@article{3468019c43d04fe0a59359b583c943df,
title = "Measurement of Pre-Existing IgG and IgM Antibodies against Polyethylene Glycol in Healthy Individuals",
abstract = "Polyethylene glycol (PEG) is a biocompatible polymer that is often attached to therapeutic molecules to improve bioavailability and therapeutic efficacy. Although antibodies with specificity for PEG may compromise the safety and effectiveness of PEGylated medicines, the prevalence of pre-existing anti-PEG antibodies in healthy individuals is unclear. Chimeric human anti-PEG antibody standards were created to accurately measure anti-PEG IgM and IgG antibodies by direct ELISA with confirmation by a competition assay in the plasma of 1504 healthy Han Chinese donors residing in Taiwan. Anti-PEG antibodies were detected in 44.3% of healthy donors with a high prevalence of both anti-PEG IgM (27.1%) and anti-PEG IgG (25.7%). Anti-PEG IgM and IgG antibodies were significantly more common in females as compared to males (32.0% vs 22.2% for IgM, p < 0.0001 and 28.3% vs 23.0% for IgG, p = 0.018). The prevalence of anti-PEG IgG antibodies was higher in younger (up to 60% for 20 year olds) as opposed to older (20% for >50 years) male and female donors. Anti-PEG IgG concentrations were negatively associated with donor age in both females (p = 0.0073) and males (p = 0.026). Both anti-PEG IgM and IgG strongly bound PEGylated medicines. The described assay can assist in the elucidation of the impact of anti-PEG antibodies on the safety and therapeutic efficacy of PEGylated medicines.",
author = "Chen, {Bing Mae} and Su, {Yu Cheng} and Chang, {Chia Jung} and Burnouf, {Pierre Alain} and Kuo-Hsiang Chuang and Chen, {Chien Hsiun} and Cheng, {Tian Lu} and Chen, {Yuan Tsong} and Wu, {Jer Yuarn} and Roffler, {Steve R.}",
note = "Funding Information: This work was supported by intramural funding from Academia Sinica and a grant from the Academia Sinica Research Program on Nanoscience and Nanotechnology. We thank the Proteomics Core Facility of the Institute of Biomedical Sciences, Academia Sinica, for MALDI-TOF measurements. We appreciate the technical help of Ms. Show-Ling Yang and Mr. Talal Qaisi. Lentivirus vectors were provided by the National RNAi Core Facility, Institute of Molecular Biology/Genomic Research Center, at Academia Sinica, Taipei, Taiwan. We gratefully acknowledge the members of the Translational Resource Center (Grant NSC102-2325-B-001-023) of the National Research Program for Biopharmaceuticals and the National Center for Genome Medicine (Grant NSC102-2319-B-001-001) of the National Core Facility Program for Biotechnology, National Science Council, at Academia Sinica, for their support in project management, subject recruitment, data coordination, genotyping performance, and statistical analysis. Publisher Copyright: {\textcopyright} 2016 American Chemical Society.",
year = "2016",
month = nov,
day = "1",
doi = "10.1021/acs.analchem.6b03109",
language = "English",
volume = "88",
pages = "10661--10666",
journal = "Analytical Chemistry",
issn = "0003-2700",
publisher = "American Chemical Society",
number = "21",
}