Bibliographic citations
Yañez, S., (2023). Diseño del proceso downstream para la producción de vacunas de partículas virales para la COVID-19 recuperadas de nicotiana benthamiana en Perú [Tesis, Universidad de Ingeniería y Tecnología]. https://hdl.handle.net/20.500.12815/326
Yañez, S., Diseño del proceso downstream para la producción de vacunas de partículas virales para la COVID-19 recuperadas de nicotiana benthamiana en Perú [Tesis]. PE: Universidad de Ingeniería y Tecnología; 2023. https://hdl.handle.net/20.500.12815/326
@misc{renati/230622,
title = "Diseño del proceso downstream para la producción de vacunas de partículas virales para la COVID-19 recuperadas de nicotiana benthamiana en Perú",
author = "Yañez Encalada, Sofía Alejandra",
publisher = "Universidad de Ingeniería y Tecnología",
year = "2023"
}
The design of a downstream process for the production of virus-like particle vaccines for COVID-19 recovered from Nicotiana benthamiana in Peru was carried out using agrobacterium tumefaciens method as an advantageous expression system of the viral antigen gene. The plant was selected to act as a bioreactor in order to produce viral particles under certain conditions defined from a literature review (temperature, growing period and agroinfiltration method). The downstream process consists of four main stages: extraction (primary disc centrifuge and high-pressure homogenizer), clarification (secondary disc centrifuge and depth filter), purification (affinity and anion exchange chromatography) and concentration and formulation (ultrafilter, sterile filter and formulation equipment). A production capacity of 600 kg biomass/batch was defined and the operational parameters for the proposed equipment were also established. The mass and energy balances were carried out to select each equipment regarding the design heuristics and operating conditions of the process stages. The affinity chromatography stage was depicted mathematically using adsorption models to describe the process kinetic by the Langmuir isotherm. Matlab simulation software was used to solve the differential equations that represent the process model and the initial flow rates were modified. The best results were obtained when operating continuously in a three-column period counter-current chromatographic array at 200 cm/h which allows to obtain a productivity of 8.58 g/L/ h. The purity requirements according to the specifications of the Good Manufacturing Practices in biopharmaceutical industries and the biological risks associated to the process were evaluated obtaining 371 g of purified and formulated product, which provides approximately 89.9 million doses per batch. Based on each activity in the process, 8 batches are obtained per year, the viability was determined in terms of NPV (207 363 636.35 US$) and IRR (76%), concluding that it is viable and profitable.
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