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

    Increasing Performance of Mammalian Expression Platforms

    Biotherapeutics play a critical role in the treatment of diseases that affect the human condition. The biological activity of the great majority of these therapeutic proteins depends on correct posttranslational modifications best achieved by mammalian expression systems. The process of creating a suitable mammalian cell expression system for protein production essentially has four steps: (1) Constructing a suitable vector containing the gene(s) of interest, (2) Production of materials for preclinical evaluation, (3) Creation of stable clones expressing the protein of interest, and (4) Media development to optimize nutrient levels for the production clone. This expression system can then be utilized in process development and scale-up studies for cGMP manufacturing. In this chapter we will discuss the upstream issues related to Vector construction, Transient expression, Cell Line Development, and Medium Optimization for protein production in mammalian cells.

    About the Authors

    Trent Carrier, Ph.D.
    Director Business Development, PD-Direct Services

    Dr. Carrier is the Director of Business Development for PD-DirectTM manufacturing services, where he oversees the integration of Invitrogenís process development services in support of therapeutic product development. In 1998, Dr. Carrier received his Ph.D. in chemical engineering from the University of California, Berkeley with a focus on microbial pathway engineering. Prior to joining Invitrogen in 2005, Dr. Carrier worked in Vaccine Technology and Engineering at Merck and Co where he supported manufacturing, facility design, and technology transfer for microbial and cell-culture products.

    Mugdha Gadgil, Ph.D.
    Scientist, PD-Direct Services

    Dr. Gadgil recently joined PD-DirectTM as a Scientist, Cell Culture Development, where she oversees Cell Line Development operations for protein production. She obtained a Ph.D. degree in Chemical Engineering from the University of Minnesota in 2004. Her research was focused on studying the molecular response of cells to stress. Dr. Gadgil has extensively used the DNA microarray technology to probe changes in bacterial and mammalian transcriptomes to identify targets for metabolic engineering. Her postdoctoral work involved developing a systematic approach for mining microarray data to unveil genetic markers associated with high productivity using novel statistical approaches.

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