کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
1202304 965064 2011 8 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Direct determination of residual Pluronic F-68 in in-process samples from monoclonal antibody preparations by high performance liquid chromatography
موضوعات مرتبط
مهندسی و علوم پایه شیمی شیمی آنالیزی یا شیمی تجزیه
پیش نمایش صفحه اول مقاله
Direct determination of residual Pluronic F-68 in in-process samples from monoclonal antibody preparations by high performance liquid chromatography
چکیده انگلیسی

A simple and sensitive high performance liquid chromatography (HPLC) method was developed to determine residual Pluronic F-68 (PF-68) in in-process samples of monoclonal antibody (MAb) preparations. The method permits the direct injection of proteinaceous samples after simple sample dilution and is able to quantitate as low as 50 mg/L of PF-68 in the presence of up to approximately 30 g/L of protein. The PF-68 molecule was separated on a restricted access reversed phase column using a step gradient and then measured by an evaporative light scattering detector (ELSD). The method was successfully applied to demonstrate PF-68 clearance in MAb purification processes. A modified colorimetric method using liquid–liquid extraction and cobalt thiocyanate to derivatize PF-68 is also described. The results obtained by both the HPLC and colorimetric methods were compared. In addition to its ease of use and simplicity, the HPLC method had better accuracy and higher throughput than the colorimetric method.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Chromatography A - Volume 1218, Issue 15, 15 April 2011, Pages 2106–2113
نویسندگان
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