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

    Downstream Processing: Removing Economic and Technical Bottlenecks

    Abstract

    The biopharmaceuticals sector is the fastest growing segment of the pharmaceutical market, but such products are also among the most complex and expensive to manufacture. Except for a handful of very well-characterized biologics, proteins cannot be characterized as precisely as small molecule drugs, so regulatory authorities instead approve the production process, which requires that each stage is controlled and validated so that the product remains within set tolerances and specifications. Improvements in the upstream production phases have increased productivity, but this is leading to bottlenecks in downstream processing as current technology platforms reach their limits of throughput and scalability. Innovative solutions are required, which may include the return to simpler and less expensive separation technologies, the use of disposable modules to limit process down time and cleaning/ validation cycles, and the integration of improved processes which are both robust and scalable to cope with the increased demands of today’s fermentation systems and tomorrow’s transgenic bioreactors.

    About the Author

    Uwe Gottschalk, Ph.D., Sartorius AG
    Dr. Gottschalk is Group Vice President, Purification Technologies, with a global responsibility for bioseparation products at Sartorius AG. He worked in several capacities for Bayer Health Care from 1991-2004 and became head of the GMP protein purification facility in Wuppertal (Germany). He was responsible for the production of monoclonal antibodies and other recombinant proteins using various expression systems. Dr. Gottschalk holds a Ph.D. in Chemistry from the University of Münster. He is a member of BioPharm International’s editorial advisory board and has written one book, five book chapters and many other publications in the areas of biotechnology and somatic gene therapy. In academia, Dr. Gottschalk is Head Lecturer at the University of Duisburg–Essen (Germany) and also lectures at the Ecole Polytechnique Fédérale de Lausanne EPFL (Lausanne, Switzerland).


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