Pandemic Flu Preparedness: A Manufacturing Perspective - Scalability, speed, and biosafety will be critical in the event of an influenza pandemic. The containment needs of an avian flu strain could pr

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Pandemic Flu Preparedness: A Manufacturing Perspective
Scalability, speed, and biosafety will be critical in the event of an influenza pandemic. The containment needs of an avian flu strain could present additional challenges.


BioPharm International


ABSTRACT

In today's seasonal influenza market, vaccine manufacturers must match supply to a conservatively estimated annual demand; this estimate is typically lower than what is needed, and so it can represent lost profits. The threat of an influenza pandemic presents an unprecedented vaccine manufacturing situation in which scalability, speed, and biosafety would be key issues. An avian flu strain could mean additional biocontainment challenges. Hence, alternative technologies are being developed to address the drawbacks of traditional platforms. The ideal vaccine manufacturing facility would handle multiproduct campaigns and would include a range of production and process platforms. Vaccine manufacturers should consider how to make a good business case for new production and facility concepts.



The increasing attractiveness of the influenza vaccine market, with its high-growth potential, is proving to be a key driver in planning and building new vaccine manufacturing facilities. The interest in new facilities is heightened by international initiatives focused on the need for ramped-up vaccine production in the event of a World Health Organization (WHO) pandemic Phase 6 declaration. (Phase 6 is a red alert signalling increased and sustained transmission of a virus in the general population, following previous confirmation of the onset of a pandemic [Phases 1, 2, and 3], in localized small clusters [Phase 4], and continuing toward limited transmission across larger clusters [Phase 5]). Although in the short term, new facilities could provide vaccine manufacturers with "the best equipped can best respond" strategies towards pandemic preparedness, the long-term commercial advantages of multipurpose facilities should be evaluated for return on investment and mitigation of financial risks.

Influenza Vaccine Market: Demand Versus Supply

The seasonal influenza industry of today can be viewed as the result of an imperfect market. Manufacturers match supply to a conservatively estimated demand for seasonal flu vaccines annually; this estimated demand is far lower than what would prevent or reduce related mortalities, and it results in lost economic productivity. Often seen as fickle, this low estimated seasonal influenza demand has not offered vaccine manufacturers the incentives to develop more efficient processes, and as the consequence of an underfunded market, it has resulted in a manufacturing system based on an antiquated process. This situation is now changing. Because it is expected that seasonal flu facilities will be modified to manufacture pandemic vaccines in a time of crisis, manufacturers' ability to deliver is belied by a global capacity shortfall. This shortfall will occur because the market size for a pandemic vaccine is potentially the entire world population. If represented as the "global influenza superset," this market has little or no relationship to current seasonal demand, yet it is wholly dependent on the supplies of "local subsets" of seasonal flu resources. Currently available capacities would be insufficient in a pandemic crisis, and new investments are driven toward building seasonal influenza manufacturing facilities. However, the key issue being raised is whether there is a good economic case for these new facilities, especially in markets with little or no demand for seasonal vaccines.


Table 1. The US influenza market overview
The US influenza market (Table 1) illustrates the "current pandemic shortfall–projected seasonal surplus" scenario. This model, when applied to the rest of the world, especially to the latent seasonal vaccines industry in developing countries, shows that the "current shortfall–future surplus" gap is even wider than might be expected. Manufacturers must, therefore, consider a different approach and question whether the surplus capacities planned for preparedness can be used for other programs.


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