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Generic Anti-PEG Antibody Assay on ProterixBio's (Formerly BioScale) ViBE Platform Shows Poor Reproducibility.

Shannon D Chilewski¹, Julie Shields², Johanna R Mora³

¹Bioanalytical Sciences, Bristol-Myers Squibb, Princeton, New Jersey, USA. shannon.chilewski@bms.com.

The AAPS Journal

|April 26, 2018

Summary

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PEGylation enhances therapeutic protein half-life, but immunogenicity testing requires detecting anti-PEG antibodies. An acoustic membrane microparticle (AMMP) assay initially showed promise but proved too variable for clinical use.

Area of Science:

Biotechnology
Immunology
Pharmacology

Background:

PEGylation is a common protein modification to extend drug half-life.
Immunogenicity testing for PEGylated proteins requires detecting anti-protein and anti-PEG antibodies.
Acoustic membrane microparticle (AMMP) technology was previously explored for anti-PEG antibody detection.

Purpose of the Study:

To further validate an AMMP-based assay for detecting anti-PEG antibodies in human serum.
To assess the assay's suitability for supporting clinical sample analysis.

Main Methods:

Utilized ProterixBio's (formerly BioScale) acoustic membrane microparticle (AMMP) technology.
Performed additional experimentation to validate a previously reported anti-PEG antibody detection method.

Keywords:

PEGylated biotherapeutics acoustic membrane microparticle technology anti-PEG antibodies emerging technology immunogenicity assays

Related Experiment Videos

Analyzed assay reproducibility and sensitivity using human serum samples.

Main Results:

Initial method development demonstrated high sensitivity (1 μg/mL) and good reproducibility (CV < 7%).
Subsequent validation experiments revealed high variability (CV > 20%).
The assay was deemed unsuitable for supporting clinical sample analysis due to excessive variability.

Conclusions:

Despite initial promising results, the AMMP-based assay for anti-PEG antibodies exhibits high variability.
The assay's current performance makes it unsuitable for reliable clinical sample analysis.
Further optimization is required to improve the assay's reproducibility for clinical applications.