Pharma Outsourcing

LIKE MOST INDUSTRIES, the pharmaceutical industry is becoming more and more global with each passing year. Yet much of the world's basic drug discovery know-how still resides in the U.S., and much of that is in the hands of biopharmaceutical companies started by entrepreneurial scientists.

When these small firms are ready to test their potential drugs for safety and effectiveness, they need more than the test-tube quantities they have been synthesizing or fermenting in the lab. Most of them don't have the facilities or expertise to manufacture under the current Good Manufacturing Practice standards required by the Food & Drug Administration for clinical trials.

That's when biopharmaceutical companies must turn to third-party contract manufacturers. When they do, they find that the know-how is not confined to U.S. shores. Many of the most experienced service providers, in fact, are based in Europe, the historic cradle of the drug industry.

In the pages that follow, C&EN presents three case studies of the relationship between a U.S. biotech firm and its custom manufacturing partner. In the first case, a California company strikes a unique deal with a Swiss contractor in which it takes over a drug-tableting plant in Switzerland. It makes pills for the Swiss firm and, in exchange, hires the Swiss firm to make its active pharmaceutical ingredient.

In the second case, a California firm decides to stay local. With the aid of a Syracuse, N.Y.-based consulting company, the biotech finds a diversified chemical company that can meet its needs with a process development facility in Louisiana and a pharmaceutical actives plant in Michigan.

The third story concerns a virtual biotech firm run out of a cancer institute in Buffalo. It has discovered a protein-based drug with the potential to shield soldiers against radiation poisoning. Although the company considered U.S.-based contract manufacturers to scale up supplies of its molecule, it ultimately turned to a small firm in the Netherlands.

Drug discovery is a risky enterprise, and only time will tell whether FDA will give its nod to any of the compounds profiled. But as these three stories show, scientists and businesspeople in biotech companies are willing to search around the world for the partners that are most likely to bring their discoveries to market.

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