کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
1199397 1493567 2014 12 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Modeling and robust pooling design of a preparative cation-exchange chromatography step for purification of monoclonal antibody monomer from aggregates
ترجمه فارسی عنوان
مدلسازی و طراحی جامدسازی یک گام کروماتوگرافی کاتیونی آماده سازی برای تمیز کردن مونومر آنتی بادی مونوکلونال از مشتقات
کلمات کلیدی
مدلسازی کروماتوگرافی، ایزوترم جذب، آنتیبادیهای مونوکلونال، حذف کامل کنترل فرایند، جمع آوری محصول
موضوعات مرتبط
مهندسی و علوم پایه شیمی شیمی آنالیزی یا شیمی تجزیه
چکیده انگلیسی


• A general rate model with temperature dependent diffusion describes the transport.
• A pH- and temperature-dependent steric mass action model describes the adsorption.
• The retention between a pH of 4.8 and 5.5 and between 18 °C and 25 °C was reproduced.
• The purity, sodium concentration, and temperature are the most important parameters.
• The model is used to establish an elution end collection criterion.

This study has implemented and calibrated a model that describes the separation of the monomer of monoclonal antibodies from the dimer and larger oligomers on preparative-scale using cation-exchange chromatography. A general rate model with temperature dependent diffusion was coupled to a pH- and temperature-dependent steric mass action model. The model was shown to predict the retention of the monomer, dimer, and oligomer at low loadings for different pH levels and temperatures. Additionally, the model was shown to adequately predict the elution behavior of the monomer and soluble aggregates at high loadings within the same ranges with some limitations. The model was not able to accurately describe the shape of the product break-through curves or the slight levels of co-elution of the dimer and oligomer with the monomer at higher pH. The model was used to predict how 12 process variations impact the separation. The model is used to establish an elution end collection criterion such that the step can robustly provide the target purity of monomers.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Chromatography A - Volume 1359, 12 September 2014, Pages 170–181
نویسندگان
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