Preventing Aggregation of Rrecombinant Interferon Beta-1b in Solution by Additives: Approach to an Albumin-Free Formulation
Author(s):
Abstract:
Purpose
Aggregation suppressing additives have been used to stabilize proteins duringmanufacturing and storage. Interferonβ-1b is prone to aggregation because of being nonglycosylated.Aggregation behavior of albumin-free formulations of recombinant IFNβ-1bwas explored using additives such as n-dodecyl-β-D-maltoside, Tween 20, arginine,glycine, trehalose and sucrose at different pH.Methods
Fractional factorial design was applied to select major factors affectingaggregation in solutions. Box-Behnken technique was used to optimize the bestconcentration of additives and protein.Results
Quadratic model was the best fitted model for particle size, OD350 andOD280/OD260. The optimal conditions of 0.2% n-Dodecyl-β-D-maltoside, 70 mMarginine, 189 mM trehalose and protein concentration of 0.50 mg/ml at pH 4 were achieved.A potency value of 91% ± 5% was obtained for the optimized formulation.Conclusion
This study shows that the combination of n-Dodecyl-β-D-maltoside, arginineand trehalose would demonstrate a significant stabilizing and anti-aggregating effect on theliquid formulation of interferonβ-1b. It can not only reduce the manufacturing costs but willalso ease patient compliance.Keywords:
n , Dodecyl , ? D , maltoside , Optimization , HSA , free formulation , Aggregation , Box , Behnken experimental design
Language:
English
Published:
Advanced Pharmaceutical Bulletin, Volume:5 Issue: 4, Nov 2015
Pages:
497 to 505
magiran.com/p1479248
دانلود و مطالعه متن این مقاله با یکی از روشهای زیر امکان پذیر است:
اشتراک شخصی
با عضویت و پرداخت آنلاین حق اشتراک یکساله به مبلغ 1,390,000ريال میتوانید 70 عنوان مطلب دانلود کنید!
اشتراک سازمانی
به کتابخانه دانشگاه یا محل کار خود پیشنهاد کنید تا اشتراک سازمانی این پایگاه را برای دسترسی نامحدود همه کاربران به متن مطالب تهیه نمایند!
توجه!
- حق عضویت دریافتی صرف حمایت از نشریات عضو و نگهداری، تکمیل و توسعه مگیران میشود.
- پرداخت حق اشتراک و دانلود مقالات اجازه بازنشر آن در سایر رسانههای چاپی و دیجیتال را به کاربر نمیدهد.
In order to view content subscription is required
Personal subscription
Subscribe magiran.com for 70 € euros via PayPal and download 70 articles during a year.
Organization subscription
Please contact us to subscribe your university or library for unlimited access!