Biotechnology assessment

Nowadays biocatalysis is a well-assessed methodology that has moved from the original status of academic curiosity to become a widely exploited technique for preparative-scale reactions, up to the point that the so-called industrial biotechnology (to which biocatalysis contributes to the most extent) is one of the three pillars of the modern sustainable chemistry. 

U.S. Congress, Office of Technology Assessment. Commercializing Biotechnology—An International Analysis. Washington, D.C. U.S. Government Printing Office, 1983. 

Kemppainen, A.J. Shonnard, D.R. (2005) Comparative Life-Cycle Assessments for Biomass-to-Ethanol Production from Different Regional Feedstocks. Biotechnology Progress, 21(4), 1075-1084. 

The mutual recognition procedure is an alternative means by which a marketing authorization may be sought. It is open to all drug types except products of biotechnology. Briefly, if this procedure is adopted by a sponsor, then the sponsor applies for a marketing licence not to the EMEA, but to a specific national regulatory authority (chosen by the sponsor). The national authority then has 210 days to assess the application. 

Taylor, S.L., Safety assessment of foods produced through agricultural biotechnology. Nutr. Rev., 61, S135-S140. 

Poulsen, L.K., Allergy assessment of foods or ingredients derived from biotechnology, gene-modified organisms, or novel foods. Mol. Nutr. Food Res., 48, 413, 2004. 

Biotechnological processes, life-cycle assessments for, 24 183 Biotechnology, 3 816 advances in, 13 330 application to agriculture, 13 283 in chemical transformations,... 

Doses should be selected that are reasonable multiples of the proposed therapeutic dose to be employed, especially since in many cases the amount of material available for testing may be limited and not available in Kg amounts. Preclinical rodent or primate studies should merely provide the flags to monitor during Phase I clinical trials. Reason should prevail, not only in the selection of methods and models for assessing the potential toxicity of the new agents, but also in the use of these data for extrapolation to humans. Whether U.S. industry succeeds or fails in the biotechnology arena will depend on the quick resolution of issues such as... 

Dorato, M.A. and Vodicnik, M.J. (2001). The toxicological assessment of pharmaceutical and biotechnology products. In Principles and Methods of Toxicology, (Hayes, A.W., Ed.). Taylor Francis, Philadelphia, PA. 

In a similar approach to that taken by the FDA, the International Food Biotechnology Council (IFBC) addressed issues associated with food and flavor ingredient production from GM materials and concluded that a reasonable safety assessment could be made by determining whether the ingredient had a prior history of safe use in approved foods and, if so, whether the GM substance was... 

G.S. Sayler and G. Stacey. 1986. Methods for Evaluation of Microorganism Properties. In Biotechnology Risk Assessment (J.R. Fiksel and V.T. Covello eds.) Pergamon Press, N.Y. 

OECD. 2003. Descriptions of Selected Key Generic Terms Used in Chemical Hazard/Risk Assessment. Joint Project with IPCS on the Harmonisation of Hazard/Risk Assessment Terminology. OECD Series on Testing and Assessment No. 44. Environment Directorate, Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology. ENV/JM/MONO (2003)15. Paris OECD. 

JRC is structured into seven institutes, one of these being the Institute for Health and Consumer Protection (IHCP). The IHCP activities are related to genetically modihed organisms, biotechnology, chemicals and risk assessment, nano-biotechnology, exposure to environmental stressors, food contact materials and consumer products, and alternative methods to animal testing (IHCP 2006). 

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