SCALING UP
Most collaborative projects rely on an industry partner to handle manufacturing and packaging of final drug products. Smaller
biotech firms are likely to outsource manufacturing to a larger organization or developing-country partner. Those may include
fairly sophisticated generics firms in India, China, and South Africa that have considerable expertise in formulation chemistry,
low-cost scale up, and product distribution in Africa and Asia; some larger generic manufacturers are also gaining expertise
in biotechnology formulation and production.
The search for effective disease treatments also may yield more-efficient and innovative formulations and manufacturing approaches.
For example, iOWH is partnering with researchers at the University of California, Berkeley, and a spin-off company, Amyris
Biotechnologies, to develop a large-scale, low-cost commercial microbial drug production process for artemisinin, the key
ingredient in new antimalarials.
"Manufacturability" is an important consideration for identifying potentially successful products, says Jerald Sadoff, president
of the AERAS Global Tuberculosis Vaccine Foundation (Rockville, MD,
http://www.aeras.org/), formerly with Merck. Most projects fail because they can't be made at an acceptable cost or in a reliable way for millions
and millions of doses. Based on expectations that its R&D portfolio will yield effective vaccines in the coming decade, AERAS
has built a $10 million research and manufacturing facility in Maryland. This investment permits AERAS to produce candidate
vaccines that meet good manufacturing practices standards for use in clinical trials. Sadoff acknowledges that a new vaccine
may not be available for widespread use until 2012, but believes that these early efforts set the stage for scaling up to
produce the 150 million doses or more needed every year for a successful product.
PUSH FOR FUNDING
The limiting factor on all these initiatives is inadequate funding from wealthy nations. The Moran report notes that more
than half the nearly $255 million contributed to PPPs as of April 2005 came from the Gates Foundation; the US provided $16
million, much more than other governments, but still very little. Most of public funding for third-world health currently
goes to treatment programs such as the Global Fund to Fight AIDS, Tuberculosis, and Malaria and the President's Emergency
Plan for AIDS Relief (PEPFAR). These programs can "pull" new drugs to market, but have not stimulated new research on less
visible diseases.
Jill Wechsler is BioPharm International's Washington editor, 7715 Rocton Avenue, Chevy Chase, MD 20815, 301.656.4634, jwechsler@advanstar.com
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