Approaches to Mitigate the Unwanted Immunogenicity of Therapeutic Proteins during Drug Development

• Published in: The AAPS journal Vol. 19; no. 2; pp. 377 - 385
• Main Authors: Salazar-Fontana, Laura I., Desai, Dharmesh D., Khan, Tarik A., Pillutla, Renuka C., Prior, Sandra, Ramakrishnan, Radha, Schneider, Jennifer, Joseph, Alexandra
• Format: Journal Article
• Language: English
• Published: New York Springer US 01.03.2017
• Subjects: Animals; Antibodies - immunology; Antibody Formation - immunology; Antigen-Presenting Cells - immunology; Biochemistry; Biomedical and Life Sciences; Biomedicine; Biotechnology; Disease Models, Animal; Drug Delivery Systems; Drug Design; Humans; Immunity, Innate - immunology; Immunologic Factors - administration & dosage; Immunologic Factors - adverse effects; Immunologic Factors - immunology; Mice; Pharmacology/Toxicology; Pharmacy; Proteins - administration & dosage; Proteins - adverse effects; Proteins - immunology; Review Article; T-Lymphocytes - immunology; Theme: Controlling Unwanted Immunogenicity to Biotherapeutics; anti-drug antibodies; immune mitigation; immune prediction; therapeutic proteins; tolerance

ABSTRACT All biotherapeutics have the potential to induce an immune response. This immunological response is complex and, in addition to antibody formation, involves T cell activation and innate immune responses that could contribute to adverse effects. Integrated immunogenicity data analysis is cru...