Application of a Plug-and-Play Immunogenicity Assay in Cynomolgus Monkey Serum for ADCs at Early Stages of Drug Development
Joint Authors
Carrasco-Triguero, Montserrat
Davis, Helen
Zhu, Yuda
Coleman, Daniel
Nazzal, Denise
Vu, Paul
Kaur, Surinder
Source
Journal of Immunology Research
Issue
Vol. 2016, Issue 2016 (31 Dec. 2016), pp.1-14, 14 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2016-03-22
Country of Publication
Egypt
No. of Pages
14
Main Subjects
Abstract EN
Immunogenicity assessment during early stages of nonclinical biotherapeutic development is not always warranted.
It is rarely predictive for clinical studies and evidence for the presence of anti-drug antibodies (ADAs) may be inferred from the pharmacokinetic (PK) profile.
However, collecting and banking samples during the course of the study are prudent for confirmation and a deeper understanding of the impact on PK and safety.
Biotherapeutic-specific ADA assays commonly developed can require considerable time and resources.
In addition, the ADA assay may not be ready when needed if the study of PK and safety data triggers assay development.
During early stages of drug development for antibody-drug conjugates (ADCs), there is the added complication of the potential inclusion of several molecular variants in a study, differing in the linker and/or drug components.
To simplify analysis of ADAs at this stage, we developed plug-and-play generic approaches for both the assay format and the data analysis steps.
Firstly, the assay format uses generic reagents to detect ADAs.
Secondly, we propose a cut point methodology based on animal specific baseline variability instead of a population data approach.
This assay showed good sensitivity, drug tolerance, and reproducibility across a variety of antibody-derived biotherapeutics without the need for optimization across molecules.
American Psychological Association (APA)
Carrasco-Triguero, Montserrat& Davis, Helen& Zhu, Yuda& Coleman, Daniel& Nazzal, Denise& Vu, Paul…[et al.]. 2016. Application of a Plug-and-Play Immunogenicity Assay in Cynomolgus Monkey Serum for ADCs at Early Stages of Drug Development. Journal of Immunology Research،Vol. 2016, no. 2016, pp.1-14.
https://search.emarefa.net/detail/BIM-1108738
Modern Language Association (MLA)
Carrasco-Triguero, Montserrat…[et al.]. Application of a Plug-and-Play Immunogenicity Assay in Cynomolgus Monkey Serum for ADCs at Early Stages of Drug Development. Journal of Immunology Research No. 2016 (2016), pp.1-14.
https://search.emarefa.net/detail/BIM-1108738
American Medical Association (AMA)
Carrasco-Triguero, Montserrat& Davis, Helen& Zhu, Yuda& Coleman, Daniel& Nazzal, Denise& Vu, Paul…[et al.]. Application of a Plug-and-Play Immunogenicity Assay in Cynomolgus Monkey Serum for ADCs at Early Stages of Drug Development. Journal of Immunology Research. 2016. Vol. 2016, no. 2016, pp.1-14.
https://search.emarefa.net/detail/BIM-1108738
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1108738