Evaluation of Acoustic Membrane Microparticle (AMMP) Technology for a Sensitive Ligand Binding Assay to Support Pharmacokinetic Determinations of a Biotherapeutic

Chilewski, Shannon D; Dickerson, W. Matthew; Mora, Johanna; Saab, Ashley; Alderman, Edward M.

doi:10.1208/s12248-014-9659-7

Cited by 6 publications

(2 citation statements)

References 6 publications

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“…In this assay, a magnetic bead conjugated with biotin PEG and bound anti-PEG antibody is detected on a Protein A functionalized sensor. The change in mass due to the bound complex changes the frequency of an oscillating piezoelectric membrane proportional to the amount of analyte bound [ 46 ]. The AMMP assay overcomes the issue of high background seen in other anti-PEG antibody assays as only beads that have the complex of PEG-anti-PEG antibody stick to the sensor.…”

Section: Generic Ada Assay Methodologiesmentioning

confidence: 99%

Emerging Technologies and Generic Assays for the Detection of Anti-Drug Antibodies

Partridge

Purushothama

Elango

et al. 2016

Journal of Immunology Research

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Anti-drug antibodies induced by biologic therapeutics often impact drug pharmacokinetics, pharmacodynamics response, clinical efficacy, and patient safety. It is critical to assess the immunogenicity risk of potential biotherapeutics in producing neutralizing and nonneutralizing anti-drug antibodies, especially in clinical phases of drug development. Different assay methodologies have been used to detect all anti-drug antibodies, including ELISA, radioimmunoassay, surface plasmon resonance, and electrochemiluminescence-based technologies. The most commonly used method is a bridging assay, performed in an ELISA or on the Meso Scale Discovery platform. In this report, we aim to review the emerging new assay technologies that can complement or address challenges associated with the bridging assay format in screening and confirmation of ADAs. We also summarize generic anti-drug antibody assays that do not require drug-specific reagents for nonclinical studies. These generic assays significantly reduce assay development efforts and, therefore, shorten the assay readiness timeline.

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Section: Generic Ada Assay Methodologiesmentioning

confidence: 99%

Emerging Technologies and Generic Assays for the Detection of Anti-Drug Antibodies

Partridge

Purushothama

Elango

et al. 2016

Journal of Immunology Research

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“…The Acoustic Membrane MicroParticle platform is an emerging technology that utilizes a non-optical detection system to determine analyte concentration by measuring the change in the oscillating frequency of a piezoelectric membrane (10). This rapid communication describes a method in which human serum spiked with monoclonal chimeric IgG is diluted in buffer and incubated with paramagnetic beads coated with either PEGylated therapeutic protein or biotinylated PEG to capture anti-PEG antibodies.…”

Section: Introductionmentioning

confidence: 99%

Development of a Generic Anti-PEG Antibody Assay Using BioScale’s Acoustic Membrane MicroParticle Technology

Dong

Mora

Brockus

et al. 2015

AAPS J

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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.

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Ligand Binding Assays in the Regulated Bioanalytical Laboratory

Mora

Hottenstein

DeSilva

2017

AAPS Advances in the Pharmaceutical Sciences Series

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Evaluation of Acoustic Membrane Microparticle (AMMP) Technology for a Sensitive Ligand Binding Assay to Support Pharmacokinetic Determinations of a Biotherapeutic

Cited by 6 publications

References 6 publications

Emerging Technologies and Generic Assays for the Detection of Anti-Drug Antibodies

Emerging Technologies and Generic Assays for the Detection of Anti-Drug Antibodies

Development of a Generic Anti-PEG Antibody Assay Using BioScale’s Acoustic Membrane MicroParticle Technology

Ligand Binding Assays in the Regulated Bioanalytical Laboratory

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