Matrix effect on the determination of Potency in Recombinant Coagulation Factor Ⅷ for injection
10.13303/j.cjbt.issn.1004-549x.2022.12.018
- VernacularTitle:基质效应对注射用重组人凝血因子Ⅷ效价检测方法的影响
- Author:
Jialin CHU
1
;
Yaling DING
1
;
Wenhu HUANG
1
;
Jiajun WU
1
;
Xiao JIANG
1
;
Yang GAO
1
;
Xun LIU
1
;
Shenghua DU
1
;
Yizhou XIE
1
Author Information
1. Chengdu Rongsheng Pharmaceuticals Co, ChengDu 610041, China
- Publication Type:Journal Article
- Keywords:
recombinant human coagulation factor Ⅷ;
rFⅧ;
matrix effect
- From:
Chinese Journal of Blood Transfusion
2022;35(12):1262-1265
- CountryChina
- Language:Chinese
-
Abstract:
【Objective】 To investigate the matrix effect on the determination of potency in Recombinant Human Coagulation Factor Ⅷ for Injection (rFⅧ). 【Methods】 Two different detection matrices were used to establish two methods for detecting the potency in Recombinant Human Coagulation Factor Ⅷ for Injection. And the matrix effect on the determination of potency was determined, including specificity, linearity, repeatability, accuracy and intermediate precision. 【Results】 As to the specificity, the recoveries of the two substrates at high vs low concentration level were 112% and 110% vs 104% and 109%, respectively. As to the linearity, in the range of (0.125-1.000) IU/mL, the correlation coefficient between concentration and coagulation time of standard/ sample was higher than 0.99. As to the accuracy/repeatability, the recoveries of two matrices was 104% and 102%, and RSD was 2.4% and 1.9%. As to the intermediate precision, personnel factor of two matrices was 0.72 and 0.23, date factor was 0.79 and 0.85, and RSD(for 12 times) was 4.2% and 3.0%. Comparison of two matrices was as follows: Deviation in test results of 6 batches of rFⅧ was all lower than 5%. There was no significant difference between two matrices. 【Conclusion】 The two matrices for potency detection show good performance including specificity, linearity, repeatability, accuracy, and intermediate precision. They are suitable for the determination of potency in rFⅧ products.
