OCT 25, 2018 09:00 AM PDT
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Mass Spectrometry Applications for Monoclonal Antibody Therapeutics: Which Road To Travel

SPONSORED BY: Agilent
C.E. CREDITS: P.A.C.E. CE | Florida CE
Speakers
  • Development Technologist Coordinator, Mayo Clinic's Mass Spectrometry Development Laboratory
    Biography
      Paula Ladwig graduated from the University of Wisconsin-Stevens Point with a bachelor's degree in chemistry and medical technology (ASCP-certified). She began her career at Mayo Clinic almost 20 years ago as a generalist in Mayo's Central Clinical Laboratory. While working, Ms. Ladwig obtained her master's degree in biochemistry and structural biology through the Mayo Clinic Graduate School of Biomedical Sciences. For the past 10 years, she has worked in developing mass spectrometry-based clinical assays. Currently, Ms. Ladwig is a development technologist coordinator for Mayo Clinic's Clinical Mass Spectrometry Development Laboratory where her focus involves the quantitation of therapeutic monoclonal antibodies from serum. Ms. Ladwig has developed and published methods for the quantitation of monoclonal antibody therapeutics both by peptide and intact methods.
    • Assistant Professor of Laboratory Medicine and Pathology, Mayo Clinic College of Medicine
      Biography
        Dr. Maria Willrich received her Ph.D. degree from the University of Sao Paulo, Sao Paulo in Brazil in 2011. She completed a two-year clinical chemistry post-doctoral fellowship at Mayo Clinic, in Rochester, Minnesota in 2014. Since then, she has acted as co-director in the Protein and Antibody Immunology Laboratories and the Clinical Mass Spectrometry Laboratory in the Department of Laboratory Medicine and Pathology at Mayo Clinic. Her research projects have focused on monoclonal antibody therapeutics test development, the complement system, and laboratory testing for the monoclonal gammopathies and analysis of protein in cerebrospinal fluid. She is currently an Assistant Professor of Laboratory Medicine and Pathology, Mayo Clinic College of Medicine. Peer-reviewed publications authored by Dr. Willrich and colleagues include 40 full-length articles and more than 50 abstracts.

      Abstract:

      DATE: October 25, 2018
      TIME:  9:00AM PDT

      There are over 60 different therapeutic monoclonal antibodies approved by the FDA; treating a variety of diseases, including solid-organ tumors, hematological malignancies, rheumatological disorders, and autoimmune gastrointestinal diseases. The market for t-mAbs is rapidly growing; worldwide sales are expected to be over $100 billion in 2018, and there are over 500 new t-mAbs in several stages of development. Laboratorians are quite familiar with the concept of therapeutic drug monitoring for small molecules; the methodologies are well established, therapeutic ranges defined, and metabolic pathways for many have been elucidated in detail. However, this is not the case for t-mAbs. The clinical laboratory will have many roles as 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; monitoring therapeutic drugs for better patient outcomes and assessing loss of response to therapy that is associated with formation of autoantibodies against the t-mAb. While proteins and peptides have traditionally been quantitated by immunoassays, tryptic peptide mass spectrometry has now also become well-established for proteins such as t-mAbs, with the advantage of not requiring antibody reagents. Tryptic peptide MS offers cost effective, high throughput, multiplexed assays when performed using triple-quadrupole mass spectrometers, which have been the instrument of choice in the clinical laboratories for many years due to their proven track record of providing precise and accurate quantitative results. The peptide method is limited when developing assays for humanized/human t-mAbs containing less than 5% of animal sequences. Therefore, alternative approaches for t-mAb quantitation needed to be developed along with extraction techniques. One of those approaches is the measurement of the immunoglobulin intact light chain by time-of-flight or orbitrap MS. 

      Learning Objectives:

      • List different types of monoclonal antibody therapeutics and their clinical applications
      • Describe mass spectrometry methods available for the assessment of monoclonal antibody therapeutics; e.g. peptide vs. intact
      • Discuss the different quantitation approaches to develop a new mas spectrometry assay for t-mAb assessment and which instruments to use

       

       

       

       

      For Research Use Only. Not for use in diagnostic procedures.


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