کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
2480976 | 1556228 | 2011 | 7 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Refined analysis of antigen-specific antibody responses - A new one-step tool in immunogenicity studies
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کلمات کلیدی
FDAPBSHABAEMEAAPCBSA - BSAbovine serum albumin - آلبومین سرم گاوantibodies - آنتی بادی هاAntigen presenting cells - آنتیژن ارائه سلولenzyme linked immunosorbent assay - آنزیم تست ایمونوسیورسانس مرتبط استEuropean Medicines agency - آژانس دارویی اروپاstandard deviation - انحراف معیارImmunogenicity - ایمنی زاییimmunoglobulin - ایمونوگلوبولینbiopharmaceuticals - بیوفرم داروهاELISA - تست الیزاRoom temperature - دمای اتاقCV% - رزومه٪Food and Drug Administration - سازمان غذا و داروFluorescence intensity - شدت فلورسانسconfidence interval - فاصله اطمینانphycoerythrin - فایکوئیریدینPhosphate buffered saline - فسفات بافر شورLuminex - لومینکسMHC - مجموعه سازگاری بافتی اصلیmajor histocompatibility complex - مجموعه سازگاری بافتی اصلیquality control - کنترل کیفیت
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
پیش نمایش صفحه اول مقاله
چکیده انگلیسی
Immunogenicity is a continuous efficacy and safety issue of biopharmaceuticals. Pre-clinical models for prediction of immunogenicity itself as well as biomarkers to reveal potential mechanisms behind an already existing antibody response are still needed. A sensitive, robust and specific immunogenicity assay has therefore been developed that can detect and measure antibodies of five classes against an administered recombinant human protein drug. Additionally, a validation was performed to evaluate the reproducibility and specificity of this newly developed assay. The production of drug-induced antibodies in mice injected with a recombinant human protein drug has been measured by using a modified version of a multi-parametric bead analysis technique. Competitive binding was used to verify drug-specificity of the antibodies. Results showed that the mouse response against the recombinant human protein was IgG1- and IgG2b-specific, suggesting that the drug-induced response was driven by both Th1/Th2 cells; a finding confirmed by measurement of the cytokine profile. With this assay, anti-drug antibody class and subclass screening may be executed in one step.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: European Journal of Pharmaceutical Sciences - Volume 44, Issue 3, 9 October 2011, Pages 187-193
Journal: European Journal of Pharmaceutical Sciences - Volume 44, Issue 3, 9 October 2011, Pages 187-193
نویسندگان
Britta Granath, Jan Holgersson, Nina Brenden,