[Validation of a method for monitoring of genetically engineered human insulin manufacture].
A method for monitoring the manufacture of genetically engineered human insulin by HPLC was developed. The method was validated by the estimation of its linearity, correctness, accuracy, specificity, and stability; the limits of detection and quantitative assessment were also determined. It was proven that HPLC analysis enables reliable and reproducible results to be obtained and can be used for monitoring insulin manufacture.
D A
DA
Gusarov
V D
VD
Gusarova
A V
AV
Mikhalev
V A
VA
Lasman
D I
DI
Bairamashvili
A F
AF
Mironov
N K
NK
Senatorova
A V
AV
Senatorov
D004340:Drug Contamination / Q000517:prevention & control*; D005818:Genetic Engineering; D006801:Humans; D007328:Insulin / Q000737:chemistry* / Q000235:genetics; D011786:Quality Control; D011994:Recombinant Proteins / Q000737:chemistry / Q000235:genetics; D012015:Reference Standards
D007328:Insulin; D011994:Recombinant Proteins