Immunogenicity of Subcutaneously Administered Therapeutic Proteins—a Mechanistic Perspective

• Published in: The AAPS journal Vol. 15; no. 4; pp. 897 - 900
• Main Authors: Fathallah, Anas M., Bankert, Richard B., Balu-Iyer, Sathy V.
• Format: Journal Article
• Language: English
• Published: Boston Springer US 01.10.2013
• Subjects: Animals; Antigen Presentation - drug effects; Antigen Presentation - physiology; Biochemistry; Biomedical and Life Sciences; Biomedicine; Biotechnology; Commentary; Humans; Immunogenetic Phenomena - drug effects; Immunogenetic Phenomena - physiology; Immunosuppressive Agents - administration & dosage; Immunosuppressive Agents - immunology; Immunosuppressive Agents - metabolism; Injections, Subcutaneous; Pharmacology/Toxicology; Pharmacy; Proto-Oncogene Proteins - administration & dosage; Proto-Oncogene Proteins - immunology; Proto-Oncogene Proteins - metabolism; Skin - drug effects; Skin - immunology; Skin - metabolism; biotechnology; mitigation of immunogenicity; protein therapeutics; immunogenicity; subcutaneous administration
• ISSN: 1550-7416; 1550-7416
• DOI: 10.1208/s12248-013-9510-6

The administration of therapeutic proteins via the subcutaneous route (sc) is desired for compliance and convenience, but could be challenging due to perceived immunogenic potential or unwanted immune responses. There are clinical and preclinical data supporting as well as refuting the generalized notion that sc is more immunogenic. We provide a mechanistic perspective of immunogenicity of therapeutic proteins administered via the sc route and discuss strategies and opportunities for novel therapeutic approaches to mitigate immunogenicity.