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

ABSTRACT:

Aims

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. We developed and validated a creative and sensitive method for the detection of anti-PEG antibodies in human serum to support clinical programs for PEGylated drugs.

Methods

In this method, biotin-PEG streptavidin beads were used to extract anti-PEG antibodies from human serum for analysis in an anti-PEG ELISA assay. The same serum sample was analyzed i

SUBMITTER: Williams WT 

PROVIDER: S-EPMC11749383 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature