Assay concept for detecting anti-drug IgM in human serum samples by using a novel recombinant human IgM positive control

Assay concept for detecting anti-drug IgM in human serum samples by using a novel recombinant human IgM positive control

Aim: Development and qualification of an easy-to-use ELISA for detection of IgM anti-drug antibodies (ADA) and its use in a clinical Phase I trial. Results & methodology: During the assay development two positive control (PC) approaches, the preparation of a chemically conjugated and a recombina...

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Bibliographic Details
Main Authors:	Abdolzade-Bavil, A. (Author), Engel, A.M (Author), Künzel, C. (Author), Pleitner, M. (Author), Schick, E. (Author), Stubenrauch, K. (Author)
Format:	Article
Language:	English
Published:	Future Medicine Ltd. 2021
Subjects:	ADA isotyping Antibodies, Anti-Idiotypic antibody detection antiidiotypic antibody anti-IgM Article biological therapy Biological Therapy biotherapeutics blood blood sampling conjugation controlled study drug antibody enzyme linked immunosorbent assay Enzyme-Linked Immunosorbent Assay HEK293 cell line human human cell Humans IgM positive control immune response immune response characterization immunocytokine immunogenicity immunoglobulin E immunoglobulin G1 immunoglobulin G3 immunoglobulin G4 immunoglobulin M malignant neoplasm measurement accuracy phase 1 clinical trial (topic) polymerase chain reaction practice guideline procedures qualitative analysis sensitivity and specificity signal transduction targeted immunocytokine
Online Access:	View Fulltext in Publisher

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