Eric S. Langer
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CMOs are on the leading edge of the growth of single-use devices. This growth is partly driven by their highly competitive
business model that requires that they continually drive for efficiency and productivity. As an example, today more than
86% of CMOs are using disposables/single-use devices to create improvements in bioprocessing performance, according BioPlan
Associates' 20th annual report (1). The survey asked 352 global biomanufacturers and CMOs which aspects of manufacturing technology
have improved performance at biologics facilities over the last year. Among the 15 areas identified, some significant differences
were seen between CMOs and biologics developers.
This year, the vast majority of CMOs, 86.2%, pointed to finding "significant" or "some" improvements as a result of single-use
devices adoption, far outstripping their next most popular factor, "improved upstream production operations," at 69%. By contrast,
62.8% of product manufacturers reported "significant" or "some" improvements from single-use devices usage—a healthy percentage,
but lagging behind factors such as "overall better control of process" (73.5% for biomanufacturers), "improved downstream
production operations" (68.9%) and "better process development" (68.4%), among others. The data, released in BioPlan Associates'
8th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, shows that implementation of single-use
devices was one of the few areas where CMOs reported implementing more performance improvements than product manufacturers.
UNITED STATES VERSUS EUROPE
Figure 1: Select factors in biomanufacturing performance creating "significant" or "some" improvements identified by biomanufacturers
versus CMOs. (ALL FIGURES ARE COURTESY OF THE AUTHOR)
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In comparing responses from manufacturers in the US, Western Europe, and the rest of the world (ROW), single-use device adoption
was one of the major areas with divergent responses, with more in Europe than the US and ROW reporting improvements from this
area. Specifically, 79.2% of Western European respondents signaled improvements derived from single-use devices, second only
to "overall better control of process," at 82.8% of European biomanufacturers. By contrast, 62.3% of US respondents and 55.2%
of ROW respondents reported improvements from single-use technologies, behind other factors such as improved production operations
(upstream and downstream), and process control enhancements. The Europeans' preference for single-use technologies may reflect
their customer purchases and/or vendor marketing catching up with those in the US, while much of the ROW still may not be
heavily implementing single-use systems, or vendors are simply not yet marketing heavily in these regions.
Taken together, 65.5% of biomanufacturing and CMO respondents pointed to benefits from usage of single-use devices this year,
a slight decrease from the 67.2% in 2010 (2). Indeed, this year, reported improvements from single-use devices dropped to
fourth on our list of factors, from second last year. This year, as in 2010, "overall better control of process" was the leading
factor creating performance improvements, with 72.6% of respondents (compared with 74.2% in 2010).
