Biotechnological pharmaceuticals challenges

The early membranologists have always been optimistic about the possibilities of membrane operations, but the scientific and technical results reached today are even superior to the expectation. A variety of technical challenges must be overcome to permit the successful industrial apphcation of new membrane solutions. Chapter 43, on the same theme, presents the future scenario of membrane processes covering chemical, biotechnological, pharmaceutical applications, etc., and also focusing fumre progresses in membrane engineering. 

Hemenway, J.N. (2007) Prodrugs Awards and Challenges (Biotechnology. Pharmaceutical Aspects) (ed. V. Stella, R. 

The development of the biotechnology industry presents new and novel molecules derived from nature. The utilization of these molecules as pharmaceutical products presents an analytical challenge of a magnitude greater than ever confronted. The drug candidate and closely-related molecules have... 

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). 

The issue of product comparability when manufacturing processes or systems are changed, in particular, poses an important challenge to the pharmaceutical and biotechnology industry. For example, how should a sponsor demonstrate that proteins secreted into the milk of transgenic cattle or goats... 

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