ABSTRACT
The use of therapeutic proteins to replace or supplement endogenous protein molecules has been a long established treatment for diseases such as diabetes, growth hormone deciency, and hemophilia. More recently, an increasing number of pharmaceutical products comprise proteins and peptides. A total of 165 biopharmaceuticals were approved as of 2006 with $33 billion in sales. An increasing number of biopharmaceuticals are approved by the FDA each year. Protein and peptide drugs are either natural in origin or synthetically produced using recombinant DNA technology or from transgenic animals. Recombinant DNA technology has allowed the large-scale production and biological characterization of several therapeutic proteins, including granulocyte macrophage colony stimulating factor (GM-CSF), erythropoietin (EPO), interleukins, insulin-like growth factor-1 (IGF-1), human factors VIII and IX (involved in blood coagulation and useful for hemophilia), and tissue plasminogen activator (t-PA). Table 22.1 lists some of the FDA approved marketed products of therapeutic proteins.
