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Advances in Large-Scale Biopharmaceutical Manufacturing
and Scale-Up Production*, 2nd Edition

    Simulated Moving Bed Chromatography

    Abstract

    Chromatographic processes are an important part in the production of bio-pharmaceuticals. Polypeptides, proteins, enzymes, and antibodies are captured, purified and polished by ion exchange, size exclusion, reverse phase, hydrophobic interaction or affinity chromatographic processes. Their scales range from a few kilograms a year of very potent compounds to large bulk productions of several tons. Only recently research groups primarily from academics have started to investigate continuous operating technologies such as simulated moving bed chromatography (SMB) to increase productivity of purification processes for bio-pharmaceuticals. SMB technology has been used in large scale operations in the petrochemical and sugar industries for almost half a century. Ten years ago this technology has became a valuable tool for bringing synthetic pharmaceuticals faster to the market. Up to this date there is no known production process in the bio-pharmaceutical industry where SMB units have been implemented. The following chapter answers questions about barriers hindering the implementation of continuous chromatographic processes into the manufacturing of bio-molecules. Guideline will be provided how to overcome these barriers; thus, continuous chromatographic processes, such as SMB, become part of our platform in the bio-pharmaceutical industry. In particular, column and equipment hardware, packing material, solvent systems, and their interaction with the more sensitive bio-molecules will be discussed.

    About the Author

    Dr. Kathleen Mihlbachler, Ph.D., Eli Lilly and Company
    IBO MS&T Commercialization Tech Center, Lilly Corporate Center Indianapolis, IN
    Dr. Kathleen Mihlbachler received her doctoral degree in Chemical Engineering from the Otto-von-Guericke University Magdeburg, Germany. In her doctoral research conducted at the Oak Ridge National Laboratory and the University of Tennessee, she focused on continuous chiral separation via simulated moving bed chromatography. Previous graduate research areas include protein separation using gradient chromatography and the ultrafiltration. After completion of her doctoral degree, she joined Pfizer (Pharmacia) working in the area of large-scale chiral and achiral separation. Currently, Dr. Mihlbachler is a Research Scientist in the MS&T organization at Eli Lilly and Company where she is involved in the modernization of existing manufacturing processes of biomolecules that also included the evaluation of continuous chromatographic processes. Since 2002 she has taught a workshop about determination and modeling of adsorption isotherms at the annual Prep Symposia.


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