Large Molecule Quantification

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

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The Role of Mass Spectrometry in Biopharmaceutical Drug Discovery and Development
January 2018

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.

Accurate Quantification of intact Insulin-like Growth Factor I (IGF-I) using High Resolution Mass Spectrometry (HRMS) for Clinical Research
January 2018

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.

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.

Simplifying Protein Quantification Workflows

Choosing the appropriate method to quantify important protein sample streams can be a daunting task even for the most seasoned laboratory professional. This GEN webinar will provide insight on overcoming challenges that are often encountered when implementing LC-MS approaches for protein quantification. Moreover, our presenter will outline the essential assay parameters that need be addressed in order to facilitate and enhance each researcher’s scientific objectives.

The Versatility of Microflow LC/MS – Making High Sensitivity Applications More Routine with ionKey/MS

Originally launched in response to the need for robust, high sensitivity microflow LC/MS applications, the integrated microfluidic tile-based ionKey/MS™ platform continues to evolve as a system that can be implemented for routine applications. ionKey/MS™ has quickly gained traction in new application spaces yielding a more functional and flexible system. These new areas include quantification of intact and digested monoclonal antibodies, thyroglobulin, opioids in oral fluid, estradiol, and steroids.

Panel discussion on peptide and large molecule analysis by LC-MS

During this panel discussion we discussed what clinical stage peoples’ assays are used in, reflecting on what this indicates for the use of the technique in drug development. We also discussed sample preparation techniques used, covering proteolytic digestion and immunocapture techniques, with our panelists providing advice on best practices.

The heights of biopharmaceutical complexity and the current reach of analytical instrumentation

Monoclonal antibodies are currently the fastest growing segment of therapeutic proteins in the pharmaceutical industry, partly due to faster approval rates than small molecules and a large untapped market. Understanding primary structure of the protein with post-translational modifications, can be important to assessing an antibodies efficacy and safety.