Ligand Binding Assays and Hybrid LC-MS Quantitation of Biotherapeutics and Biomarkers

The need to quantitate biotherapeutics has been in demand for a long time. Historically, ligand binding assays have been the method of choice for this measurement. However, as technology has advanced, the use of mass spectrometry has gained a lot of momentum in the last several years. With both quantitation methodologies now available, the obvious question arises, “How do you choose which approach to use: ligand binding assays or mass spectrometry?”

In many cases, either technology can answer the question, but there are definitely times when one technology has advantages over the other. This webinar will give an overview of each approach and discuss the types of questions (such as, “what reagents are available?”) that will help guide you to choose the most appropriate technology. For ligand binding assays, our featured speakers will discuss the most common assay platforms as well as each platform’s limitations. This webinar will also explore reagent needs that will help ensure specificity and adequate sensitivity of the method, as well as some sample preparation techniques that may be useful for both the liquid chromatography-mass spectrometry (LC-MS) and ligand binding assay technologies.

In addition, the speakers will discuss and highlight various approaches for using immunoaffinity LC-MS or hybrid LC-MS, from enrichment at the protein level to enrichment at the peptide level using either bead-based or column-based enrichment strategies. They will also give examples or case studies of where each technology was applied successfully and where they had to make a switch due to some assay issue. Unfortunately, many people choose their quantitative approach based on their capabilities (ie. a mass spectrometry lab will do hybrid LC-MS and a ligand binding assay lab will do ligand binding assays). However, in some cases, the feasibility of both technologies can initially be considered before a final decision is made. KCAS has deep expertise in both areas and can help to guide and ensure the best approach is chosen to answer the question. 

Speakers

Dawn Dufield, Director, BioPharma Services, KCAS Bioanalytical & Biomarker Services

Dawn R Dufield, Ph.D. is the Director, BioPharma Services at KCAS.  She received her Bachelor’s degree in Chemistry from Southwest Missouri State University, Springfield, MO in 1992 and her Ph.D. in Chemistry (Bioanalytical) in 1997 from the University of Kansas.  She joined Monsanto in 1997 in St Louis, MO which transitioned into Pfizer in 2004.  She has been with Pfizer and legacy companies for over 20 years and has just recently joined KCAS to start a new large molecule LC-MS/MS group. Dr Dufield has been working in the LC-MS/MS field since 1997.  She has extensive experience in developing qualitative and quantitative LC-MS/MS assays for both large and small molecules.  She has developed numerous assays using both traditional and immunoaffinity enrichment approaches.  She was one of the early pioneers of using immunoaffinity combined with LC-MS/MS to offer additional selectivity which is now commonly referred to as Hybrid LCMS.  She currently is a member of the AAPS Mass Spec Protein Bioanalysis Committee (MSPBC) and an active member of the American Society for Mass Spectrometry (ASMS).  She has numerous publications and presentations in her field and recently contributed to a white paper on recommendations for validation of LCMS based bioanalytical methods for protein biotherapeutics.

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Franklin Spriggs, Director, BioPharma Services, KCAS Bioanalytical & Biomarker Services

Mr. Franklin P. Spriggs is the Director of Biopharma Services at KCAS. He received his B.S. in microbiology from Ohio University in 1998. Upon graduation he moved to New Haven, Connecticut to join CurGen Corp, a small biotechnology company working in the area of genomics and protein binding interactions. In 2005, Mr. Spriggs left New England and headed to southern California to join Amgen, Inc in Thousand Oaks. While at Amgen, Mr. Spriggs had the opportunity to learn and build expertise in regulated large molecule bioanalysis. Late 2007 saw Mr. Spriggs leave California and travel back to the northeast to join Pfizer, Inc in Groton Connecticut. While at Pfizer he applied the knowledge he had learned while at Amgen and began to participate in the American Association of Pharmaceutical Sciences (AAPS) where he has held positions in both the BIOTEC and Regulatory Sciences sections. In 2015 Mr. Spriggs received his M.S. in Regulatory Affairs and Quality Assurance from Temple University before transitioning out of the pharmaceutical industry to the world of the Contract Research Organization (CRO). Previous to KCAS, LLC Mr. Spriggs spent a 2 year tenure at another CRO in Indianapolis, IN, AIT Bioscience as the Ligand Binding Assay Group Leader.

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