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Overview

Mastering LC-MS in biopharmaceutical analysis

LC-MS has been used for biopharmaceutical analysis for over 20 years and, in recent years, the demands of the industry have expanded significantly for this technique. This is due to drug classes expanding from monoclonal antibodies (mAbs) to include oligonucleotide and mRNA therapies, as well as novel protein-based drugs.

This webinar series explores the pivotal role of LC-MS in biopharmaceutical development, outlining the use of LC-MS for host cell protein impurity analysis, the capabilities of the ZenoTOF 7600 system for protein characterization, and the application of LC-MS in oligonucleotide and mRNA lipid nanoparticle analysis. These webinars provide crucial insights into the evolving landscape of LC-MS technology, highlighting it as an indispensable tool for ensuring the safety, efficacy, and purity of the next generation of life-saving drugs.

Session 1: LC-MS: Shedding light on host cell protein impurities in biopharmaceutical drugs
Monday, November 27, at 11:00 GMT / 12:00 CET / 06:00 EST / 03:00 PST

The manufacturing of biotherapeutics, including proteins, vaccines, and cell and gene therapy products, is complex. This complexity often leads to the presence of process-related impurities originating from various organisms. A commercial host cell protein (HCP)-ELISA kit is often not available for the cell line or is not suitable for the specific process, due to a low HCP coverage. Creating a tailored ELISA for the specific process is not always practical, especially when there is limited time for product development. In such cases, utilizing HCP analysis through LC-MS proves highly effective, offering several solutions and numerous benefits.

In this expert webinar, discover how LC-MS allows quantitation of total HCP amount at ng/mL in drug substances, while also identifying and quantifying individual HCP in a sample.

Session 2: Advancing protein biotherapeutics characterization with cutting-edge LC-MS
Monday, December 4, at 11:00 GMT / 12:00 CET / 6:00 EST / 3:00 PST

At the core of Leanbio's operations is the ZenoTOF 7600 system, a mass spectrometry (MS) platform for comprehensive protein characterization, designed to provide critical support for process development during manufacturing. This tool helps to determine the exact molecular weight and to identify product variants through intact mass analysis. It also supports sequence confirmation, analysis of post-translational modifications (PTMs), investigation of glycopeptides, and determination of disulfide bond assembly via peptide mapping.

In this webinar, discover more about the ZenoTOF 7600 system, and learn how Leanbio Pro provides the biopharmaceutical industry with analytical tools and expertise, contributing to a deeper understanding of intricate protein structures and their significance in therapeutic development.

Session 3: Enhancing the characterization of mRNA lipid nanoparticle drugs and vaccines with new LC-MS solutions
Monday, December 11, at 11:00 GMT / 12:00 CET / 6:00 EST / 3:00 PST

In this webinar discover how a quadrupole time-of-flight (QTOF) system can be used for high-resolution quantitation of oligonucleotides. Understand how advancements in MS/MS scanning sensitivity and quantification, coupled with user-friendly software solutions, facilitate the identification of impurities, and enhance the characterization of oligonucleotides. Plus, learn about the application of LCMS/MS in conjunction with ion pairing or HILIC chromatography for detecting oligonucleotides in biological extracts.

In addition, explore the transformation of oligonucleotides into larger RNA sized molecules, and discover the role of LCMS in characterizing these expanded molecules, as well as the lipid nanoparticles utilized as carriers for these novel drugs.

Thomas Kofoed, PhD
Co-founder and CEO
Alphalyse
View Biography

Dr. Angela Fernandez
Mass Spectrometry Team Leader & Project Manager
Leanbio Pro
View Biography

Stephen Lock, PhD
Senior Market Development Manager, Biopharma
SCIEX™
View Biography

Dr. Carrie Haslam
Associate Editor
SelectScience
View Biography