Large Molecule Quantification

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

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.

The Role of Mass Spectrometry in Biopharmaceutical Drug Discovery and Development

The discovery and development of biopharmaceuticals that target specific diseases can be transformative for people living with illness. However, bringing a new therapy to market is a prolonged and costly process mired in uncertainty. Ensuring safety, efficacy, and product quality is paramount. Biopharmaceuticals, by their nature, are highly complex. A myriad of heterogeneity can be intentionally functional, an unwanted consequence of manufacturing and storage, or generated by biological modification in vivo. Not all, but some post-translational modifications or biotransformations can impact development, manufacturing, safety, efficacy, and overall product quality. These critical quality attributes (CQAs) need to be identified, characterized, controlled, and monitored throughout the drug discovery and development cycle. Specialty measurement using mass spectrometry (MS) continues to play an ever-increasing role across the continuum.

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.

Introducing ProteinWorks - Standardizing High Performance Protein Quantification Workflows

This webcast will highlight ProteinWorks – A series of sample preparation kits designed to simplify, streamline and standardize LC-MS/MS protein quantification workflows. Data for infliximab, adalimumab, trastuzumab, bevacizumab and the total quantification of antibody–drug conjugate (ADC) T-DM1 will be shown as working examples. These generic, yet fully optimized kits and protocols enable novice and experienced scientists alike to perform robust protein quantification easily and routinely.

Quantification of Proteins in Complex Biological Samples by LC-MS/MS

In this mini-webinar you will learn about different LC-MS/MS approaches for quantitative protein bioanalysis with focus on biopharmaceuticals, biomarkers and targeted proteomics. Until recently the only way to quantify proteins in complex biological matrices like plasma or serum was by ligand binding assays using antibodies or antibody-like affinity ligands usually in the ELISA format. Recent developments in LC-MS/MS have opened the possibility to quantify proteins by Selected Reaction Monitoring (SRM) at low concentration levels making the technique a viable alternative to ligand binding assays. We will discuss the use of triple quadrupole mass analyzers, the workhorse instrument for the quantitative bioanalysis of proteins.

Top ten misconceptions about microflow LC/MS

You’ve heard a lot about microflow LC/MS. Are you cautious about making the switch? Do you still have questions or concerns about method development? We are going to use this time to review the top 10 misconceptions and challenges that we have heard and observed. Our hope is that after you have listened to this presentation, you will be able to make an informed decision on how microflow LC/MS will fit into your workflow.

Microfluidics for macromolecules: leveraging microflow LC/MS for quantitation of therapeutic peptides

This webinar will provide an overview of the utilization of microflow LC/MS for the quantitation of therapeutic peptides at Merck Research laboratories. An overview of the use of LC-MS for peptide analysis will be presented along with various case studies for in vitro and in vivo studies focused on the characterization of various drug metabolism and pharmacokinetic properties in a discovery (non-regulated) pharmaceutical research environment.