Compiled ByDave Schafer A steady increase in biotechnology-based drugs has pushed biopharmaceutical-contract manufacturers to 90% capacity utilization rates and is forcing pharmaceutical, biotechnology, and contractor companies to refigure manufacturing strategies, a new study says. In the past, the primary risk for these companies was over-building, says Moraga, Calif.-based HighTech Business Decisions, the pharmaceutical, biotechnology, and electronics-industry consulting company that published the survey. Several companies built facilities for therapeutics that in the end did not win FDA approval and therefore could not be sold. Now, with more than 100 biotechnology-based drugs on the U.S. market and hundreds more in the pipeline, there is a risk of under-building, HighTech says. "Without enough capacity, a company with a newly approved biotechnology product may lose millions of dollars in sales and lose a market advantage to competitive forces," says Sandra J. Fox, president, HighTech. "Even those companies with in-house capacity may still not meet the needs of blockbuster drugs that are prescribed in high doses for chronic diseases. Some products may be dropped from a commercialization path because of the lack of capacity and never reach the market." To solve the capacity crunch, HighTech says many pharmaceutical and biotechnology companies are forming new manufacturing strategies that involve building in-house capacity while also forging relationships and long-term commitments with contract biomanufacturers. Some are investigating alternative manufacturing technologies, such as transgenic production, for products requiring high-volume capacity. More than 89% of the contractors surveyed are planning expansions to meet the increasing demand for capacity.