inter-laboratory variability showed acceptable geometric coefficient of variation of 1.2 %-3.4 % and 2.4 % respectively, and it deemed to serve as the Korean national standard for AT concentrate with the assigned potency as follows: 32.1 IU/vial (95 % confidence interval; 31.7-32.5 IU/vial).

Keywords: Antithrombin concentrate; Collaborative study; National standard.