Biotechnology, problems with protein

Bioteehnology produets differ in their method of preparation and potential problems they present in their formulation. Pharmacists involved in compounding with biologically active proteins are interested in their stabilization, formulation, and delivery. Most of the current biotechnology products are proteins, but soon some may be smaller peptide-like molecules. 

In the biotechnology industry focused on producing monoclonal antibodies and therapeutic proteins, the problem of protein aggregation is ubiquitous. This is dealt with in detail in Chapter 20 and in Section 14.1. 

Since risk analysis plays an important role in public policy decision making, efforts have been made to devise a means by which to identify, control, and communicate the risks imposed by agricultural biotechnology. A paradigm of environmental risk assessment was first introduced in the United States by Peterson and Arntzen in 2004. In this risk assessment, a number of assumptions and uncertainties were considered and presented. These include (1) problem formulation, (2) hazard identihcation, (3) dose-response relationships, (4) exposure assessment, and (5) risk characterization. Risk assessment of plant-made pharmaceuticals must be reviewed on a case-by-case basis because the plants used to produce proteins each have different risks associated with them. Many plant-derived biopharmaceuticals will challenge our ability to define an environmental hazard (Howard and Donnelly, 2004). For example, the expression of a bovine-specihc antigen produced in a potato plant and used orally in veterinary medicine would have a dramatically different set of criteria for assessment of risk than, as another example, the expression of a neutralizing nonspecihc oral antibody developed in maize to suppress Campylobacter jejuni in chickens (Peterson and Arntzen, 2004 Kirk et al., 2005). 

---