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Analytical Chromatography of Orencia™ (Abatacept, CTLA4-LG) Dave Kirkley, Senior Research Investigator II, Bristol-Myers Squibb ABSTRACT Biopharmaceutic molecules require an in-depth analytical characterization and release testing in order to qualify as a therapeutic drug. Different methods of chromatographic separation can be performed to analyze, characterize, and assay biological drug substances. Orencia™ (Abatacept, CTLA4-Ig) is a homodimer fusion protein biotherapeutic that was FDA approved for use against rheumatoid arthritis and is targeted for other autoimmune diseases like lupus, MS, Crohn’s disease, and IBS. To fulfill FDA requirements, many chromatographies were developed to assay and characterize this molecule. Various testing methods were developed and validated which include affinity, size exclusion, ion exchange, chromatofocusing, and reversed-phase chromatography. This presentation will center on the use of these chromatographies to analytically assess the unique complexity in the production of Orencia™ that insures quality, efficacy, and safety for patients. BIOGRAPHY Dave Kirkley is currently a Senior Research Investigator II at Bristol-Myers Squibb in Syracuse, NY. He is a native of the Syracuse area having attended Fayetteville-Manlius High School. This was followed by undergraduate work at the College of Wooster (in Ohio, BA in chemistry) and graduate school at University of Texas at Arlington (MA in chemistry). He studied and worked on the biosynthesis of the thiazole moiety of thiamine contributing two papers to the field. Following graduate school Dave taught at colleges SUNY at Geneseo, Herkimer Community, and Hamilton and then switched to industry concentrating on developing HPLC chromatography methods of small molecules in the pharmaceutical industry. This started at Bristol-Myers in Syracuse followed by work at Ayerst in Rouses Point, NY and Pennwalt Pharmaceuticals in Rochester, NY. In 1985 Dave moved on to perform large molecule HPLC chromatography at Praxis Biologics in Rochester, NY and then back to Bristol-Myers Squibb until present. In the 23 years Dave has spent at BMS, he first introduced analytical size exclusion, protein A affinity, hydrophobic interaction, ion exchange chromatography, and N-linked oligosaccharide analysis as well as reversed-phase peptide mapping. By using these methods and more, the products which include OrenciaTM, NulojixTM, and antibodies like YervoyTM became fully characterized and acceptable to the FDA leading to these new licensed and marketed biologics.