Evaluation of recombinant human interferon beta 1b by liquid chromatography methods and bioassay

Recombinant human interferon beta 1b (rhIFNß-1b) is clinically used to treat multiple sclerosis. A reversed-phase liquid chromatography (RP-LC) method was carried out on a Jupiter C4 column (250 mm × 4.6 mm i.d.). The mobile phase A consisted of 0.1% trifluoroacetic acid (TFA) in water, and the mobile phase B was acetonitrile with 0.1% TFA run at a flow rate of 1.0 mL/min. A size exclusion liquid chromatography (SE-LC) method was carried out on a BioSep-SEC-S 2000 column (300 mm × 7.8 mm i.d.). The mobile phase consisted of 1 mM monobasic potassium phosphate, 8 mM sodium phosphate dibasic and 200 mM sodium chloride buffer pH 7.4, run isocratically at a flow rate of 0.8 mL/min. Retention times were 31.87 and 17.78 min, and calibration curves were linear over the concentration range of 1-200 µg/mL (r2 = 0.9998) and 0.50-200 µg/mL (r2 = 0.9999), respectively, for RP-LC and SE-LC, with detection at 214 nm. Liquid chromatography (LC) methods were validated and employed in conjunction with the in vitro bioassay to assess the content/potency of rhIFNß-1b, contributing to improve the quality control and to ensure the efficacy of the biotherapeutic

Intervention effect discussion of recombinant human interferon beta-1b for injection in the treatment of relapsing remitting multiple sclerosis / 中国医师进修杂志

Objective To explore the clinical efficacy and safety of recombinant human interferon beta-1b for injection (rhINFβ-1b) in the treatment of relapsing remitting multiple sclerosis (RRMS). Methods Thirty patients with RRMS were selected. According to the condition of accepting rhINFβ-1b for treatment, they were divided into intensification treatment group (11 cases) and routine treatment group (19 cases). They were followed up for 24 months, all the patients′laboratory examination and imaging examination were performed. The scores of clinical extended disability scale (EDSS) and the number of recurrences were compared between the two groups before and after the treatment. In the initial admission (T0), at the end of treatment (T1), 6 months of follow-up (T2), 12 months of follow-up (T3) and 18 months of follow-up (T4), the sequence of MRI T2and the number of enhanced scan lesions were observed, and the adverse drug reactions and their severity were evaluated. The ROC curve of cystatin C level in cerebrospinal fluid(CSF) was drawn to comprehensively evaluate the efficacy of drug intervention. Results After treatment, the scores of EDSS in intensification treatment group were significantly decreased (P < 0.05). The scores of EDSS and the number of annual recurrence in intensification treatment group were significantly lower than those in conventional treatment group: (1.59 ± 0.75) scores vs. (4.07 ± 0.95) scores, (0.93 ± 0.38) times/year vs. (2.41 ± 0.54) times/year, there were significant differences (P＜0.01). The number of lesions at T0-T4time point in T2sequence and enhanced scan focus in intensification treatment group decreased. However, in conventional treatment group the number of lesions in T2sequences at T0-T4time point showed an upward trend, and the number of lesions at enhanced scan showed a broken line fluctuation. The results ROC curve showed that the area under the curve of intensification treatment group was 0.947 and the area under the conventional treatment group was 0.899. Conclusions rhINFβ-1b can effectively improve symptoms, significantly reduce the clinical relapse and MRI active lesions in patients with RRMS, slow down the progression of the disease, and have fewer adverse reactions.