Measurement of Pre-Existing IgG and IgM Antibodies against Polyethylene Glycol in Healthy Individuals

Bing Mae Chen, Yu Cheng Su, Chia Jung Chang, Pierre Alain Burnouf, Kuo-Hsiang Chuang, Chien Hsiun Chen, Tian Lu Cheng, Yuan Tsong Chen, Jer Yuarn Wu, Steve R. Roffler

研究成果: 雜誌貢獻文章同行評審

125 引文 斯高帕斯(Scopus)


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.
頁(從 - 到)10661-10666
期刊Analytical Chemistry
出版狀態已發佈 - 11月 1 2016

ASJC Scopus subject areas

  • 分析化學


深入研究「Measurement of Pre-Existing IgG and IgM Antibodies against Polyethylene Glycol in Healthy Individuals」主題。共同形成了獨特的指紋。