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Storage Conditions of Conjugated Reagents Can Impact Results of Immunogenicity Assays.
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.
Afiliación
  • Kubiak RJ; Drug Metabolism, Pharmacokinetics and Biological Safety Assessment, MedImmune LLC, One MedImmune Way, Gaithersburg, MD 20878, USA.
  • Lee N; Drug Metabolism, Pharmacokinetics and Biological Safety Assessment, MedImmune LLC, One MedImmune Way, Gaithersburg, MD 20878, USA.
  • Zhu Y; Drug Metabolism, Pharmacokinetics and Biological Safety Assessment, MedImmune LLC, One MedImmune Way, Gaithersburg, MD 20878, USA.
  • Franch WR; Analytical Biotechnology Sciences and Strategy, MedImmune LLC, One MedImmune Way, Gaithersburg, MD 20878, USA.
  • Levitskaya SV; Analytical Biotechnology Sciences and Strategy, MedImmune LLC, One MedImmune Way, Gaithersburg, MD 20878, USA.
  • Krishnan SR; Drug Metabolism, Pharmacokinetics and Biological Safety Assessment, MedImmune LLC, One MedImmune Way, Gaithersburg, MD 20878, USA.
  • Abraham V; Drug Metabolism, Pharmacokinetics and Biological Safety Assessment, MedImmune LLC, One MedImmune Way, Gaithersburg, MD 20878, USA.
  • Akufongwe PF; Drug Metabolism, Pharmacokinetics and Biological Safety Assessment, MedImmune LLC, One MedImmune Way, Gaithersburg, MD 20878, USA.
  • Larkin CJ; Analytical Biotechnology Sciences and Strategy, MedImmune LLC, One MedImmune Way, Gaithersburg, MD 20878, USA.
  • White WI; Drug Metabolism, Pharmacokinetics and Biological Safety Assessment, MedImmune LLC, One MedImmune Way, Gaithersburg, MD 20878, USA.
J Immunol Res ; 2016: 1485615, 2016.
Article en En | MEDLINE | ID: mdl-27478855
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Preservación Biológica / Inmunoensayo / Indicadores y Reactivos Tipo de estudio: Diagnostic_studies Límite: Humans Idioma: En Revista: J Immunol Res Año: 2016 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Egipto
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Preservación Biológica / Inmunoensayo / Indicadores y Reactivos Tipo de estudio: Diagnostic_studies Límite: Humans Idioma: En Revista: J Immunol Res Año: 2016 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Egipto