Factors that contribute to the immmunogenicity of therapeutic recombinant human proteins

Use of recombinant human proteins has revolutionized medicine by providing over 200 highly purified hormones and proteins that effectively treat many inherited and acquired peptide hormone and protein deficiencies. With the exception of therapeutic monoclonal antibodies, these biological medicines a...

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Bibliographic Details
Published inThrombosis and haemostasis Vol. 99; no. 5; p. 874
Main Authors Mukovozov, Ilya, Sabljic, Thomas, Hortelano, Gonzalo, Ofosu, Frederick A
Format Journal Article
LanguageEnglish
Published Germany 01.05.2008
Subjects
Animals
Antibodies - metabolism
Antibody Formation
Chemistry, Pharmaceutical
Cloning, Molecular
Dosage Forms
Drug Administration Routes
Drug Contamination
Drug Stability
Drug Storage
Humans
Polyethylene Glycols - chemistry
Protein Processing, Post-Translational
Recombinant Fusion Proteins - administration & dosage
Recombinant Fusion Proteins - biosynthesis
Recombinant Fusion Proteins - chemistry
Recombinant Fusion Proteins - immunology
Recombinant Fusion Proteins - therapeutic use
T-Lymphocytes - immunology
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Summary:Use of recombinant human proteins has revolutionized medicine by providing over 200 highly purified hormones and proteins that effectively treat many inherited and acquired peptide hormone and protein deficiencies. With the exception of therapeutic monoclonal antibodies, these biological medicines are synthesized by cultured cells using DNA sequences that would yield proteins with identical amino acid sequences as endogenous human proteins. Therefore, there was the broad expectation that recombinant human biological medicines would be non-immunogenic in patients capable of synthesizing even sub-optimal levels of these therapeutic proteins to which they are innately tolerant. However, the widespread clinical use of recombinant human proteins has demonstrated that nearly all of them are immunogenic. This observation suggests that factors additional to differences in amino acid sequences of endogenous and biotherapeutic proteins contribute to the immunogenicity of therapeutic proteins. The main aim of this review is to summarize some of the factors that are known to contribute to the immunogenicity of recombinant therapeutic proteins.
ISSN:0340-6245
DOI:10.1160/TH07-11-0654