Universität zu Köln

Ingenhoven, Kathleen, Kramer, Daniel, Jensen, Poul Erik, Hermanrud, Christina, Ryner, Malin, Deisenhammers, Florian, Pallardy, Marc, Menge, Til, Hartung, Hans-Peter, Kieseieri, Bernd C., Bertotti, Elisa, Creeke, Paul, Fogdell-Hahn, Anna ORCID: 0000-0002-0311-9184 and Warnke, Clemens (2017). Development and Validation of an Enzyme-Linked Immunosorbent Assay for the Detection of Binding Anti-Drug Antibodies against Interferon Beta. Front. Neurol., 8. LAUSANNE: FRONTIERS MEDIA SA. ISSN 1664-2295

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Abstract

Objective: To develop and validate a method for the detection of binding anti-drug antibodies (ADAs) against interferon beta (IFN-beta) in human serum as part of a European initiative (ABIRISK) aimed at the prediction and analysis of clinical relevance of anti-biopharmaceutical immunization to minimize the risk. Method: A two-tiered bridging enzyme-linked immunosorbent assay (ELISA) format was selected and validated according to current recommendations. Screening assay: ADA in serum samples form complexes with immobilized IFN-beta and biotinylated IFN-beta, which are then detected using HRP labeled Streptavidin and TMB substrate. Confirrnation assay: Screen putative positive samples are tested in the presence of excess drug (preincubation of sera with 0.3 mu g/mL of soluble IFN-beta) and percentage of inhibition is calculated. Results: The assay is precise, and the sensitivity of the assay was confirmed to be 26 ng/mL using commercially available polyclonal rabbit antihuman IFN-beta in human sera as the positive control. Conclusion: An ultrasensitive ELISA for IFN-beta-binding ADA testing has been validated. This will form the basis to assess anti-biopharmaceutical immunization toward IFN-beta with regards to its clinical relevance and may allow for the development of predictive tools, key aims within the ABIRISK consortium.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Ingenhoven, Kathleen UNSPECIFIED UNSPECIFIED UNSPECIFIED Kramer, Daniel UNSPECIFIED UNSPECIFIED UNSPECIFIED Jensen, Poul Erik UNSPECIFIED UNSPECIFIED UNSPECIFIED Hermanrud, Christina UNSPECIFIED UNSPECIFIED UNSPECIFIED Ryner, Malin UNSPECIFIED UNSPECIFIED UNSPECIFIED Deisenhammers, Florian UNSPECIFIED UNSPECIFIED UNSPECIFIED Pallardy, Marc UNSPECIFIED UNSPECIFIED UNSPECIFIED Menge, Til UNSPECIFIED UNSPECIFIED UNSPECIFIED Hartung, Hans-Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Kieseieri, Bernd C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bertotti, Elisa UNSPECIFIED UNSPECIFIED UNSPECIFIED Creeke, Paul UNSPECIFIED UNSPECIFIED UNSPECIFIED Fogdell-Hahn, Anna UNSPECIFIED orcid.org/0000-0002-0311-9184 UNSPECIFIED Warnke, Clemens UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-225098
DOI:	10.3389/fneur.2017.00305
Journal or Publication Title:	Front. Neurol.
Volume:	8
Date:	2017
Publisher:	FRONTIERS MEDIA SA
Place of Publication:	LAUSANNE
ISSN:	1664-2295
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language NEUTRALIZING ANTIBODIES; IMMUNE-RESPONSES; HOST ANTIBODIES; MS-PATIENTS; RECOMMENDATIONS; THERAPY; IMMUNOGENICITY; OPTIMIZATION; DESIGN Multiple languages Clinical Neurology; Neurosciences Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/22509