Manufacturing Biological Clinical Materials by a Dual Track "Traditional/Transgenic" Approach

by Brandon J. Price, PhD
Volume 1, Issue 2 (Summer 2002)

By virtually any measure, constraints in current manufacturing capacity are hindering the development of new biologic drugs, as well as the greater market penetration of several licensed biologics. This capacity demand is being driven not only by the increasing number of new biologics being approved, but by the number of biologics that are in the product development pipeline. Figure 1 shows United States FDA biologics approvals for the 20-year period from 1981-2000. While there is year-to-year variability in approvals, especially in later years, the five-year averages show a doubling in the annual rate of product approval for each successive five-year period. Clearly, these averages cannot continue to increase at the same rate. In fact, only six biologics were approved by the FDA in 2001...

Price BJ. Manufacturing Biological Clinical Materials by a Dual Track "Traditional/Transgenic" Approach. BioProcess J, 2002; 1(2): 30-35.