Considerations for optimization and validation of an in vitro PBMC derived T cell assay for immunogenicity prediction of biotherapeutics

Abstract An immune response to a biotherapeutic can be induced when the therapeutic is processed and presented by antigen presenting cell to T helper cells. This study evaluates the performance of an in vitro assay that can elicit antigen specific effector T cell responses. Two biotherapeutics with...

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Veröffentlicht in:	Clinical immunology (Orlando, Fla.) Fla.), 2010-10, Vol.137 (1), p.5-14
Hauptverfasser:	Wullner, Danika, Zhou, Lei, Bramhall, Erica, Kuck, Andrew, Goletz, Theresa J, Swanson, Steven, Chirmule, Narendra, Jawa, Vibha
Format:	Artikel
Sprache:	eng
Schlagworte:	Allergy and Immunology Amino acids Antibodies - immunology Antibodies - pharmacology Antibodies, Monoclonal - immunology Antibody Formation - immunology Biological and medical sciences Biological Therapy - adverse effects Biotherapeutics Cell Culture Techniques Cell Survival Cells, Cultured ELISPOT Fundamental and applied biological sciences. Psychology Fundamental immunology HLA-DR Antigens - immunology Humans Immunoassay - methods Immunogenicity prediction Immunoglobulin Fc Fragments - genetics Immunophenotyping Interferon-gamma - analysis Interferon-gamma - metabolism Leukocytes, Mononuclear - immunology Leukocytes, Mononuclear - metabolism Lymphocyte Activation - drug effects Lymphocyte Activation - immunology Lymphocyte Subsets - cytology Memory T cells PBMC Peptide Fragments - immunology Peptides - genetics Peptides - immunology Phytohemagglutinins - pharmacology Recombinant Proteins - immunology Recombinant Proteins - therapeutic use Reproducibility of Results T-Lymphocytes - immunology T-Lymphocytes - metabolism
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