ABSTRACT
Advances in biotechnology have resulted in a signicant increase in the number of therapeutic peptides and proteins that are reaching the market. This trend is expected to continue and escalate in the future. Applications of biotechnology are not limited to pharmaceuticals; they extend to agriculture, food processing, and chemicals, among others. However, the most signicant activity to date has been in human health care, both therapeutics and diagnostics (Assenberg, Wan, Geisse, & Mayr, 2013; Montague, 1992; Sterling, 1990; Wordell, 1992). Although a detailed discussion of biotechnology is not within the scope of this book, this chapter provides a very brief overview of some of the principles of biotechnology that can be critical in the formulation and delivery of peptides and proteins. For example, the presence of host-cell protein (HCP) as impurity in the nal product may be responsible for stability or immunogenicity problems of a formulation. Two things need to be pointed out here. First, biotechnology principles go beyond the production of proteins by recombinant DNA (rDNA) technology. For example, antisense agents are oligonucleotides, not proteins. Similarly, gene therapy is of direct benet to the patient but does not involve the development of a drug as conventionally understood. Some of the biotechnology principles and products are briey reviewed in this chapter, but the focus of this book in the remaining chapters is on the formulation and delivery of therapeutic peptides and proteins. Second, it must be realized that the basic concepts of formulation and delivery of these drugs are applicable to any peptide or protein, whether of biotechnology origin or not.
