Disposables in Rapid Response Manufacturing: The Next Steps - Suppliers, manufacturers, and governments must work together to plan how best to develop and deploy disposable systems for emergency respo


Disposables in Rapid Response Manufacturing: The Next Steps
Suppliers, manufacturers, and governments must work together to plan how best to develop and deploy disposable systems for emergency response.

BioPharm International
Volume 22, Issue 12


At a practical level, it is clear that rapid response can only be addressed by establishing facilities at strategic locations that could supply the main population centers. Short- to medium- term options should seek to establish some form of revenue-generating facility with the capability of expansion. Ideally, government and industry would collaborate at some level, whereby the response would be a measured one, and to encourage the establishment of this type of facility, regardless of who operates it.

In the near future, it is easy to imagine that suppliers will be in a position to supply the type of facility described above. If it is to work in the short term, however, compromises are required. First, because of the lack of standardization and interoperability among the systems and components offered by different suppliers, in the short term a facility may have to commit significant parts of its operation to one supplier.

Second, in the event of an emergency, two factors will affect the ability to ramp up production: the capacity of the supply chain to respond to increased demand and restrictions on the movement of people and materials. Therefore, manufacturers would need to stockpile all necessary disposable components (and other raw materials and specialist consumables) close to their key manufacturing centers.


At the moment, rapid response strategies and approaches are being developed by governments and interested parties, but we do not have a coherent approach. The goal is to establish meaningful strategies for protecting the population in a pandemic. At the policy level, it is important that we have clear definitions of the scenarios that we want to protect against. These scenarious also must be tested in terms of whether they are real threats rather than "what if" threats; "what if" threats are easy to formulate but are often used as a form of scaremongering. We then have to be realistic when considering how governments will behave when responding to real and tangible threats. If we take all this into consideration, then it is possible to build a viable plan for a staged manufacturing response to a threat.

Disposable manufacturing technologies will be key to delivering that staged response, but much work needs to be done by the industry and governments to transform this into reality. At the moment, we see developments within the supplier base to provide the disposable manufacturing systems required, but this is only part of the solution. Suppliers, manufacturers, and governments need work together to consider how best to develop and deploy disposable systems in the event of an emergency.

Andrew Sinclair is the managing director and Miriam Monge is the vice president of marketing and disposables implementation, both at Biopharm Services, Chesham, Bucks, UK, +44 1494 793 243,
. Miriam is also the European chair of ISPE's Community of Practice for Disposable Technologies.


1. Doubts surface over UK swine flu vaccine supply. Times Online. 2009 July 17 [cited Sept. 16, 2009]. Available from http://www.timesonline.co.uk/tol/life_and_style/health/article6718224.ece/

2. Jack A. Baxter behind on swine flu vaccines for Britain. Financial Times [online]. 2009 Sept 10 [cited 16 Jan. 2009]. Available from: http://www.ft.com/cms/s/0/c3ba0932-9da0-11de-9f4a-00144feabdc0.html

3. Defense Sciences Office [homepage on the Internet]. Accelerated Manufacture of Pharmaceuticals. Available from: http://www.darpa.mil/dso/thrusts/bwd/act/amp/index.htm

4. Sinclair A, Monge M. The disposables advisor. The role of disposables in rapid response manufacturing. BioPharm Int. 2009 Aug;22(8): 28–31.

5. Sinclair A, Leveen L, Monge M, Lim J, Cox S. The environmental impact of disposable technologies. BioPharm Int. Guide to Disposables. 2008 Nov;21(11) supp, p. 4–15.

6. Xcellerex [homepage on the Internet; cited 2009 Sept]. Available from: http://www.xcellerex.com/

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