Proteins as pharmaceuticals

Characterization and Bioanalytical Aspects of Recombinant Proteins as Pharmaceutical Drugs... 

As pharmaceutical scientists gain experience and tackle the primary challenges of developing stable parenteral formulations of proteins, the horizons continue to expand and novel delivery systems and alternative routes of administration are being sought. The interest in protein drug delivery is reflected by the wealth of literature that covers this topic [150-154]. Typically, protein therapeutics are prepared as sterile products for parenteral administration, but in the past several years, there has been increased interest in pulmonary, oral, transdermal, and controlled-release injectable formulations and many advances have been made. Some of the more promising recent developments are summarized in this section. 

An overall goal for these steps is to obtain a high yield while retaining the biological activity of the proteins. The required purity of the protein is determined by its end use. Enzymes that are to be used as technical catalysts require a lower purity than if they are to be used for analytic purposes or as pharmaceuticals. 

This chapter deals with fluorine-containing molecules that are currently clinically used as pharmaceuticals or are at an advanced stage of their development (i.e., registered by the administration or under clinical trials I, II, or III). These compounds are found in almost all therapeutic classes and stem from very diverse chemical families. In most cases, they are inhibitors of enzymes (anti-infectious, antitumor, antiviral drugs) or are ligands of various receptors (membraneous receptors coupled to protein G, ionic channels, or nuclear receptors). 

Akers MJ, Defelippis MR. Peptides and proteins as parenteral solutions. In Frokjaer S, Hovgaard L, eds. Pharmaceutical Formulation Development of Peptides and Proteins. (Pharmaceutical Science.) U.K. Taylor and Francis, 1999. 

The protein products from recombinant plant cells may be more functional and potent as pharmaceuticals than those from microbial origin because a post-translational modification is likely to occur in plant cells. 

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