All biological therapeutics have the potential to induce an immune-mediated response ranging from benign to severe adverse effects. These effects can encompass diminished clinical efficacy of the biotherapeutic being administered due to hypersensitivity, allergic reactions, or even cytokine storms. Consequently, regulatory agencies are looking to understand the implications of immunogenicity and are directing the industry to integrate programs for immunogenicity risk management during the pre-clinical and clinical phases of drug development. Download this application note to see how ultrasensitive SMC® assays are helping researchers overcome the challenges of immunogenicity testing.
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