ABSTRACT

INTRODUCTION Since the early 1970s, scientific advances in molecular biology and genetic engineering have led to enormous success in protein-and peptide-based therapeutics for the treatment of many human diseases. They cover almost all therapeutic categories, including cardiovascular hemostasis, antineoplastic, diabetes and endocrinology, anti-infective, neuropharmacological, enzyme replacement, wound healing, respiratory, and bone cartilage. Protein-based therapeutics are emerging as a major class of new molecular entities in the pharmaceutical industry. Over 200 biotechnology and pharmaceutical companies are developing protein-based therapeutics. More than 150 biologics are currently marketed, and over 400 are in advanced stages of testing and clinical trials (1).