ABSTRACT

Many biotech companies have elected to follow the approach of large, traditional pharmaceutical manufacturers and build dedicated facilities for the manufacture of a single product. While this approach has obvious advantages related to inventory control, staffing, and regulatory compliance, it can put a tremendous financial burden on young companies with numerous products in the clinical development pipeline and a limited cash flow to support capital expenditures. It also limits both the company’s ability to respond to the continually changing needs of the healthcare industry and advances in its own product research and development.