Refined analysis of antigen-specific antibody responses--a new one-step tool in immunogenicity studies.
Eur J Pharm Sci
; 44(3): 187-93, 2011 Oct 09.
Article
en En
| MEDLINE
| ID: mdl-21777676
ABSTRACT
Immunogenicity is a continuous efficacy and safety issue of biopharmaceuticals. Pre-clinical models for prediction of immunogenicity itself as well as biomarkers to reveal potential mechanisms behind an already existing antibody response are still needed. A sensitive, robust and specific immunogenicity assay has therefore been developed that can detect and measure antibodies of five classes against an administered recombinant human protein drug. Additionally, a validation was performed to evaluate the reproducibility and specificity of this newly developed assay. The production of drug-induced antibodies in mice injected with a recombinant human protein drug has been measured by using a modified version of a multi-parametric bead analysis technique. Competitive binding was used to verify drug-specificity of the antibodies. Results showed that the mouse response against the recombinant human protein was IgG1- and IgG2b-specific, suggesting that the drug-induced response was driven by both Th1/Th2 cells; a finding confirmed by measurement of the cytokine profile. With this assay, anti-drug antibody class and subclass screening may be executed in one step.
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Biofarmacia
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Inmunoglobulina G
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Inmunoensayo
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Drogas en Investigación
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Especificidad de Anticuerpos
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Antígenos
Tipo de estudio:
Diagnostic_studies
/
Prognostic_studies
Límite:
Animals
Idioma:
En
Revista:
Eur J Pharm Sci
Asunto de la revista:
FARMACIA
/
FARMACOLOGIA
/
QUIMICA
Año:
2011
Tipo del documento:
Article
País de afiliación:
Suecia