Patents are of critical value for future commercial development of innovation. Knowledge of legal system dedicated for intellectual property rights is limited. Basic information concerning biotechnological invention and patenting are presented with focus on 'red' biotechnology.
Genetically modified organisms are the key step for innovative medicines. The innovative drugs in the 21st century will be in the majority of proteins, nucleic acids and their combinations. The critical issues in case of biopharmaceuticals are quality and reproducibility of production. These aspects are evident in biosimilars (generics) and protection of intellectual property rights.
Pharmaceutical biotechnology is 60 years old. Its development one can divide into three essential periods. Two of them have proceeded in past century. The first period started during the Second Warld War with the industrial production of penicillin and was microbiology-based (microbial metabolites as drugs). The second one was genetic engineering-based and started in 1982, when human insulin synthesized in recombinant bacteria was introduced by pharmaceutical industry to health care. The third period began in 2001 with the first descriptions of the human genome, and is genome-based (also proteome-based). Molecular biology with its new areas genomics, farmacogenomics and proteomics, together with bioinformatics and other sophfisticated tools developed at the end of XX century and introduced (the pharmaceutical and medical biotechnology of the XXI century) very new ideas and new approaches to drug discovery and designin. Pharmaceutical biotechnology (as well as pharmaceutical industry as a whole and world biotechnology as a whole) is entering upon the third phase of its development, a very integrated and globalized one.
Several reports and surveys of the perception of red biotechnology uses conducted in recent years show the complexity of European's attitude to innovative therapies which might be used in medicine. Polish people, as well as the rest of European nations in general, support the development of gene therapy or pharmacogenetics, whereas the issues of stem cells research and uses of genetic information are still under discussion. The results of various questionnaires prove that a rise of the optimism level in this matter is necessary. It occurred that in order to build public acceptability and confidence in biotechnology policy, it is crucial to ensure the society that moral and ethical aspects are taken into consideration.
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.
Current status of innovative drug industry is briefly presented with emphasis on new biopharmaceuticals introduced in the years 1995-2007. Adverse effects and problems of safety and effectiveness of these pharmacotherapeutics are reviewed. A separate part of the manuscript is devoted to the newly introduced methods of molecular diagnostics based on pharmacogenomics and employed in personalized medicine. Theranostic approach consisting in a joint use of drugs and companion diagnostics are characterized.
JavaScript is turned off in your web browser. Turn it on to take full advantage of this site, then refresh the page.