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Sep 15, 2011 (Vol. 31, No. 16)

Expression System Gains Lead to High Protein Yields

Current CHO Cell, E.coli, and Yeast Platforms Creating a Healthy Dose of Idle Capacity

  • Is Current Idle Capacity an Asset?

    For all expression systems, there continues to be significant underutilized capacity. Survey data shows that utilization has stabilized at what seems to be a fairly healthy and, perhaps, even optimal level. While downstream purification is now noted most often in the study as the primary choke point for larger-scale manufacture, upstream manufacturing remains the primary area affecting industry capacity and production.

    The decrease in industry capacity utilization is not the result of an industry slow-down or contraction. Rather, despite the world’s economic problems, in the past decade and even recent years, biopharmaceutical revenue (and manufacturing volume) has increased steadily, at an annual rate commonly cited as 15%–20%.

    In the early 2000s, there were concerns that the biopharmaceutical industry would soon face a severe lack of capacity. Incremental increases in protein yields largely resulting from improvements in expression systems and facility expansions have reduced capacity constraint concerns.

    Capacity utilization rates for mammalian cell systems have fallen from 76.4% (likely near the practical upper limit of operational capacity) in 2004 to the current 61%, while bacterial capacity fell from 71% in 2004 to 53.6%.

    Capacity utilization rates are slightly higher (less idle capacity) in Europe vs. U.S., e.g., 64.7% and 62.1%, respectively, for mammalian systems and 54.6% vs. 53.0%, respectively, for microbial systems.

    Idle capacity in some industries is viewed as a waste of resources, but in biomanufacturing it can also be an asset, enabling more flexible manufacturing and providing insurance against production shortfalls that can result in disastrous supply disruptions. Idle capacity can also allow product manufacturers to become opportunistic CMOs.

    A number of current companies holding large production capacity, e.g., banks of 10,000 L bioreactors, are now offering CMO services. The current moderate excess capacity suggests a healthy industry having “flex” or buffer capacity to meet near-term demand, avoid supply disruptions resulting from contamination and other processing failures, and meet coming years’ requirements for increased manufacturing volumes and new products.

    Biopharmaceutical manufacture is an industry where the lack of capacity can lead to product and even company failure, with the costs and ramifications of not having available capacity much more severe than having idle capacity. Industry-wide incremental increases in expression yields and maintenance of a moderate level of bioprocessing facility utilization will enable companies, and the industry as a whole, to manufacture products unencumbered by the fear of a lack of manufacturing infrastructure.

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