COUNTRIES WITH NO MANUFACTURING CAPACITY
Currently, much of the manufacturing capacity for flu vaccines is located in the West, as well as in India and China. So
what about countries that do not have capacity in place? "The theory of inserting a facility into different geographic zones
just like that and being able to manufacture rapidly is not at all realistic in my opinion," says Nemes, citing the need to
consider the regulatory aspects. "We have a pandemic situation now but you must assure GMP compliance and licensure of a facility
to protect patients." Therefore, he says, these regions need to build capacity in advance, so that they can switch over rapidly
to new products when needed.
For such situations, Galliher says Xcellerex FlexFactory is an option. "The FlexFactory can be delivered to government-funded
vaccine research institutions that have the know-how but not the ability to manufacture on a large scale," he says. Such plants
would initially be used to manufacture other vaccines with the possibility of changing over quickly in the case of a pandemic.
Galliher adds that another key benefit of disposable technology is that it is less complicated to operate. "You can train
people more quickly so you don't need as much education because of the reduced complexity," he says.
Jagschies points out that Asian nations have made some good steps toward pandemic preparedness. India hosts the world's largest
vaccine manufacturer, the Indian Serum Institute, and some of the smaller Indian contract manufacturing organizations (CMOs)
are backed up by large European CMOs. In Korea, there is a CMO (Celltrion) established to Western standards. "If these organizations
were to collaborate with the national institutions around preparedness, this infrastructure could be effectively used in a
pandemic," he says. "Collaboration between the private sector and government could be possible."
Disposable technologies are playing a role in the current response to H1N1, but they are not the complete answer. There has
been much discussion of disposable technologies' ability to deliver rapid changeover of manufacturing from one product to
another, but this is not necessarily easy, given the lack of standardization of disposable technologies. From the logistics
perspective, we need to have in place a mature, robust supply chain that can respond to a rapid increase in demand, and we
must keep these factories supplied with components and materials required for an emergency. And strategies are required to
help countries that don't readily have access to manufacturing capacity so that they can respond to a pandemic.
In this article, we have focused on the general issues around disposables and how they support reponses to a pandemic. In
Part 2, we will consider further the future manufacturing challenges based on disposables for rapid response, the options,
including the implications, and the industries' 5- to 10-year view on this. Specifically, we will look at what end-users and
suppliers of disposable technologies believe needs to be done so that disposable technologies can play a more effective role
in rapid response manufacturing.
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.
* The opinions expressed in this article are solely those of the individual and may not necessarily represent the opinion
or position of Novartis.
http://Novartis.com/ [homepage on the Internet]. Novartis successfully demonstrates capabilities of cell-based technology for production of A(H1N1)
vaccine. Available from: