Immunogenicity is the ability of a foreign substance, such as a drug or vaccine, to provoke an immune response.
In this chapter, Certara Associate Director of Clinical Pharmacology, Morena Shaw discusses considerations when determining immunogenicity for complex biologics including monoclonal antibodies and antibody drug conjugates.
Certara accelerates medicines to patients using proprietary biosimulation software and technology to transform traditional drug discovery and development. Its clients include 1,600 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries.
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