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Complex immune responses elicited upon treatment with biotherapeutic drugs are now revolutionizing the field of immuno-oncology. However, unwanted immune responses exerted by biologics can result in severe adverse effects. Immunogenicity testing at the early phase of drug development therefore can play a crucial role to avoid possible clinical consequences of anti-drug antibody (ADA) responses. Testing unwanted immune responses during drug development is becoming increasingly important for pharmaceutical industries and regulatory agencies like the FDA and EMEA.
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