Technical-economic analysis of a Peruvian RNA vaccine production plant against COVID-19

Abstract

Objective: To carry out a technical-economic analysis of a plant for the production of RNA vaccines against COVID-19 to cover the local Peruvian demand. Materials and methods: With the use of a specialized software in bioprocesses and local resource costs, it was possible to simulate a whole bioprocess: i) Primary manufacturing (RNA synthesis, purification using tangential filtration, size exclusion chromatography and lipid encapsulation (RNA-LNP), which allowed to produce up to 0.019Kg of RNA-LNP/batch; and ii) Secondary Manufacturing (dispensing and filling of vials). In this way, fixed investment costs (CaPex), operating costs per batch (OpEx) and packaging costs (CE) were calculated. Results: Based on the simulated model, to cover the total demand (32.6 million Peruvian citizens → 100 million doses → ~ 3Kg of synthetic RNA) will require 160 batches produced in a period of 10 months in a single facility. The total investment estimated for the plant is US$791.2 million: CaPex [US $ 91.5 million (68.8% correspond to validation actions and start-up activities)]; OpEx per lot [US $ 4.14 million (97.7% associated with input costs)] which would amount to US$ 662.7 million (160 lots) and one CE: US $ 37 million. The estimated cost per dose was calculated at US$ 7.91. Conclusions: The simulation of bioprocesses gives us an approximation of the technical-economic component to establish investment opportunities in a plant that produces RNA vaccines in Peru, serving as an input for other plants that produce biologics that meet the demands of national public health.