Storage Conditions of Conjugated Reagents Can Impact Results of Immunogenicity Assays
Joint Authors
Kubiak, Robert J.
Lee, Nancy
Zhu, Yuan
Franch, William R.
Levitskaya, Sophia V.
Krishnan, Surekha R.
Abraham, Varghese
Akufongwe, Peter F.
Larkin, Christopher J.
White, Wendy I.
Source
Journal of Immunology Research
Issue
Vol. 2016, Issue 2016 (31 Dec. 2016), pp.1-10, 10 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2016-07-10
Country of Publication
Egypt
No. of Pages
10
Main Subjects
Abstract EN
Consistent performance of anti-drug antibody (ADA) assays through all stages of clinical development is critical for the assessment of immunogenicity and interpretation of PK, PD, safety, and efficacy.
The electrochemiluminescent assays commonly employed for ADA measurement use drug conjugated with ruthenium and biotin to bind ADA in samples.
Here we report an association between high nonspecific ADA responses in certain drug-naïve individuals and the storage buffer of the conjugated reagents used in a monoclonal antibody ADA assay.
Ruthenylated reagents stored in phosphate-buffered saline (PBS) buffer had increased levels of aggregate and produced variable and high baseline responses in some subjects.
Reagents stored in a histidine-sucrose buffer (HSB) had lower aggregate levels and produced low sample responses.
In contrast to PBS, conjugated reagents formulated in HSB remained low in aggregate content and in sample response variability after 5 freeze/thaw cycles.
A reagent monitoring control (RMC) serum was prepared for the real-time evaluation of conjugated reagent quality.
Using appropriate buffers for storage of conjugated reagents together with RMCs capable of monitoring of reagent aggregation status can help ensure consistent, long-term performance of ADA methods.
American Psychological Association (APA)
Kubiak, Robert J.& Lee, Nancy& Zhu, Yuan& Franch, William R.& Levitskaya, Sophia V.& Krishnan, Surekha R.…[et al.]. 2016. Storage Conditions of Conjugated Reagents Can Impact Results of Immunogenicity Assays. Journal of Immunology Research،Vol. 2016, no. 2016, pp.1-10.
https://search.emarefa.net/detail/BIM-1108715
Modern Language Association (MLA)
Kubiak, Robert J.…[et al.]. Storage Conditions of Conjugated Reagents Can Impact Results of Immunogenicity Assays. Journal of Immunology Research No. 2016 (2016), pp.1-10.
https://search.emarefa.net/detail/BIM-1108715
American Medical Association (AMA)
Kubiak, Robert J.& Lee, Nancy& Zhu, Yuan& Franch, William R.& Levitskaya, Sophia V.& Krishnan, Surekha R.…[et al.]. Storage Conditions of Conjugated Reagents Can Impact Results of Immunogenicity Assays. Journal of Immunology Research. 2016. Vol. 2016, no. 2016, pp.1-10.
https://search.emarefa.net/detail/BIM-1108715
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1108715