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

    Frontiers in Bioprocessing: 2007

    Since the earlier edition of this volume in 2004, the science and art of bioprocessing has progressed through many small incremental steps, consolidating notable advances in speed, quality of products and ease of synthesis. The result is an overall improvement, which translates into better and more versatile production at substantially reduced cost. In this review we describe a variety of advances in processing technology including: (1) A continuing drive toward improved serum free and protein free culture media for mammalian cells; (2) redesign of bacterial expression systems in order to minimize inclusion body formation and optimize protein folding; (3) engineering of transformed mammalian cell lines using improved expression system to optimize underperformers; (4) newly configured transgenic plants, animals; (5) robotic peptide synthesis generating longer peptides at reduced cost; and (6) redesigned glycosylation systems, taking advantage of reengineered yeast strains. In the next few years we anticipate the development of: (1) further redesigned cells with even greater protein yields; (2) great reductions in the cost of cell culture media; (3) advances in computer technology for improving bioreactor performance; (4) use of protein design and protein evolution to improve quality and rates of protein expression; (5) approval by regulatory agencies of biologics produced in transgenic animals and plants; and (6) improvement in protein purification technologies. However, it does not appear likely that alternatives to mammalian cells will make significant inroads into the 90 % monopoly that this technology currently enjoys within the next two to three years. This is due to the numerous scientific, regulatory and technical hurdles that remain before transgenics, yeast, insect cells or bacteria will be viewed favorably by the biotechnology community.

    About the Author

    K. John Morrow, Jr., Ph.D., President, Newport Biotech
    Consultants, Newport, KY

    Dr. Morrow’s areas of interest include recombinant antibody technology, downstream processing, and cell culture technology. Morrow was a professor of Cell Biology and Biochemistry at Texas Tech University Health Sciences Center (Lubbock, TX) until 2003 when he joined Meridian. His academic research interests included cell genetics and molecular immunology. He is the author of 56 articles in refereed journals, and 60 review articles in books and in the biotech trade press on various aspects of biotechnology, especially as it relates to recombinant antibodies. Dr. Morrow has also published a book on cell genetics and two marketing studies in collaboration with Dr. Rathin Das. He was trained in genetics at the University of Washington (Seattle) and did postdoctoral studies at the Istituto di Genetica in Pavia, Italy and the Fox Chase Cancer Center, Philadelphia. He has taught college courses at the University of Kansas and at Texas Tech in human and molecular genetics and cell biology, general biology, and science and human affairs. His current research interests are in the field of genetically engineered antibodies.

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