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Author:
Mansilla Hidalgo, Víctor
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Abstract
Given the great advances in the development of mRNA therapies against infectious diseases and the current pandemic situation, safe, efficient and productive mRNA production platforms are required. That is why this Final Degree Project aims to develop a platform for the production of mRNA vaccines against infectious diseases, such as SARS-CoV-2 or HIV, complying with GMP regulations. The configuration of this platform aims to develop an mRNA production protocol, for research and clinical use, from a pDNA and in vitro transcription, the fine-tuning of the documentation to comply with GMP and the performance of a risk assessment followed by a corrective action report.
In order to develop this platform, a bibliographic search has been carried out to select and compare methods and patents, and to be able to develop a mRNA production protocol in stages. A preparation of the necessary documentation has been carried out following the Creatio quality management system and an extensive risk analysis using the AMFE method followed by a CAPA plan with corrective measures.
In the results, it can be seen how, first, the theoretical design of the desired plasmid with the fluorescent GFP gene, named pBluescript-GFP II SK (+), has been obtained. The mRNA production protocol has been obtained based on a linearization of this plasmid, an in vitro transcription and a purification, thus obtaining a naked mRNA ready to administer or formulate. The following results are based on obtaining a risk analysis using the AMFE method, where a multitude of variables have been considered and risks have been detected that have subsequently been reduced or eliminated with the CAPA plan. Finally, all the documentation in GMP of specifications, production and quality control has been completed.
Due to the versatility and flexible manufacturing of mRNA, the work carried out, both documentary and protocol, can be optimized for future possible projects in Creatio.
Keywords: mRNA, mRNA vaccine, GMP, vaccine platform, infectious diseases.
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