title: Development of a Generic Anti-PEG Antibody Assay Using BioScale's Acoustic Membrane MicroParticle Technology.
abstract: Immunogenicity testing for PEGylated biotherapeutics should include methods to detect both anti-protein and anti-PEG antibodies (anti-PEG). Although some methods have been published for the detection of anti-PEG antibodies, the information is incomplete and, in some cases, reagents used (such as Tween-20) are known to interfere with detection. This rapid communication describes the use of BioScale's Acoustic Membrane MicroParticle (AMMP®) technology using the ViBE® Workstation to measure anti-PEG antibodies in human serum samples. Briefly, a sample spiked with monoclonal human IgG anti-PEG antibody is diluted in buffer and incubated with paramagnetic beads coated with linear chain mPEG to capture anti-PEG antibodies. The complex is then captured on an acoustic membrane coated with Protein A. The change in mass on the membrane caused by the binding of the complex to the membrane results in a signal proportional to the mass of anti-PEG antibodies. The data indicate that an assay with a sensitivity of less than 1000 ng/mL for IgG is achievable. This level of sensitivity is better than current published reports on IgG anti-PEG antibody detection.
authors.affiliation: Bioanalytical Sciences Biologics, Bristol-Myers Squibb, Princeton, New Jersey, 08543, USA. Huijin.dong@bms.com.
authors.forename: Huijin
authors.initials: H
authors.lastname: Dong
authors.affiliation: Bioanalytical Sciences Biologics, Bristol-Myers Squibb, Princeton, New Jersey, 08543, USA.
authors.forename: Johanna R
authors.initials: JR
authors.lastname: Mora
authors.affiliation: Bioanalytical Sciences Biologics, Bristol-Myers Squibb, Princeton, New Jersey, 08543, USA.
authors.forename: Catherine
authors.initials: C
authors.lastname: Brockus
authors.affiliation: Bioanalytical Sciences Biologics, Bristol-Myers Squibb, Princeton, New Jersey, 08543, USA.
authors.forename: Shannon D
authors.initials: SD
authors.lastname: Chilewski
authors.affiliation: Bioanalytical Sciences Biologics, Bristol-Myers Squibb, Princeton, New Jersey, 08543, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Dodge
authors.affiliation: BioScale, Billerica, Massachusetts, 01821, USA.
authors.forename: Colin
authors.initials: C
authors.lastname: Merrifield
authors.affiliation: BioScale, Billerica, Massachusetts, 01821, USA.
authors.forename: W Matthew
authors.initials: WM
authors.lastname: Dickerson
authors.affiliation: Bioanalytical Sciences Biologics, Bristol-Myers Squibb, Princeton, New Jersey, 08543, USA.
authors.forename: Binodh
authors.initials: B
authors.lastname: DeSilva
mesh_terms: D000888:Antibodies, Anti-Idiotypic / Q000097:blood*; D001710:Biotin / Q000097:blood; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood*; D011092:Polyethylene Glycols / Q000032:analysis*
chemical_list: D000888:Antibodies, Anti-Idiotypic; D007074:Immunoglobulin G; D011092:Polyethylene Glycols; D001710:Biotin
keywords: acoustic membrane microparticle technology; anti-peg antibodies; emerging technology; immunogenicity assays; pegylated biotherapeutics