Biotechnology manufacturers must build significant excess capacity to deal with the highest demand scenario - no matter how unlikely that may be.
This is according to research carried out by Bioproduction, which presented the results at this year's Biomanufacturing Development (BMD) Summit, in San Francisco, California.
The research aimed to quantify how to value 'flexibility' in a biopharmaceutical manufacturing facility.
Bio-G based its research on the wild fluctuations in demand and excess capacity over the past 10 years, from an extreme capacity shortage in the early 2000s to the current glut of capacity in large biotechs in 2009.
The research presented evidence that this 'feast or famine' capacity environment was due to the need for high service levels coupled with the uncertainties in the clinical-trials process.
Bio-G presented data from a large biopharmaceutical manufacturer showing that clinical trials create a vast range of possible final demands, where success or failure in each phase of trials either creates a blockbuster or a relative flop.
This, coupled with the long lead times to build new facilities (five-to-seven years) means that biotech manufacturers must build significant excess capacity to deal with the highest demand scenario - no matter how unlikely that may be.
Bio-G showed that a flexible facility in this environment is actually one that can be quickly built and licensed - in as short as two years rather than the current five-to-seven year timeline.
Such a flexible facility is 22 per cent less likely to be significantly over-sized and 14 per cent less likely to be smaller than the required capacity.
These risks translate into tens of millions of dollars in potential savings for the average biotech manufacturer, and hundreds of millions of dollars for large manufacturers.
