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

    Cell Line Engineering and Development: Case Studies

    The demand for human therapeutics derived from mammalian cell culture is projected to grow many fold in the coming decade. This higher demand will be driven by the introduction of new therapeutics and the further expansion of existing markets for such products. Recent projections estimate that as many as one quarter of all new therapeutic drugs in clinical development require mammalian cell culture production systems. Over the past three decades there have been tremendous advances in the expression of recombinant proteins and cell line optimization in mammalian production systems. The continued growth of this market will drive further improvements in productivity. The focus of this chapter is on some of the innovative molecular biological tools being developed to further enhance the production of recombinant proteins in mammalian cell culture hosts.

    About the Author

    Thomas Primiano, Ph.D.
    Clonex Development, Inc., Chicago, IL

    Dr. Primiano is an expert in protein purification from mammalian tissues and cells. Dr. Primiano received his Ph.D. from Northwestern University in 1992 in the field of Molecular Pharmacology where he studied the induction of glutatione S-transfersases by xenobiotics. Dr. Primiano has held faculty positions at Johns Hopkins University in Toxicology, where he cloned novel genes associated with cancer chemoprevention, and the University of Illinois at Chicago in Molecular Genetics, where he discovered new molecular targets for cancer therapy. Dr. Primiano has published over 50 articles, reviews, abstracts, and book chapters. CDI, founded in April, 2000, genetically engineers senescence- triggering factors into commercial cell lines to maximize the production of biopharmaceuticals.

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