PEGylated & PEG Immunogenicity ELISA
Polyethylene glycol (PEG) is a widely used polymer in drug delivery systems and is often directly conjugated to a drug therapeutic to increase the retention time, reduce the immunogenicity and increase stability towards metabolic enzymes. Earlier it was reported that PEGylation is non-immunogenic but recently research has shown that PEG itself can be immunogenic.
The latest draft guidance on Biosimilars released by the FDA in February 2012 states that atleast two separate immunogenicity studies (pre & post monitoring) of biotherapeutics should be conducted to compare any biosimilar to its reference product. We offer sensitive immunogenicity kits for the quantitative detection of PEGylated molecules & a conventional double antigen bridging ELISA to detect anti-PEG antibodies or anti-drug antibodies to the various PEG polymers for immunogenicity testing.