Abstract

There is no abstract for this article. The text below is the first paragraph of text within the article.

Monoclonal antibodies (mAbs) have come of age as therapeutics. A strong argument can be made that mAbs are responsible for several of the most important advances in pharmacotherapy over the past decade. Agents such as Synagis® (palivizumab), Herceptin® (trastuzumab) and REMICADE® (infliximab) have transformed the treatment of infectious diseases, cancer and autoimmune diseases, respectively. Moreover, development pipelines are bulging with new opportunities. But, like adolescence, the maturing of mAb technology into a mainstream therapeutic platform is a turbulent time, one that is as fraught with uncertainty as it is with bravado. Simply put, mAbs are extremely expensive to manufacture and thus costly to patients and health care systems. Much of the expense is associated with the huge capital investment needed to build protein manufacturing facilities. Depending on their capacity, these facilities cost between $200 million and $1 billion. Moreover, the commitment to build such a facility must be made four to six years in advance if it is to be completed in time to support the launch of a new product. Put another way, this commitment must occur before a development candidate is in phase II clinical trials. The risk associated with this capital investment is so daunting that, understandably, many companies with promising mAbs in the pipeline have balked. As a result the industry could witness a threefold shortfall in manufacturing capacity over the next five years. This dearth of capacity will place additional pressure on the cost of mAbs.