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  • Title: Development and characterization of antibody reagents to assess anti-PEG IgG antibodies in clinical samples.
    Author: Krishna M, Palme H, Duo J, Lin Z, Corbett M, Dodge R, Piccoli S, Myler H, Pillutla R, Desilva B.
    Journal: Bioanalysis; 2015; 7(15):1869-83. PubMed ID: 26295988.
    Abstract:
    BACKGROUND: Polyethylene glycol (PEG) is a polymer that can be conjugated with therapeutic proteins. Monitoring anti-PEG antibodies in human subjects may be required as part of immunogenicity assessment. The lack of well-characterized anti-PEG reagents have limited our understanding of anti-PEG humoral response. RESULTS: Antibodies reactive to PEG were engineered with a human IgG1 Fc. Surface plasmon resonance and plate-based methods demonstrated that their binding was dependent on molecular weight (MW) of PEG. Specificity experiments using chemical analogs identified their specificity. CONCLUSION: Affinity, specificity and MW of PEG are critical characteristics that impact interactions of anti-PEG antibodies with PEG. These attributes especially MW of PEG and the assay formats may impact the ability to detect anti-PEG antibodies.
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