Danika Wullner

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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 known clinical immunogenicity [FPX1 and FPX2] were assessed for(More)
BACKGROUND Specificity and sensitivity are essential in assays for immunogenicity assessment of biotherapeutics. Nonspecific interactions from excess therapeutic or anti-therapeutic antibody, soluble ligands (e.g., target receptor), or serum proteins associated with autoimmune conditions (e.g., rheumatoid factor) in samples can impact the detection of a(More)
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