CMO


Future Manufacturing Constraints Innovative Technologies the Solution: Single-Use Devices, Higher Titer, Continuous


Eric S. Langer


President and Managing Partner BioPlan Associates, Inc.


Around 2003 was a peak crunch-time or period of concern that severe bioprocessing capacity shortages would develop, with utilization rates peaking then at 76% for mammalian systems and many potential blockbusters in the pipeline. The subsequent expansion of capacity, with many new facilities coming online, brought utilization rates down, so that by 2006 a rather stable and healthier capacity utilization rate in the 60% - 67% range was attained.


Biopharmaceutical manufacturers avoid unanticipated high production demands, and this generally requires having some excess, ‘flex’ or buffer capacity. But the cost of idle biomanufacturing facility capacity is best avoided. And current utilization rates (at least for mammalian cell culture) appear to be in a healthy equilibrium.


Today, even how we measure capacity and utilization may be changing dramatically. In the past, company and industry-wide capacity and utilization calculations have involved unit operations including fixed stainless steel bioreactor-anchored facilities used for most commercial manufacture, with most of this now decades old.


Yet, as single-use/disposable bioprocessing systems begin to dominate clinical scale manufacture, and creep into commercial scale, even our ability to define capacity utilization is being challenged. Capacity analyses in the future will need to use other metrics than simple liters of bioreactor space.


Capacity and utilization rates will become increasingly harder to estimate and may even become an irrelevant industry indicator in coming years, particularly as single-use equipment and modular facilities become adopted for commercial product manufacture.


Figure 1. Average Mab Titre 2008-2016, Commercial Scale


Source: 13th Annual Report and Survey of Biopharmaceutical Manufacturing, BioPlan Associates, Inc. April 2016, www.bioplanassociates.com/13th


Figure 2. Expected Future Capacity Constraints, by 2021; Biotherapeutic Developers vs. CMOs


Source: 13th Annual Report and Survey of Biopharmaceutical Manufacturing, April 2016, www.bioplanassociates.com/13th


Pharmaceutical Outsourcing | 28 | November/December 2016


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