Development of a validated novel bead extraction method for the detection of anti-PEG antibodies in human serum

Polyethylene glycol (PEG) is used in many applications including drug development. Due to exposure to environmental products, there is a high prevalence of preexisting anti-PEG antibodies in the global human population. The presence of anti-PEG antibodies is a concern for potentially reducing the efficacy of therapeutics after administration and represents a risk of safety events after exposure to PEGylated drug products. The authors detail the development and validation of a creative and sensitive method for the detection of anti-PEG antibodies. 

This method uses a novel approach to extract the anti-PEG antibodies from the serum sample, allowing a single sample to measure both anti-PEG and anti-drug antibodies, enabling a streamlined immunogenicity strategy for PEG-containing biotherapeutics.