کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
7609476 1493399 2017 10 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Column-to-column packing variation of disposable pre-packed columns for protein chromatography
ترجمه فارسی عنوان
تناوب بسته بندی ستون به ستون از ستون های بسته بندی شده یکبار مصرف برای کروماتوگرافی پروتئین
کلمات کلیدی
کروماتوگرافی آماده سازی تجزیه و تحلیل قله، صلاحیت ستون، دقت اندازه گیری، تنوع بسته بندی، هندسه ستون، نسبت ابعاد، عملکرد ستون،
موضوعات مرتبط
مهندسی و علوم پایه شیمی شیمی آنالیزی یا شیمی تجزیه
چکیده انگلیسی
In the biopharmaceutical industry, pre-packed columns are the standard for process development, but they must be qualified before use in experimental studies to confirm the required performance of the packed bed. Column qualification is commonly done by pulse response experiments and depends highly on the experimental testing conditions. Additionally, the peak analysis method, the variation in the 3D packing structure of the bed, and the measurement precision of the workstation influence the outcome of qualification runs. While a full body of literature on these factors is available for HPLC columns, no comparable studies exist for preparative columns for protein chromatography. We quantified the influence of these parameters for commercially available pre-packed and self-packed columns of disposable and non-disposable design. Pulse response experiments were performed on 105 preparative chromatography columns with volumes of 0.2-20 ml. The analyte acetone was studied at six different superficial velocities (30, 60, 100, 150, 250 and 500 cm/h). The column-to-column packing variation between disposable pre-packed columns of different diameter-length combinations varied by 10-15%, which was acceptable for the intended use. The column-to-column variation cannot be explained by the packing density, but is interpreted as a difference in particle arrangement in the column. Since it was possible to determine differences in the column-to-column performance, we concluded that the columns were well-packed. The measurement precision of the chromatography workstation was independent of the column volume and was in a range of ± 0.01 ml for the first peak moment and ± 0.007 ml2 for the second moment. The measurement precision must be considered for small columns in the range of 2 ml or less. The efficiency of disposable pre-packed columns was equal or better than that of self-packed columns.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Chromatography A - Volume 1527, 8 December 2017, Pages 70-79
نویسندگان
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