Genetically modified microorganisms (GMM) are widely applied in research, medicine, pharmaceutical and food industries, as well as in agriculture and environment protection. The assessment of actual risk to human health and to environment related to GMM application is often difficult, because these is unsufficient experience in the application of GMM in areas other than research. That is why European Union, as well as Poland, have undertaken several activities serving to prevent any harm to human health and/or to environment, which might result from utilization of genetic engineering. These activities are performed on the level of legislation and on the level of research programs, aiming at the establishment of effective methods of GMM containment and control. Polish law on Genetically Modified Organisms from 22 June 2001 builds the safety system in Poland in accordance with EU Directives. Additional legislative documents, supporting such system are European Standards which describe in detail particular issues connected to biosafety in laboratories, industry and environment. European standards are adopted to Polish standardization by Polish Committee for Standardization.
Rapeseed (Brassica napus L.) is the most important oilseed plant in Poland. Genetically modified (GM) rapeseed is planted on 18% of total rapeseed area in the world. The most frequent genetic modifications in rapeseed gave transgenic lines that are herbicide tolerant or have altered fatty acid composition. Coexistence of conventional and GM rapeseed is difficult due to several facts related to biology of this species. Contamination of rapeseed conventional varieties with rapeseed GM seems to be unavoidable during flowering time, harvest, storage and transport. For this reason monitoring of GM rapeseed in Poland is very important. At the moment no validated method is available for quantification of GM in rapeseed. Therefore development and validation of qualitative methods for rapeseed transgenic lines in routine food and feed analysis are necessary.
At present most classical pharmaceutical technologies reach high level of industrial perfection. The best example of those achievements is the biotechnology of penicillins. Biosynthetic penicillin production using highly productive strains of Penicillium chrysogenum is followed by an enzymatic hydrolysis of the product using microbial penicillin acylase, the best sources of which are recombinant strains of Escherichia coli. The resulting aminopenicillanic acid is the starting material for chemical synthesis of a large number of semisynthetic penicillins. Research and development of the biotechnology of antibiotics created solid fundamentals for other biotechnological processes in the pharmaceutical industry, i.e. production of amino acids, organic acids, enzymes and enzyme inhibitors, vitamins, alkaloids, dextran, steroid drugs and others. In addition to the continuous improvement of the classical technology completely new bioprocesses were introduced to the pharmaceutical industry in the recent years as a result of unprecedented progress in genetic engineering, hybridoma techniques and cell cultures in vitro. The new group of polypeptide/protein biopharmaceuticals includes peptide hormones (e.g. insulin, growth hormones, gonadotropins), growth factors (e.g. insulin-like growth factors, epidermal growth factors), haematopoietic growth factors (e.g. erythropoietin, colony stimulating factors), blood proteins (e.g. clotting factors VIII, IX, XII and XIII, tissue plasminogen activator, streptokinase), cytokines (e.g. interferons, interleukines and tumor necrosis factor) and monoclonal antibodies. Another new area of genetic engineering and biotechnology is the production of nucleic acid drugs, which are proposed for both gene and antisense therapy.
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