The assessment of the propensity of biotherapeutics to elicit undesirable immune responses in patients is an essential part of biological drug development. The immunogenicity of biotherapeutics can be investigated by immune cell proliferation, ADA production, cytokine release signatures as biomarkers of immune responses or complement activation.
IMMUNI T provides immunogenicity services by developing and applying methods commonly required in managing risk of biologics in safety and efficacy studies, in order to help you understand the issues and address the potential problems of drug immunogenicity:
Proliferation assays (3H-thymidine incorporation and/or dye labeling)
Cytokine production assays
ADA assays (detection and neutralization analysis)
In silico prediction
HSA: Human Serum Albumin (negative control)
Candida: Candida albicans (positive control)
TI: Biosimilar molecule
RI : Innovator molecule
Proliferation assay to compare the immunogenic potential of 4 biosimilar test items (TI) to 2 innovator reference items (RI) using 3H-thymidine incorporation as proliferation readout.
Freshly-isolated PBMCs were harvested from 56 donors of mixed ethnic origin and mixed gender.