Format

Send to

Choose Destination
Toxicol Res. 2017 Jul;33(3):225-231. doi: 10.5487/TR.2017.33.3.225. Epub 2017 Jul 15.

Stability Evaluation of National Reference Standards for Blood Products in Korea.

Author information

1
Biologics Research Division, National Institute of Food and Drug Safety Evaluation, Cheongju, Korea.
2
Blood Products Division, National Institute of Food and Drug Safety Evaluation, Cheongju, Korea.

Abstract

National reference standards (NRSs) for biologics are established through potency estimation by a multicenter joint study of standard materials used in the approval process for national lot release and quality control of vaccines, blood products, and other biologics. In this study, a stability evaluation was conducted to determine whether the potency of NRSs for six blood products was being maintained at a consistent level in Korea. The present study conducted real-time stability tests via in-vivo/in-vitro bioassay on NRSs for blood coagulation factor VIII concentrate (2nd standard), antithrombin concentrate, prekallikrein activator, anti-hepatitis B immunoglobulin, blood coagulation factor IX concentrate, and anti-tetanus human immunoglobulin, as well as a trend analysis using cumulative annual results. The real-time stability test results showed that the mean potency of six NRSs was all within the control limit. In the trend analysis, the potency of NRS for blood coagulation factor VIII concentrate (2nd standard) showed a decreasing trend, while the potency of all other products had been stably maintained. The present study confirmed that the mean potency of NRSs for six blood products had been stably maintained in Korea. The findings of the present study establish a foundation that can ensure the quality of NRSs for biologics in Korea, and it is expected to make a major contribution to the supply of high-quality biologics.

KEYWORDS:

Blood product; National reference standard; Real-time stability test; Trend analysis

Conflict of interest statement

CONFLICT OF INTEREST The authors have disclosed no conflicts of interest.

Supplemental Content

Full text links

Icon for PubMed Central
Loading ...
Support Center