CAPACITY UTILIZATION TRENDS
Although outsourcing of traditional expression systems has remained fairly steady in BioPlan's preliminary data, capacity
utilization may be trending upward after several years of decline. Capacity utilization is important for ensuring productivity
and cost-effective operations. Lower utilization equates to more idle capacity. A certain amount of flexible capacity is needed
to ensure availability during stress operations. Also, CMOs require open capacity to ensure they are not turning away potential
clients. Conversely, too little capacity can lead to production and delivery problems. Ten years ago, capacity utilization
was a more prominent issue. Today, increased yield of titers, improved bioproduction modeling, the use of disposables, and
better planning have lifted most capacity problems.
Manufacturers, however, continue to work toward optimized upstream and downstream process operations. In upstream bioprocessing,
mammalian cell-culture capacity in 2013 is averaging 65.4% of total capacity, which would be its highest level since 2006,
according to BioPlan's preliminary data. Capacity use has stabilized at roughly 62% during the past six years after declining
from 76.4% in 2004.
Meanwhile, the rebound is even greater for microbial fermentation. After decreasing steadily from 71% in 2004 to 49.5% in
2012, capacity utilization appears to have increased to 62% this year, quite a significant change. For yeast culture, the
initial data showing 48.4% capacity utilization represent an uptick from 2012 level of 35.7%, but is more in keeping with
prior years, which ranged from 44.9% to 46.8% between 2006 and 2011. Capacity utilization for plant- and insect-cell systems
remains steady comparative to 2012, but noting again the potential for "noisy" data due to the small number of respondents
using these systems.
For essentially all expression systems, there appears to be underutilized capacity, which is preferable for companies and
the industry when compared to the alternative, a shortage of capacity. Despite utilization percentages having decreased in
recent years, new capacity and higher yields were established during this period, so overall biomanufacturing levels (i.e.,
output) have risen considerably.
Despite steady utilization rates in insect- and plant-cell expression systems, outsourcing appears to be rising. For traditional
mammalian and microbial expression systems, capacity utilization rates are trending upward while outsourcing has remained
flatter. On the surface, capacity utilization and outsourcing would appear to be interconnected— when capacity is scarce,
outsourcing becomes an option. For many bioprocessing technologies, however, selection factors may be more associated with
the availability of technical competence among outsourcing suppliers and CMOs rather than simply access to available production
Eric S. Langer is president and managing partner of BioPlan Associates, firstname.lastname@example.org