Stelara IL-12 Neutralisation Bioassays

Bioassays provide the means to directly assess the fundamental biological activity of Stelara, and as such signify a key component of a product characterization study.  Our extensive experience in the development of bioassays for the assessment of a wide range of monoclonal antibody products has allowed us to qualify a cell-based assay to measure the neutralization activity of Stelara and ustekinumab biosimilar products for use in clone selection, process development and similarity studies.  The neutralization potential of the test sample is measured and its potency reported relative to a reference standard.