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Your search keyword '"Non-cell-based assays"' showing total 2 results
Start Over Descriptor "Non-cell-based assays" Topic interferon-beta
2 results on '"Non-cell-based assays"'

1. Development and characterization of a non-cell-based assay to assess the presence of neutralizing antibodies to interferon-beta in clinical samples.

Author

Cludts I, Meager A, Thorpe R, and Wadhwa M

Subjects
Cohort Studies, HEK293 Cells, Humans, Interferon beta-1a, Interferon-beta antagonists & inhibitors, Interferon-beta therapeutic use, Multiple Sclerosis, Relapsing-Remitting immunology, Multiple Sclerosis, Relapsing-Remitting therapy, Neutralization Tests methods, Recombinant Proteins antagonists & inhibitors, Recombinant Proteins immunology, Recombinant Proteins therapeutic use, Antibodies, Neutralizing blood, Immunoassay methods, Interferon-beta immunology, Luminescent Measurements methods
Abstract

Assessment of immunogenicity is an integral part of product development and involves evaluation of binding and neutralizing antibodies. The use of cell-based assays for detection of neutralizing antibodies (NAbs) is usually a regulatory expectation. Different cell-based assay formats are available for detection of anti-interferon-beta (IFN-β) NAbs but all present technical difficulties and limitations. In this paper, a non-cell-based NAb assay which overcomes the limitations of cell-based assays is described. This NAb assay utilizes an electrochemiluminescence detection platform and is based on the first step involved in all IFN-β-induced biological activities, namely the binding of IFN-β to its receptor, which is inhibited when NAbs are present. Using this approach, NAb titers in clinical samples from multiple sclerosis patients treated with IFN-β were determined and compared with those obtained using existing cell-based NAb assays. The sensitivity of the assays was not comparable, the cell-based approach having superior sensitivity. However a good correlation between the two approaches was observed. This study illustrates the practicality and feasibility of non-cell-based neutralization assays in the context of immunogenicity, however the utility of this approach would need to be assessed on a case-by-case basis for each therapeutic., (© 2013.)

Published
2013
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2. Development and characterization of a non-cell-based assay to assess the presence of neutralizing antibodies to interferon-beta in clinical samples

Author

Meenu Wadhwa, Robin Thorpe, Isabelle Cludts, and Anthony Meager

Subjects
Immunology, Cell, Context (language use), Biology, Non-cell-based assays, Neutralizing antibodies, Neutralization, Cohort Studies, Multiple Sclerosis, Relapsing-Remitting, Neutralization Tests, medicine, Immunology and Allergy, Humans, Receptor, Electrochemiluminescence, Immunoassay, Reporter gene, Immunogenicity, Interferon-beta, Interferon beta, Virology, Antibodies, Neutralizing, Recombinant Proteins, Titer, medicine.anatomical_structure, HEK293 Cells, Luminescent Measurements, biology.protein, Antibody, Interferon beta-1a
Abstract

Assessment of immunogenicity is an integral part of product development and involves evaluation of binding and neutralizing antibodies. The use of cell-based assays for detection of neutralizing antibodies (NAbs) is usually a regulatory expectation. Different cell-based assay formats are available for detection of anti-interferon-beta (IFN-β) NAbs but all present technical difficulties and limitations. In this paper, a non-cell-based NAb assay which overcomes the limitations of cell-based assays is described. This NAb assay utilizes an electrochemiluminescence detection platform and is based on the first step involved in all IFN-β-induced biological activities, namely the binding of IFN-β to its receptor, which is inhibited when NAbs are present. Using this approach, NAb titers in clinical samples from multiple sclerosis patients treated with IFN-β were determined and compared with those obtained using existing cell-based NAb assays. The sensitivity of the assays was not comparable, the cell-based approach having superior sensitivity. However a good correlation between the two approaches was observed. This study illustrates the practicality and feasibility of non-cell-based neutralization assays in the context of immunogenicity, however the utility of this approach would need to be assessed on a case-by-case basis for each therapeutic.

Published
2013

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