Uncertainty analysis and risk assessment of the creation of a joint Russian-Nicaraguan biotechnology enterprise

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DOI: https://doi.org/10.29296/25419218-2020-04-04
Issue: 
4
Year: 
2020

V.P. Trukhin(1, 2), I.A. Narkevich(2), E.P. Nacharova(2, 3), S.V. Uiba(3), I.I. Basakina(2) 1-Saint Petersburg Research Institute of Vaccines and Sera and Enterprise for the Production of Bacterial Preparations, Federal Biomedical Agency, 52, Svoboda St., Krasnoe Village, Saint Petersburg 198320, Russian Federation; 2-Saint Petersburg State Chemical-Pharmaceutical University, 14, Lit. A, Professor Popov St., Saint Petersburg 197376, Russian Federation; 3-Latin American Institute for Biotechnology Mechnikov, Piso 7, Pasib de las Nassiones Unidas, El Centro, Centro 2, Managua, Republic of Nicaragua

The authors have analyzed the current programs and projects of the World Health Organization and found that special attention is paid to immunization, vaccines, and biotechnological preparations. To date, global manufacturers of immunobiological preparations face a number of problems in continuing to design, manufacture, and supply innovative and high-quality vaccines that meet the needs of countries, as well as in creating new production capacities in the countries and regions where this potential was previously absent. Today, the Russian Federation has been established to be an active participant in the assistance and development of the resources of a number of countries in the field of immunobiotechnology. The project to create a joint Russian-Nicaraguan biotechnology enterprise will be able to introduce Russian immunobiological preparations and technologies for their production on the markets of Central and Latin America. The authors provide a rationale for selecting key parameters to assess project risks. A risk situations classification has been developed; approaches and measures to minimize risks have been substantiated.
Keywords: 
biotechnology enterprise
vaccine
risk analysis
References: 
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