Success in new vaccine development, however, presents new challenges regarding global distribution and access. While vaccination
may be the most cost-effective approach for improving worldwide health, the emergence of more effective preventives for a
broader number of diseases raises questions about who will pay, who will control distribution, and whether multiple vaccinations
raise unknown safety issues. Most vaccine manufacturing takes place in Europe and the US where companies are most likely to
provide products first in the case of disease outbreak. Indonesian health officials have raised the issue in demanding access
to vaccines developed with the help of bird flu viral samples collected from their sick patients.
To address this issue, the World Health Organization is working with donor nations (WHO) and manufacturers to expand vaccine
production capacity globally and possibly establish a third-world vaccine stockpile. WHO awarded grants in April 2007 to build
influenza vaccine manufacturing capacity in Brazil, India, Mexico, Thailand, VietNam, and Indonesia.
These efforts would gain from the development of adaptable, disposable biomanufacturing technologies. Biotech manufacturing
facilities normally take years to establish and validate and are not amendable to quick response and diverse production. Now
equipment makers are designing new systems that can be deployed rapidly, are less costly to build, and require less water
and power to operate. Such biotech production systems are being developed now with larger production capacity, noted Parish
Galliher, president of Xcellerex, which has a line of portable bioreactors with disposable single-use components for producing
clinical supplies and a variety of biotherapeutics and vaccines. Many vendors are developing similar systems that can be used
for multiple purposes. Germany-based Sartorius is working with Thermo Fisher-Scientific to produce disposable process containers
for biopharmaceutical applications.
Government research programs, such as the Defense Advanced Research Project Agency (DARPA), supports an accelerated manufacturing
of pharmaceutical (AMP) program, which seeks to develop rapid, flexible vaccine manufacturing systems. The goal is to establish
a protein manufacturing platform able to produce 3 million doses in 12 weeks, which also would help provide low-cost drugs
for the developing world. Similarly, the National Institute of Allergy and Infectious Diseases (NIAID) has established a process
development section in its malaria vaccine development branch that is working on new methods for fermentation, purification,
and scale up.
OPPORTUNITIES AND RISKS
Such developments are attracting interest from the financial community. Investment company Kleiner Perkins Caulfield & Byers
(KPCB) has established a Pandemic & Bio-Defense Fund with $200 million invested in companies developing rapid deployment biological
manufacturing systems, as well as new disease surveillance systems, portable diagnostics and broad-spectrum therapeutics,
and multivalent vaccines. Pharmaceutical companies are looking for acquisitions and investment opportunities. Glaxo has purchased
some small vaccine firms, while Novartis picked up troubled Chiron following its flu vaccine debacle in 2004. More recently
AstraZeneca paid a premium price for MedImmune, which is expanding the market for its FluMist inhaled vaccine.
While vaccine R&D may be in the limelight, the risks continue to rear up. MedImmune has run into trouble with FDA over manufacturing
violations for FluMist. FDA has raised safety concerns about Dendreon's new cancer vaccine Provenge, and additional analysis
will delay approval of this potential treatment for prostate cancer at least another year. Many test products may never make
it to market, but those that do may offer significant improvements in public health.
Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634, firstname.lastname@example.org