There are many recognized benefits from the use of disposables, many of which can shorten lead-time to get a facility or campaign
up and running. CMOs can be the first to reap these advantages, but all biomanufacturers have seen benefits. The top five
reasons most commonly cited by all respondents as "most critical" include:
1. Reduce capital investment in facility and equipment (21% for 2011, up from 14.4% in 2009)
2. Eliminate cleaning requirements (12.6%)
3. Faster campaign turnaround (11.2%, up from 6.9% in 2009)
4. Decrease risk of product cross-contamination (8.4%)
5. Reduce time to get facility up and running (6.3%).
It is clear that single-use devices continue to gain acceptance in the industry, and that their benefits are being increasingly
noticed. Over time, we expect biomanufacturers and CMOs to integrate disposables into most processes, especially as downstream
single-use solutions and specific devices such as probes and sensors continue to evolve. In addition, as new regions such
as China and India gain prominence and begin to produce biologics and biogenerics, the need for consistent quality will likely
dictate the greater use of disposables, because they can often be implemented more efficiently and with fewer risks of quality
problems (4). As new biomanufacturers enter the industry and new products enter the pipeline, the disposables option will
become part of the decision process from the very start.
Eric S. Langer is president and managing partner at BioPlan Associates and a member of BioPharm International's editorial advisory board.
1. BioPlan Associates, "8th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production: A Survey
of Biotherapeutic Developers and Contract Manufacturing Organizations" (April 2011).
2. BioPlan Associates, "7th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production: Survey of
Biotherapeutic Developers and Contract Manufacturing Organizations" (April 2010).
3. CMC Biologics, "CMC Biologics Adds 2,000 Liter Single-Use Bioreactor at its Copenhagen Manufacturing Facility," press
release, (Copenhagen, Denmark, Sept. 1, 2011).
4. BioPlan's Top 1000 Global Biopharmaceutical Facilities Index,
http://www.top1000bio.com/index.asp, accessed Aug. 20, 2011