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executive vice president of Co. a 50-employee contractor in Grafton, Wis., explains that the typical emerging company has a big drug discovery effort, some process development capability, and very little manufacturing, quality control, quality assurance, or analytical expertise. "Their needs are different from major pharma," he says. "They outsource many activities that the majors do internally." Companies like Title Co. often provide regulatory expertise, quality assurance, and even the assembly of the chemistry, manufacturing, and controls sections for investigational new drug (IND) and new drug application (NDA) submissions to the Food & Drug Administration. Both Executives are both former Amoco employees who got the idea for their company while working in Amoco's new ventures unit. They had wanted to outsource production of a compound, and found very little competent pilot-scale capacity in the U.S. that complied with current Good Manufacturing Practices (cGMP) standards.
THEY BROKE GROUND on a facility in Grafton in July 1997, and by June 1998 they were operating a pilot plant and process development facility. Today, the company is the contract manufacturer of active pharmaceutical ingredients (APIs) for five commercial drugs and for multiple APIs in all stages of clinical trials. Boland says its customer base is roughly 70% emerging companies, 20% major pharma, and 10% generics firms. He acknowledges that the larger companies are starting to compete more actively for emerging company business but says Co. is holding its own, including winning out on projects in competition with much bigger firms. Working in its favor, executive says, is a track record with difficult chemistry, successful cGMP production and FDA inspections, and an entrepreneurial culture similar to that of the small companies it generally serves. "Because Co. is the size it is, we can be much more responsive to customer needs," he says
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