title: Development and characterization of antibody reagents to assess anti-PEG IgG antibodies in clinical samples.
abstract: BACKGROUND
  Polyethylene glycol (PEG) is a polymer that can be conjugated with therapeutic proteins. Monitoring anti-PEG antibodies in human subjects may be required as part of immunogenicity assessment. The lack of well-characterized anti-PEG reagents have limited our understanding of anti-PEG humoral response.
  
  
  RESULTS
  Antibodies reactive to PEG were engineered with a human IgG1 Fc. Surface plasmon resonance and plate-based methods demonstrated that their binding was dependent on molecular weight (MW) of PEG. Specificity experiments using chemical analogs identified their specificity.
  
  
  CONCLUSIONS
  Affinity, specificity and MW of PEG are critical characteristics that impact interactions of anti-PEG antibodies with PEG. These attributes especially MW of PEG and the assay formats may impact the ability to detect anti-PEG antibodies.
authors: Bristol-Myers Squibb Company, Rt 206 & Province Line Road, Princeton, NJ 08543, USA.
authors: Murli
authors: M
authors: Krishna
authors: Bristol-Myers Squibb Company, Rt 206 & Province Line Road, Princeton, NJ 08543, USA.
authors: Holly
authors: H
authors: Palme
authors: Bristol-Myers Squibb Company, Rt 206 & Province Line Road, Princeton, NJ 08543, USA.
authors: Jia
authors: J
authors: Duo
authors: Bristol-Myers Squibb Company, Rt 206 & Province Line Road, Princeton, NJ 08543, USA.
authors: Zheng
authors: Z
authors: Lin
authors: Bristol-Myers Squibb Company, Rt 206 & Province Line Road, Princeton, NJ 08543, USA.
authors: Martin
authors: M
authors: Corbett
authors: Bristol-Myers Squibb Company, Rt 206 & Province Line Road, Princeton, NJ 08543, USA.
authors: Robert
authors: R
authors: Dodge
authors: Bristol-Myers Squibb Company, Rt 206 & Province Line Road, Princeton, NJ 08543, USA.
authors: Steven
authors: S
authors: Piccoli
authors: Bristol-Myers Squibb Company, Rt 206 & Province Line Road, Princeton, NJ 08543, USA.
authors: Heather
authors: H
authors: Myler
authors: Bristol-Myers Squibb Company, Rt 206 & Province Line Road, Princeton, NJ 08543, USA.
authors: Renuka
authors: R
authors: Pillutla
authors: Bristol-Myers Squibb Company, Rt 206 & Province Line Road, Princeton, NJ 08543, USA.
authors: Binodh
authors: B
authors: Desilva
mesh_terms: D000818:Animals; D000888:Antibodies, Anti-Idiotypic / Q000737:chemistry*; D000917:Antibody Formation; D006801:Humans; D051379:Mice; D011092:Polyethylene Glycols / Q000737:chemistry*
chemical_list: D000888:Antibodies, Anti-Idiotypic; C048844:anti-IgG; D011092:Polyethylene Glycols