Chromatographic Analysis of Therapeutic Proteins

Abstract

J v_Analysis of __/ v. Therapeutic ProteinsDevelopment of new pharmaceuticals is increasingly expensive. Not only are the costs of R&D, laboratory testing, clinical trials, administration. and overhead escalating, but the maturing of the pharmaceutical industry itself is adding to the burden. Ten years ago. the rule of thumb was that development of a new drug cost about $200 million. Today that figure has doubled. A drug patent gives its owner exclusive rights to the invention for 17 years. Because it often takes as many as 12 years to bring a drug to market, it is crucial that product development proceed as efficiently as possible. Today the general rule for evaluating return on investment for pharmaceutical products is that for each day's delay in bringing the product to market, $1 million in sales is lost.Analysis and purification are essential parts of drug R&D, manufacturing, and quality assurance. Using rapid analytical methods can significantly cut develop-