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


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Abstract

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.

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About the authors

Victor P. Trukhin

Saint Petersburg Research Institute of Vaccines and Sera and Enterprise for the Production of Bacterial Preparations, Federal Biomedical Agency; Saint Petersburg State Chemical-Pharmaceutical University

Email: truhin64@gmail.com
Director of the Saint-Petersburg scientific research institute of vaccines and serums and the enterprise for the production of bacterial preparations, Professor of the Department of Immunobiotechnology, SaintPetersburg State Chemical and Pharmaceutical University (SPbSChPhU) Saint Petersburg, Russian Federation

Igor A. Narkevich

Saint Petersburg State Chemical-Pharmaceutical University

Email: igor.narkevich@pharminnotech.com
Rector, Head of the Department of Management and Economy of Pharmacy , Doctor of Pharmaceutical Sciences, Professor Saint Petersburg, Russian Federation

Elena P. Nacharova

Saint Petersburg State Chemical-Pharmaceutical University; Latin American Institute for Biotechnology Mechnikov

Email: e.nacharova@mecnikov.org
Medical Director of Latin-American Institute for biotechnology Mechnikov, Associate Professor of the Department of Immunobiotechnology SPbSChPhU, PhD Medicine Saint Petersburg, Russian Federation

Stanislav V. Uiba

Latin American Institute for Biotechnology Mechnikov

Email: s.uiba@mechnikov.org
Director General Saint Petersburg, Russian Federation

Irina I. Basakina

Saint Petersburg State Chemical-Pharmaceutical University

Email: irina.basakina@pharminnotech.com
Associate Professor of the Department of Management and Economy of Pharmacy Saint Petersburg, Russian Federation

References

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