= Emerging. More than 5 years before clinical availability. (26.62%)
= Expected to be clinically available in 1 to 4 years. (38.91%)
= Clinically available now. (34.47%)
MSACL 2020 US : Ladwig

MSACL 2020 US Abstract

Topic: Proteomics

Podium Presentation in Room 5 on Thursday at 13:15 (Chair: Paula Ladwig)

MS Quantitation and/or Screening of Monoclonal Antibody Therapeutics: the Good, the Bad, the Ugly

Paula Ladwig (Presenter)
Mayo Clinic

Presenter Bio(s): Paula Ladwig is an associate development technologist coordinator for the Clinical Mass Spectrometry Development Laboratory at Mayo Clinic in Rochester, MN. Ms. Ladwig has developed, validated and published methods for the quantitation of monoclonal antibody therapeutics both by peptide and intact methods that have been successfully translated and implemented into a clinical laboratory. Paula is ASCP certified as a Medical Technologist. Paula has completed AACC’s Clinical Laboratory Leadership and Management Certificate Program, has been awarded both AACC NACB Distinguished Abstract Award and Outstanding Speaker Award. Paula is a volunteer for CLSI and is Chair of the Expert Panel on Evaluation Protocols. Paula holds a Master’s Degree in Biochemistry and Structural Biology from the Mayo Clinic Graduate School.

Authors: Paula M. Ladwig, M.S., MT(ASCP)
Mayo Clinic


Session Overview

The clinical laboratory will have many roles as monoclonal antibody therapeutics (t-mAbs) expand: identifying potential interferences in routine immunoassays; developing new assays to differentiate a t-mAb from an endogenous, disease-causing plasma cell clone and monitoring therapeutic drugs for better patient outcomes and assessing loss of response to therapy. This session will provide an overview of mass spec techniques available to the clinical laboratory for t-mAb detection and quantitation along with their advantages and disadvantages. Finally this session will offer a few examples of hurdles in the implementation into the clinical laboratory setting.

Target Audience

This session is intended for clinical laboratory directors and pathologists, clinical technologists, IVD manufacturers, pharmaceutical scientists, and anyone interested in the mass spectrometry applications for therapeutic monoclonal antibodies especially those involved in development of new methods for t-mAb monitoring.

Needs Assessment

There are over 60 different therapeutic monoclonal antibodies (t-mAbs) approved by the FDA; used to treat a variety of diseases. The market for monoclonal antibodies is rapidly growing, with over 500 new t-mAbs in several stages of development. Laboratorians are quite familiar with the detection, screening, and quantitative therapeutic drug monitoring for small molecules as the methodologies have been well established, therapeutic ranges for many drugs have been defined, and the metabolic pathways for many small molecules have been elucidated in detail. However, this is not the case for the t-mAbs. The detection, screening, and quantitative measurement of these monoclonal antibodies require different technologies.

Mass spectrometry is an important tool in the field of t-mAbs; mostly because it is relatively simple and so versatile once you understand how to apply the basic principles, challenges and limitations of each different approach and instrumentation. This session will provide examples of approaches for mass spectrometry assay development for chimeric, humanized and fully human t-mAbs quantitation; from peptide by quadrupole MS to intact or subunit detection by time-of-flight or orbitrap MS.

Learning Objectives

Following the completion of this session, the participant will be able to:

1. Describe mass spectrometry techniques available for the assessment of monoclonal antibody therapeutics along with their advantages and disadvantages.

2. Discuss screening and quantitation approaches.

3. Describe common hurdles and how to avoid them.

Financial Disclosure

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