30 de mayo de 2023 a 1 de junio de 2023 Ciencias Naturales, Exactas y Ténicas
America/Havana zona horaria

New method of analysis based on Vulnerability and Risk applied in the Biotechnology Sector

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20m

Ponente

Juan Pablo Pomuceno Orduñez (Unidad Especializada de Biología Criminalística, Unidad Laboratorio Central de Criminalistica)

Descripción

New method of analysis based on Vulnerability and Risk applied in the Biotechnology Sector

Juan Pablo Pomuceno Orduñez1*, José Arquímides Castro del Pino2, Liset Friol García1, Rolando Carmona Fernández1.
1 Unidad Laboratorio Central de Criminalística, Cuba
2 Centro de Inmunología Molecular, Cuba
Correspondence: * jppomuceno@gmail.com

Abstract
The criminal investigation of the causes of failures that occurred during a biotechnological production constitutes a challenge due to the difficulty of discerning between: a failure due to an inherent risk [1-3] or an intentional action. Therefore, in this work an analysis method based on Vulnerability and Risk was proposed, which can facilitate the criminal investigation of the root causes of an unwanted event in the biotechnology sector. The Vulnerability assessment was carried out based on an equation that relates the indicators: exposure, susceptibility, resilience and supervision of the elements of interest; while the Risk was quantified through the Risk Priority Number [4]. The combination of both variables placed each root cause with its corresponding element of interest, in quadrants with different degrees of interest from a criminalistic point of view. A biotechnological production center in Cuba, affected by repeated microbiological contamination, was used as a case study. The proposed method allowed establishing an order of priority in the investigation of the root causes of the unwanted event and explained why the same root cause can be the consequence of a random failure or a malicious action. This type of root cause must be carefully investigated from a criminalistic standpoint. The proposed equation for Vulnerability estimation justifies what structural and non-structural changes can be implemented in a biotechnological production area to mitigate the Vulnerability of the elements of interest.

References
1. Kis, Zoltán, Shattock, Robin, Shah, Nilay & Kontoravdi, Cleo, Emerging technologies for low‐cost, rapid vaccine manufacture. Biotechnology journal, 2019. 14(1).
2. Cai, Ying, Rodriguez, Stephen & Hebel, Henry, DNA vaccine manufacture: scale and quality. Expert review of vaccines, 2009. 8(9): p. 1277-1291.
3. Uphoff, Cord C & Drexler, Hans G, Comparative PCR analysis for detection of mycoplasma infections in continuous cell lines. In Vitro Cellular & Developmental Biology-Animal, 2002. 38(2): p. 79-85.
4. Jahangoshai Rezaee, Mustafa, Yousefi, Samuel, Eshkevari, Milad, Valipour, Mahsa & Saberi, Morteza, Risk analysis of health, safety and environment in chemical industry integrating linguistic FMEA, fuzzy inference system and fuzzy DEA. Stochastic environmental research and risk assessment, 2020. 34(1): p. 201-218.

Autor primario

Juan Pablo Pomuceno Orduñez (Unidad Especializada de Biología Criminalística, Unidad Laboratorio Central de Criminalistica)

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