Journal
JOURNAL OF PHARMACEUTICAL SCIENCES
Volume 108, Issue 5, Pages 1637-1654Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.xphs.2018.12.014
Keywords
immunogenicity; protein(s); antibody(s); immune response(s); immunology; pharmacokinetics; pharmacodynamics
Funding
- National Institutes of Health [HL-70227]
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Protein therapeutics have drastically changed the landscape of treatment for many diseases by providing a regimen that is highly specific and lacks many off-target toxicities. The clinical utility of many therapeutic proteins has been undermined by the potential development of unwanted immune responses against the protein, limiting their efficacy and negatively impacting its safety profile. This review attempts to provide an overview of immunogenicity of therapeutic proteins, including immune mechanisms and factors influencing immunogenicity, impact of immunogenicity, preclinical screening methods, and strategies to mitigate immunogenicity. (c) 2019 American Pharmacists Association (R). Published by Elsevier Inc. All rights reserved.
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