کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
9754404 | 1494678 | 2005 | 12 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Validation of immunoassays used to assess immunogenicity to therapeutic monoclonal antibodies
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کلمات کلیدی
موضوعات مرتبط
مهندسی و علوم پایه
شیمی
شیمی آنالیزی یا شیمی تجزیه
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چکیده انگلیسی
Immunogenicity has always been an important consideration in the evaluation of pharmaceutical protein biologics. In this article, method validation parameters relevant to enzyme immunoassays are described for assays applied to the analysis of anti-drug antibodies, with special considerations for immunogenicity to therapeutic monoclonal antibodies. Common strategies for experimental investigation of various validation parameters are proposed. In addition, a novel, yet simple, approach is proposed to categorize the validation effort into two mutually interdependent phases, based on the characterization of validation parameters as “system descriptive” or “system controlled”. System descriptive parameters are those that must be characterized but need not have pre-specified acceptance criteria for assay validation. In contrast, system-controlled parameters should be understood early in assay development, and optimized and confirmed using a priori acceptance criteria in validation to assure sufficient control over them during routine bioanalysis. This approach not only streamlines the validation process but also eliminates unnecessary redundancies. This validation method can be achieved with proper scientific rigor and remain within the realm of GLP compliance. The authors hope that other research groups would engage in discussions on validation of anti-drug antibody assays in order to establish a consistent approach across the industry and academia.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 39, Issues 3â4, 15 September 2005, Pages 364-375
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 39, Issues 3â4, 15 September 2005, Pages 364-375
نویسندگان
Dong Geng, Gopi Shankar, Allen Schantz, Manoj Rajadhyaksha, Hugh Davis, Carrie Wagner,