Our Commitment

Elion was founded to serve the analytical development and product characterization needs of the biopharmaceutical industry.  We offer a variety of services, including analytical method development, qualification and validation; analytical characterization testing of biologics; training in highly specialized analytical techniques; comprehensive data analysis including visualization and interpretation of complex data sets; and technical consulting.  We are committed to providing these services with unmatched quality.

Our Vision

We set the standard for characterization of biologics world-wide, providing the highest quality results to our clients and thereby helping to advance critical therapies.  

We provide proven and innovative analytical services to help our clients develop and commercialize life-changing biologics for the benefit of patients.

Leadership

  • John Gabrielson

    Chief Executive Officer
    Founding Partner

    John is accountable for directing Elion and defining long-term strategies for business development, scientific advancements, and company growth. Prior to Elion, John led a multi-disciplinary analytical organization at Amgen focused on developing and implementing biophysical and particle characterization methods for higher order structural characterization and comparability testing of all protein products from late-stage clinical development through commercialization and post-approval. He has developed a number of improvements to biophysical characterization methods, from which he has delivered invited presentations, been issued one patent, and written numerous articles and book chapters.

    John received his Ph.D. in Chemical Engineering from the University of Colorado. His research interests include protein higher order structure characterization, aggregation and particle formation mechanisms, and applications of statistical modeling and simulation to evaluate analytical method capability. 

  • Brent Kendrick

    Chief Scientific Officer
    Founding Partner

    Brent directs the consulting division, manages client relationships, and provides scientific oversight for Elion. During his 18 years at Amgen, Brent served as a formulation team leader in Pharmaceutics, developed and patented a lyophilized formulation, managed a clinical analytical laboratory team in Quality, served as a product quality leader, held roles as Analytical Sciences team leader for multiple late stage clinical products, and was drug substance process team leader for a product from Phase III through commercial launch.  As Director of Amgen’s Attribute Sciences organization for late stage clinical and commercial products, Brent led a team of over 100 staff across multiple sites worldwide.  He led his group through multiple successful product approvals, technology transfers, validation campaigns and biosimilarity/comparability studies, while leading the creation of cross-functional guidelines for comparability and method development strategies.

    Brent received his Ph.D. in Pharmaceutical Sciences from the University of Colorado and has been an adjoint faculty member at the University of Colorado for over 15 years.   Prior to graduate school, Brent was a Surface Warfare Officer in the United States Navy.

  • Kelly Arthur

    Chief Scientist
    Founding Partner

    Kelly directs the analytical characterization services at Elion providing specialized analytical testing and comprehensive data analysis to our clients. Prior to Elion, Kelly led the Global Biophysical Characterization group at Amgen responsible for the higher order structural characterization of all late stage clinical development and commercial products. In this role she supported method development, product characterization,comparability and reference standard characterization for more than 20 products. Her published works include application of biophysical characterization techniques to elucidate protein structure-function relationships, development and application of quantitative spectral similarity methodologies, and analytical ultracentrifugation for application in biopharmaceutical product characterization.

Products developed

21

Average Years of Industry Experience

19

Our Advisory Board

  • Theodore W. Randolph

    Gillespie Professor
    Co-Director of the Center for Pharmaceutical Biotechnology
    University of Colorado

    A professor of Chemical and Biological Engineering at the University of Colorado since 1993, Theodore W. Randolph is a renowned expert in formulation and stabilization of therapeutic proteins, methods to probe, manipulate, and control protein folding, mechanisms leading to protein aggregation and particle formation, and most recently, immunogenicity of protein therapeutics. Dr. Randolph has co-founded three companies based on technology developed in his laboratory, and he is a co-inventor on 27 issued patents. His research innovations have been recognized by the American Institute of Chemical Engineers’ Professional Progress Award in 2005 and the American Society of Engineering Education’s Dow Lectureship Award in 2007. 

    Dr. Randolph co-directs the Center for Pharmaceutical Biotechnology, a joint research center involving the Boulder and Denver campuses of the University of Colorado, and he is a fellow of the American Association of Pharmaceutical Scientists.

  • Richard K. Burdick

    Emeritus Professor of Statistics
    Arizona State University

    Richard K. Burdick is an Emeritus Professor of Statistics, Arizona State University (ASU), where he instructed undergraduate and graduate students for 29 years.  Following his tenure at ASU, Dr. Burdick was a Quality Engineering Director for Amgen Inc. for 10 years.

    Dr. Burdick’s research and consulting interests consider several CMC statistical applications including comparability studies, stability data analysis, analytical method validation, quality by design process characterization, and analytical similarity for biosimilar products.  He has written over 60 journal articles and three books, including Confidence Intervals for Random and Mixed ANOVA Models with Applications to Gauge R&R Studies, (with C. M. Borror and D. C. Montgomery) and Confidence Intervals on Variance Components, (with F. A. Graybill).

    Dr. Burdick is a Fellow of the American Statistical Association and a member of the American Society for Quality. He has served on the USP Statistics Expert Committee since 2010.