کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
9901506 | 1545424 | 2005 | 11 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Induction and analysis of aggregates in a liquid IgG1-antibody formulation
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کلمات کلیدی
موضوعات مرتبط
علوم زیستی و بیوفناوری
بیوشیمی، ژنتیک و زیست شناسی مولکولی
بیوتکنولوژی یا زیستفناوری
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چکیده انگلیسی
Both mechanical stress methods can provoke aggregate formation. The method of stirring induces particles in the range of 10-25 μm comparable to shaking stress. However, stirred samples show a much higher absorbance and reveal a second particle species in DLS analysis, suggesting that stirring stress induces a higher amount of smaller protein aggregates. Addition of polysorbate 80 protects the antibody against aggregation. Only in stirred samples a slight increase in sub-visible particles and turbidity was noted. However, a greater extent of aggregation products was detected by DLS as compared to surfactant-free formulations. Thus, polysorbate 80 appears to stabilise small aggregates and prevents further proceeding of the aggregation process. The induction of aggregates by stirring stress in Reacti VialsTM analysed by absorbance measurement seems to be a good combination for high-throughput formulation studies.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: European Journal of Pharmaceutics and Biopharmaceutics - Volume 59, Issue 3, April 2005, Pages 407-417
Journal: European Journal of Pharmaceutics and Biopharmaceutics - Volume 59, Issue 3, April 2005, Pages 407-417
نویسندگان
Hanns-Christian Mahler, Robert Müller, Wolfgang Frieβ, Aurelie Delille, Susanne Matheus,