Supporting the Development of Protein Drugs By LC-MS-Based Bioanalysis

Life Sciences, Drug Discovery & Development, Preclinical,
  • Tuesday, October 06, 2020

Over the past decade, the use of LC-MS for the quantitative determination of proteins in biological samples has increased considerably, and this technique can now be considered an established bioanalytical platform for the quantification of macromolecular drugs and biomarkers, next to the traditional ligand-binding assays (LBA’s). Because of its fundamentally different analytical principles, LC-MS can provide qualitative and quantitative information about proteins in biological samples that is complementary to LBA results.

This webinar will give an overview of recent developments in the field of protein LC-MS, as applied to support the (pre)clinical development of macromolecular pharmaceuticals. Attention will be paid to technical developments with regard to sample handling, chromatography and MS detection of both digested and intact proteins, and the relative merits of different approaches, such as immunocapture and generic extraction, or unit- and high-resolution MS, will be compared and discussed.

In addition, advances in understanding the actual meaning of the results will be highlighted. Because of the complex structure of proteins and their often neglected in vivo behavior, quite different concentration results may be obtained when different analytical techniques are applied, and a proper understanding of what a result represents is essential. The effect of protein–protein interactions, biotransformation and the occurrence of protein isoforms on the analytical result will be addressed. Practical examples from both preclinical and clinical analysis, for biopharmaceuticals and biomarkers in different biological matrices, will be used as illustrations.

Speaker

http://Nico%20Van%20De%20Merbel

Nico van de Merbel, Senior Director, Bioanalytical Science, PRA Health Sciences

Nico van de Merbel is senior director of bioanalytical science at the Bioanalytical Laboratories of PRA Health Sciences in Assen (The Netherlands) and Lenexa (KS, USA).

His field of expertise is the bioanalytical application of chromatographic methods for small and large molecules. He is responsible for research, method development and validation of chromatographic methods for biological samples. Nico obtained his M.Sc. in toxicology and his Ph.D. in analytical chemistry at the Free University in Amsterdam. He holds an honorary professorship in Industrial Bioanalysis at the University of Groningen (The Netherlands). He has 30 years of experience in quantitative bioanalysis in academia and industry and has been employed with Pharma Bio-Research/PRA since 1995.

Message Presenter

Who Should Attend?

  • Scientists in small, mid and large pharma who develop and validate LC-MS methods for proteins, in support of (pre)clinical studies
  • All other industrial scientists with an interest to learn more about the possibilities of LC-MS for protein quantification
  • Academic and research scientists who are interested in the technical and conceptual developments of protein LC-MS in an industrial setting
  • (Project) managers and outsourcing/procurement staff involved in bioanalysis supporting the development of protein drugs

What You Will Learn

In this webinar, participants will learn:

  • What are the recent technical advances in protein LC-MS?
  • How do the different technical approaches compare from an analytical point of view?
  • What is the relevance of the complex structure and behavior of macromolecules for the meaning of a concentration result?
  • How does the selection of a particular technical approach impact the result that is obtained?

Xtalks Partner

PRA Health Sciences

PRA Health Sciences recognizes that the world of drug development is complex and dynamic, and that’s why PRA has designed two laboratories to meet those challenges. PRA offers the highest quality services for pharmacokinetic, immunogenicity, biomarker analysis and CMC analysis, comprising a wide range of platforms for small molecules, large molecules and cell-based entities.

PRA’s Laboratories for Drug Development are managed, staffed, and supported by industry-leading experts who have the scientific knowledge and experience necessary to successfully deliver the most complex of studies.

The GLP & GMP compliant facilities in the USA and the Netherlands adhere to the latest global regulatory guidelines and expectations. PRAs technology investments and innovative service offerings are key components of goals and strategies for developing solutions for clients.

No one understands the daily pressure of tight deadlines better than the colleagues at PRA laboratories, because PRA realizes that behind every sample we analyze, a patient is waiting to be treated.

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