Integrating Design and Control with Six-Sigma for Bioprocessing Applications

With worldwide revenues in excess of $400 billion in 2003, it is not surprising that the pharmaceutical industry can justify the investment of up to $ 800 million in the development of a new drug [1, 2]. However, with the main focus being on reducing time-to-market, the industry commonly relies on poor operating practice with regards to production losses, with low sigmalevels in the range 2-3 being commonplace, equivalent to production losses of as much as 35% due to off-quality products. Clearly, a direct consequence of each percent increase in acceptable production has a potential annual benefit of some $ 4 billion. It is also self-evident that a pharmaceutical process whose sigma-level is improved will also exhibit reduced cycle times, and increased overall efficiency and quality [3]. These commendable objectives can be achieved using a proposed novel approach, shown schematically in Figure 1, which combines: