Large Molecule Quantification

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

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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.

Development of a Workflow for the Metabolite Profiling and Identification of Peptide-Based Large Molecules

Helen Robinson, Ph.D Associate Scientist Covance Laboratories

There is a growing interest within the pharmaceutical industry in the use of large molecules and biotherapeutics as drug compounds. Incubating a variety of known peptides (ca. 25-50 amino acids) with rat kidney homogenate or cryo-preserved rat hepatocytes prior to analysis using a Waters Vion IMS-QTof, Covance shows how UNIFI workflows can be used to interrogate peptide metabolism data.

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.

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 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.

John Kellie, GSK: Microflow LC/MS for pre-clinical and clinical DMPK studies

Dr. John Kellie works in the Bioanalysis, Immunogenicity and Biomarkers group at GlaxoSmithKline (GSK), handling DMPK work for pre-clinical and clincal studies, specifically for quantification of biotherapeutics. He discusses how he monitors and quantitates masses of large molecules at both the peptide and intact proteins levels using the ionKey/MS system and SYNAPT G2-Si mass spec.

Pfizer: Microsampling and the bioanalytical challenges in their routine analysis

In this webinar, Dr Chris Holliman from Pfizer, Groton, discusses familiar challenges regarding sample volume requirements in the bioanalytical laboratory and how microflow LC/MS may help to address these concerns for the future.

It used to be that ultrasensitivity was the limiting factor in routine bioanalysis, but with the evolution of the triple quad mass spec, this is becoming less of an issue. We now face the continued drive by pharma to analyze smaller and smaller samples while obtaining more information per sample. The more contemporary question then becomes, is our current technology in pace to keep up? Dr Chris Holliman from Pfizer, Groton, will discuss the challenges his team faces as they determine drug exposure and how microflow LC/MS may fill the gaps we see today.