Shin In Soo, Hong Choong Man, Ban Sang Ja, Hong Seung Hwa
National Center for Lot Release, National Institute of Food and Drug Safety Evaluation, Korea Food and Drug Administration, Ohsong Bio Complex 643 Yeonje-ri, Kangwei-myeon, Chungwon-kun, Chungbuk-do 363-951, Republic of Korea.
Biologicals. 2012 Jan;40(1):79-83. doi: 10.1016/j.biologicals.2011.10.010. Epub 2011 Nov 27.
The aim of this study was to establish the first national standard for prekallikrein activator (PKA) calibrating to the first international standard PKA. A collaborative study among five laboratories, including three manufacturers and two national control laboratories, was carried out to evaluate the suitability of a candidate to serve as a national standard of PKA. The candidate was manufactured in GMP facility following approved human serum albumin fractionation procedure and freeze-dried 5% albumin solution containing PKA. Participants were provided with sufficient samples and asked to use lab-made prekallikrein substrate prepared in accordance with European Pharmacopeia and also to use a commercial prekallikrein provided as part of the study. The PKA concentration of the candidate was 61.8 IU per vial using lab-made prekallikrein. However, the concentration was 54.2 IU per vial using commercial prekallikrein. The variability obtained at each laboratory ranged from 1.9% to 5.1% for within-a-day and from 5.6% to 9.0% for day-to-day. The candidate showed excellent stability from accelerated degradation study and real-time stability study. As a conclusion, the candidate preparation was suitable to serve as a Korean National Standard for PKA.
本研究的目的是建立首个校准至首个国际标准前激肽释放酶激活剂（PKA）的国家标准。开展了一项由五个实验室（包括三家制造商和两家国家对照实验室）参与的协作研究，以评估一种候选品作为PKA国家标准的适用性。该候选品在符合药品生产质量管理规范（GMP）的设施中按照批准的人血清白蛋白分级分离程序生产，并冻干含有PKA的5%白蛋白溶液。为参与者提供了足够的样品，并要求他们使用按照欧洲药典制备的实验室自制前激肽释放酶底物，同时使用作为研究一部分提供的市售前激肽释放酶。使用实验室自制前激肽释放酶时，候选品的PKA浓度为每瓶61.8国际单位（IU）。然而，使用市售前激肽释放酶时，浓度为每瓶54.2 IU。各实验室获得的日内变异性在1.9%至5.1%之间，日间变异性在5.6%至9.0%之间。从加速降解研究和实时稳定性研究来看，该候选品表现出优异的稳定性。结论是，该候选制剂适合作为韩国PKA国家标准。
