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.
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.
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 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.