Large Molecule Quantification

Address the quantification of peptide- and protein-based biotherapeutics and biomarkers.

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An Intact Level Workflow for Sensitive Monoclonal Antibody Monitoring in Preclinical Matrix

This poster demonstrates HRMS sensitivity of intact level quantification for three monoclonal antibodies, adalimumab, infliximab, and trastuzumab prepared through affinity purification in mouse plasma.

Development of a SPE LC-MS/MS Method for the Bioanalytical Quantification of Salmon Calcitonin from Human Serum

This application note describes a simple sample preparation strategy using Oasis WCX μElution SPE combined with analytical flow LC and a tandem (triple) quadrupole MS for the high sensitivity quantification of salmon calcitonin from human serum.

Oasis Peptide Bioanalysis Reference Card

This reference card highlights bioanalytical sample preparation and method development for therapeutic and endogenous peptides.

High Resolution Mass Spectrometry for Quantitative and Qualitative (Quant/Qual) Bioanalysis of Antibody-based Therapeutics using Intact mAb and Subunit Detection

John T. Mehl, Ph.D Sr. Research Investigator, Bioanalytical Research Bristol-Myers Squibb

As antibody-based therapeutics become more common and more structurally complex, there is an increased need for more in depth understanding of the in vivo disposition of this class of drug modality. This presentation provides an overview of affinity sample preparation and highlight examples of how both Intact and subunit mAb bioanalysis provides insight into the in vivo disposition of antibody-based therapeutics.

Developing bioanalytical assays and workflows for peptide/protein biomarkers and biotherapeutics: Getting the right assay the first time

Matt Szapacs, Ph.D Group Leader Exploratory Biomarker Assay Group GlaxoSmithKline

In recent years the use of LC-MS technologies for the quantitation of peptide/protein biomarkers has increased dramatically. This presentation focuses on case studies highlighting the use of systematic method development strategies for both intact analysis and methods involving digestion. In addition, instrument selection (High resolution vs. QQQ) will be highlighted.

A Powerful Hybrid IA-LC-MS/MS Method for Routine Quantification of Insulin Analogues and their Biosimilars in Clinical Trial Samples

Michael Blackburn, M.Phil Bioanalytical Scientist, Method Development Specialist ARCINOVA

Mass spectrometry based assays are rapidly becoming the gold standard for the analysis of insulin biosimilars, and are increasingly requested by regulatory authorities during clinical trials for new diabetic therapies, due to their superior specificity. In this presentation, we show how the sensitivity of the Xevo TQ-XS combined with immunoaffinity extraction and UPLC enables bioanalysts to bring new compounds to market.

High Sensitivity Intact Monoclonal Antibody (mAb) HRMS Quantification

The complexity of trastuzumab, and biotherapeutic proteins in general, require a multifaceted and flexible approach for their characterization and quantification. Highly sensitive direct quantitation at the intact level was achieved using a Waters Vion IMS QTof and UNIFI.

Accurate and Sensitive LC-MS/MS Quantification of Adalimumab in Serum/Plasma: Impact of Sample Preparation on Method Performance

This application note describes the sensitive and selective quantification of adalimumab from serum/plasma using a kit-based approach for sample digestion and peptide level clean-up. Coupling different enrichment techniques to the standardized approach of ProteinWorks eXpress Digest and SPE Clean-up Kits provided substantial sensitivity benefit with the increased complexity of each technique.

Comparison of Tandem and High Resolution Mass Spectrometry for the Quantification of the Monoclonal Antibody, Trastuzumab in Plasma

This technology brief demonstrates the sensitive and robust HRMS quantification of trastuzumab from plasma.

Accurate Quantification of intact Insulin-like Growth Factor I (IGF-I) using High Resolution Mass Spectrometry (HRMS) for Clinical Research

This technology brief demonstrates analytically sensitive, accurate, and robust quantification of intact IGF-I in biological matrix using a simple sample preparation workflow, an analytical LC and HRMS.

HRMS platforms, with their ability to provide qualitative and quantitative information offer a flexible alternative to TQ systems, especially for direct quantification of intact proteins. With improvements in hardware and software, HRMS platforms can now achieve the performance characteristics required for bioanalytical quantification, as highlighted by the analytically sensitive (10 ng/mL) and robust (CV’s <10%) quantification of intact IGF-I for clinical research.