Laura Bush
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There have been several exciting developments in recent weeks related to vaccine manufacturing. Sanofi-Aventis announced a
€100 million investment in a new plant in Mexico, where it will manufacture flu vaccines in collaboration with the Mexican
firm Birmex. The University of Pittsburgh Medical Center (UPMC), meanwhile, has plans to develop a flexible facility that
can respond quickly to manufacture vaccines against bioterrorism. GE Healthcare, Merck & Co, IBM, and Batelle are all partnering
on the project, which will be operated by the university's non-profit 21st Century Biodefense organization.
The developments of the recent H1N1 outbreak, however, remind us that vaccine production is a far cry from the platformed
process that monoclonal antibody production has become, and that we still have a long way to go in terms of preparedness for
pandemics and bioterrorism. The H1N1 virus was more difficult to grow than expected, leading to delays in production; by the
time large quantities were ready, the virus's spread had lessened, easing the public's fears and lowering demand for the vaccine.
Meanwhile, many developing countries did not receive as much vaccine as they wanted. The stability of the formulations also
posed problems, with several companies forced to recall various lots.
All of this has made some governments rethink their preparedness strategies. Canada, for example, had opted for single-sourcing
from GSK, the only firm with flu vaccine manufacturing facilities in Canada. That approach was based on fears that international
borders would close in a pandemic. Borders stayed open during H1N1, however, so after experiencing delays from its only supplier,
the government now plans to sign contracts with multiple companies.
On the positive side, many companies are continuing to pursue solutions. For example, several companies are pursuing universal
flu vaccines, and one of them, BiondVax, just received positive results from a Phase 1–2 trial. If successful, this approach
would eliminate the need to respond quickly to new flu strains and free up resources to address other pandemic or bioterrorism
threats. Meanwhile, equipment and technology suppliers like GE Healthcare and Xcellerex continue to focus on applying single-use
technologies to rapid scale-up and commissioning, in partnership with organizations like UPMC, and others, like Novavax, whose
virus-like particle technology enabled it to produce H1N1 vaccine in less than four weeks after the strain was identified.
The initial excitement—and panic—of H1N1 are long gone, and thankfully so. That means now is a good time for manufacturers
to assess what the outbreak taught us and use that information to plan for the next one; at least one major manufacturer is
doing exactly that right now. For our own analysis of what happened with H1N1 and the outlook for future pandemic response,
we recently turned to John Hyde of Hyde Engineering & Consulting. You can watch that interview, recorded live at the Interphex
Main Stage, at
http://www.biopharminternational.com/Interphex2010.
We all know that experience is the best teacher, and I for one am grateful that H1N1 gave us the opportunity to learn without
taking an enormous toll in the process. Now, let's take advantage of that lesson.
Laura Bush is the editor in chief of BioPharm International, lbush@advanstar.com
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