Protein Drugs: Global Markets and Manufacturing Technologies

STUDY GOALS AND OBJECTIVES

Protein drugs have received enormous attention from pharmaceutical companies due to a combination of their bioreactivity, specificity, safety and overall success rate. Yet there are still improvements to be made, especially with respect to their formulation and delivery method. Advances in protein drug delivery are certain to increase patient compliance and expand many drug markets.

REASONS FOR DOING THE STUDY

Although the drug development industry still focuses primarily on small molecules, in recent years protein and peptide therapeutics comprise a significant percent of the product line and pipeline for most major pharmaceutical companies. Peptide and protein therapeutics, especially antibody drugs, are attractive due to their high specificity and potency and low incidence of toxicity. Developments in manufacturing, including transgenic, recombinant and synthetic methods, have been key as protein drugs have moved into the mainstream. A previous report by BCC, Protein Drugs in 2003, discussed the early days of these manufacturing improvements and focused on emerging recombinant methods of protein production.

Recombinant protein technologies are now standard and the current focus has shifted from the method of bulk production to post-production techniques that promise to enhance stability and delivery. In the effort to produce orally available therapeutics, formulation issues have become critical.