Vector and cell engineering to increase productivity and stability of recombinant protein production in CHO cells

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Biologics (proteins, antibodies and vaccines) account for a significant (7.5%) and increasing share (20% annual growth) of new therapeutics entering the clinic and the market, displacing the traditional small-molecule chemical compounds; 33% of all drugs currently in development are biologics (PharmaVision 2009. Delivering New Biopharmaceutical Therapies: Challenges & Opportunities). Together with vaccines and gene therapy products, therapeutic proteins represent half of the FDA-approved therapeutics in the pipeline. As a result, we are witnessing a spectacular emergence of biologics in the top 10 most selling drugs. In 2000, there was only one biologic in the top 10: erythropoietin. The forecast for 2014 indicated that there would be 7 biologics in the top 10: 5 humanized antibodies and 2 recombinant proteins (Biotech 2010 Live Sciences: Adapting for success, Burrill & Company). Hence, therapeutic antibodies and derivatives thereof have the lion's share of this market. In order to expand their applications, significant improvements are required to lower their production costs while improving their quality. Thus, it is estimated that the cost of production of therapeutic antibodies must be reduced by at least one order of magnitude in order to ensure economic viability of a significant proportion of the products currently in clinical trials. Therefore much remains to be done to improve the efficiency of high-producing clones generation and we will explore new vector and cell engineering strategies toward that goal.