A Project Approach for the Design, Construction, and Validation of Multi-Functional, Multi-Product, Pilot-Scale Biopharmaceutical Facilities

by Roshni Dutton, PhD and Geoff Sheffrin
Volume 3, Issue 6 (November/December 2004)


It has been reported that the biotechnology-derived medicines area of the pharmaceutical industry led to 133 marketed entities with sales of $22 billion by the year 2001. By 2002, the therapeutic protein market had reached $32 billion, with biologics representing more than 50 percent of all drugs approved by FDA — up from a modest 16 percent in 1995. The biopharmaceutical market is predicted to grow to $50 billion by 2008. Currently, approximately 40 percent of biopharmaceutical products are in Phase I and Phase II clinical trials. It is anticipated that from 2003 to 2008 there will be a more than 45-fold increase in demand for access to product development facilities capable of supplying clinical material…

Citation:
Dutton R, Sheffrin G. A Project Approach for the Design, Construction, and Validation of Multi-Functional, Multi-Product, Pilot-Scale Biopharmaceutical Facilities. BioProcess J, 2004; 3(6): 27-34.