BioCentury
ARTICLE | Strategy

Making the 'make' decision

April 19, 2004 7:00 AM UTC

Drug discovery and development is like the portion of an iceberg that is above water: visible and dramatic. Manufacturing is like the portion that is under water: out of sight and often out of mind. Yet the cost for process development and building a full-scale commercial facility can approach the cost of developing a drug. And companies ignore manufacturing at their peril: about half of FDA problems with applications for marketing approval are related to manufacturing.

Thus a wrong decision about manufacturing can be immensely costly. Perhaps the best recent example comes from Immunex Corp., which was acquired by Amgen Inc. in December 2001. Immunex and partner Wyeth (WYE,Madison, N.J.) lost incalculable sales when they failed to build enough capacity to match demand for their Enbrel etanercept drug for rheumatoid arthritis. ...