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• W2903846128 abstract "Pritumumab, a natural human IgG1kappa mAb, was isolated from the regional lymph node of a patient with cervical cancer. This antibody has been reported to bind the cytoskeletal protein vimentin, and to cell surface expressed vimentin referred to as ecto-domain vimentin (EDV). Here, we report details of the development of a potency of binding assay for pritumumab as a prerequisite before pursuing clinical trials. The enzyme linked immunosorbent assay (ELISA) to detect antibody-binding antigen can serve as a potency assay for release of manufactured samples to be used in clinical studies. Several layers of controls for this assay along with suitability testing for reagents and components of the assay must be developed before the assay can be incorporated for stability testing and release of manufatured samples." @default.
• W2903846128 created "2018-12-22" @default.
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• W2903846128 creator A5063863193 @default.
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• W2903846128 date "2018-12-12" @default.
• W2903846128 modified "2023-09-29" @default.
• W2903846128 title "A Binding Potency Assay for Pritumumab and Ecto-Domain Vimentin" @default.
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• W2903846128 doi "https://doi.org/10.1007/978-1-4939-8958-4_19" @default.
• W2903846128 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/30539482" @default.
• W2903846128 hasPublicationYear "2018" @default.
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