The H1N1 pandemic is effectively a test of our preparedness for rapid response to new threats. So it is instructive to review how well the industry has been able to respond in this case. The results are not encouraging. As Prof. Peter Dunnill of the Department of Biochemical Engineering at University College London, notes in a recent article, "If you look at the situation, the amount of vaccine being produced globally is very small."1 The implication is that in the event that H1N1 becomes troublesome, then it is likely that commercial contracts will be broken by governments to ensure that supplies reach the population where the manufacturing capacity is based (most vaccine contracts include a clause allowing them to be broken under extraordinary circumstances, such as a health emergency). In addition, deliveries of vaccine are late and there are reports that deliveries are 50% lower than they should be.2
Thus, we see that in the current pandemic, it is taking months for manufacturing to respond, the overall capacity is insufficient for the world's population, and there are problems in ramping up production. It is against this backdrop that suppliers of disposables technologies are offering options.
In this article—the second of a two-part piece on rapid response—we consider the manufacturing component and the role of disposable technologies. In considering emergency preparedness, however, we need to consider the capability of producing not just vaccines but also therapeutic proteins. The US government is spending significant sums of money to encourage the building of manufacturing capacity in the US to meet short-to-medium term needs while also looking for innovative approaches to put in place truly rapid response manufacturing.3 The main catalyst for innovation is the accelerated manufacturing of pharmaceuticals (AMP) program, run by the US Department of Defense. The program is focused on developing new technologies that will revolutionize the manufacture of protein-based therapeutics. A key component to achieving the goals of this program is the use of disposable technologies in both process development and manufacturing. Yet, if we reflect on the conclusions of Part 1 of this article,4 there are a number of challenges relating to the current use of disposables:
None of these issues are addressed directly by the AMP program, but they do need to be addressed if we are to be truly flexible in terms of a rapid response.
- The disposables supply chain is immature and lacks flexibility to respond to rapid changes in demand. The lack of standardization among disposable suppliers considerably increases the supply chain risk, because in many cases, if a supplier cannot meet a deadline due to lack of available manufacturing capacity, or due to lack of availability of certain components, the vaccine or drug manufacturer cannot turn to an alternative supplier.
- There is a need to be able to deliver flexible manufacturing to where it is needed. How would this be achieved with disposables, which require an ongoing supply of consumables? Would disposables be stockpiled as a precaution for possible border closure?
- Standardization of disposable components is also needed to enable rapid reconfiguration of facilities to manufacture different products. There is currently a lag time, which can stretch several weeks whilst new components are qualified, as Tibor Nemes of Novartis emphasized in part 1.
- Better training is needed to help manufacturers understand how disposables make it possible to design facilities differently, enabling fully modular facilities working with standardized disposable systems throughout. Such facilities can be expanded rapidly with minimum effort to add capacity.
- The industry needs a better understanding of the infrastructure requirements that are needed when working with disposable technologies (as opposed to traditional systems) to support a rapid response.