Safety Issues Specific to Clinical Development of Protein Therapeutics

Discoveries in molecular sciences have advanced research into therapeutics that target an array of newly identified ligands and receptors with the hope of meeting critical needs of patients with chronic or life-threatening diseases. Protein or biologic therapeutics include peptides, endogenous proteins, monoclonal antibodies, hybrids such as Fc construct molecules (including peptibodies and soluble receptors), and avimers. Proteins may be purified animal derivatives, fully human, or have portions of animal and human proteins engineered together into chimeric and humanized monoclonal antibodies. Although some reports distinguish therapeutic proteins from monoclonal antibodies, for the purposes of this article the terms biologics and proteins are used interchangeably.