LC-MS: Shedding light on host cell protein impurities in biopharmaceutical drugs
SelectScience: Mastering LC-MS in biopharmaceutical analysis - Session 1: LC-MS: Shedding light on host cell protein impurities in biopharmaceutical drugs
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
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.
Presenter: Thomas Kofoed, PhD (Co-founder and CEO, Alphalyse)
Dr. Thomas Kofoed holds a PhD in Organic Chemistry and a BSc in Business Administration. He has over 15 years of management experience in the biotech industry and has set up business relationships with hundreds of biopharmaceutical companies. As CEO of Alphalyse, his main focus is putting together a diverse team of highly skilled employees creating an innovative environment focusing on quality and customer needs.
Presenter: Dr. Angela Fernandez (Mass Spectrometry Team Leader & Project Manager, Leanbio Pro)
Dr. Angela Fernandez has a PhD in Biochemistry and Molecular Biology, and over a decade of experience in research and development in the biopharmaceutical industry and academia. Her expertise working in contract research organization (CRO) and CDMO companies includes biophysical and biochemical techniques for protein characterization, mass spectrometry-based analysis of new biological entities, and a comprehensive knowledge of drug development processes in a regulatory environment. Dr. Fernandez has established a new mass spectrometry platform from inception, expanding Leanbio's service offerings.
Presenter: Stephen Lock, PhD (Senior Market Development Manager, Biopharma, SCIEX™)
Dr. Stephen Lock obtained his PhD in Physical Organic Chemistry from the University College of Swansea and is a chartered chemist and a member of the Royal Society of Chemistry. He has worked for SCIEX™ in various technical roles for over 25 years, and is currently the EMEAI BioPharma Senior Market Development Manager. He is also an Adjunct Professor at the University of Pannonia where he acts in a volunteer role as a Scientific Advisor for the Horváth Csaba Memorial Laboratory, where he provides technical advice and supports the group’s fundamental research and development of new applications for capillary electrophoresis.
Presenter: Dr. Carrie Haslam (Associate Editor, SelectScience)
Dr. Carrie Haslam is an Associate Editor at SelectScience, playing a key role in content production and specializing in Materials Science, Alzheimer’s disease and Clinical Diagnostics. Carrie completed a Ph.D. from The University of Plymouth, where she developed graphene-based biosensors for the early diagnosis of Alzheimer’s disease.