Validation of a Stability-indicating RP-LC Method for the Assessment of Recombinant Human Interleukin-11 and Its Correlation with Bioassay

Abstract

A stability-indicating reversed-phase liquid chromatography (RP-LC) method was validated for the assessment of recombinant human interleukin-11 (rhIL-11), based on the ICH guidelines. The method was carried out on a Jupiter C4 column (250 mm × 4.6 mm i.d.), maintained at 25 C. The mobile phase A consisted of 0.1% trifluoroacetic acid (TFA) and the mobile phase B was acetonitrile with 0.1% TFA, run at a flow rate of 1 mL/min, and using a photodiode array (PDA) detection at 214 nm. Separation was obtained with a retention time of 27.6 min, and was linear over the concentration range of 1-200 μg/mL (r 2 = 0.9995). Specificity was established in degradation studies, which also showed that there was no interference of the excipients. The accuracy was 100.22% with bias lower than 1.25%. Moreover, the in vitro cytotoxicity test of the degraded products showed non-significant differences (p > 0.05). The method was applied to the assessment of rhIL-11 and related proteins in biopharmaceutical dosage forms, and the results were correlated to those of a bioassay.

Designing recombinant Escherichia coli strain for expression of Interleukin-3 and Interleukin-11 in fusion form with PELB

“…Interleukin-11 (IL-11) là một cytokine thuộc họ Interleukin-6, đóng vai trò điều hòa sự nhân lên, biệt hóa và trưởng thành của nhiều loại tế bào máu. Theo Souto et al (2012) [ 6], protein IL-11 người tái tổ hợp sản xuất bằng công nghệ DNA tái tổ hợp từ chủng E. coli hiện nay được sử dụng trên toàn thế giới để phòng bệnh giảm tiểu cầu sau hóa trị liệu và giảm nhu cầu truyền tiểu cầu đối với bệnh nhân bị u tủy ác tính.…”