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, firstname.lastname@example.org
. Miriam is also the European chair of ISPE's Community of Practice for Disposable Technologies.
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4. Sinclair A, Monge M. The disposables advisor. The role of disposables in rapid response manufacturing. BioPharm Int. 2009
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to Disposables. 2008 Nov;21(11) supp, p. 4–15.
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