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

    Purification of Monoclonal and Genetically Engineered Antibodies


    The production of monoclonal antibodies for therapeutic use requires the use of modern separation techniques to assure product purity and safety. This chapter discusses modern chromatographic methods for the capture and polishing of therapeutic antibodies. The capture section focuses on the use of affinity chromatography, immobilized Protein A. A case study describing the development of a robust, industrial affinity resin is presented. In the case study data on base matrix selection, capacity optimization and stability to hydroxide clean in place solutions is presented. The chapter concludes with a brief review of polishing strategies.

    About the Author

    Robert M. Kennedy, Ph.D.
    Process Development, Protein Separations, GE Healthcare Piscataway, NJ

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