The AAPS Journal

, Volume 15, Issue 4, pp 897–900

Immunogenicity of Subcutaneously Administered Therapeutic Proteins—a Mechanistic Perspective


  • Anas M. Fathallah
    • Department of Pharmaceutical SciencesSUNY—University at Buffalo
  • Richard B. Bankert
    • Department of Immunology and MicrobiologySUNY—University at Buffalo
    • Department of Pharmaceutical SciencesSUNY—University at Buffalo

DOI: 10.1208/s12248-013-9510-6

Cite this article as:
Fathallah, A.M., Bankert, R.B. & Balu-Iyer, S.V. AAPS J (2013) 15: 897. 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.


biotechnologyimmunogenicitymitigation of immunogenicityprotein therapeuticssubcutaneous administration

Copyright information

© American Association of Pharmaceutical Scientists 2013