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Rosane Cuber Guimaraes, Speaker at Vaccines Conferences
Bio-Manguinhos/ Fiocruz, Brazil
Title : Analytical transfer of COVID-19 recombinant vaccine between fiocruz and astrazeneca

Abstract:

Since the beginning of Sars-CoV-2 virus pandemic in Brazil on March 2020, Fiocruz has been part of various national and international fronts for the search and production of a vaccine against COVID-19. With a long history and a tradition of more than 70 years in vaccines production, Fiocruz signed an agreement with the biopharmaceutical AstraZeneca to produce in Brazil the vaccine against the new coronavirus, an immunizing agent developed by University of Oxford. A huge Project was stablished in Bio-Manguinhos/Fiocruz in order to execute all the steps needed to deliver the vaccine to Brazilian government. One of the work fronts was linked to Technology Transfer, considering DP & DS Production Transfer and DP & DS Analytical transfer.

This paper aims to demonstrate how the analytical transfer of COVID-19 Recombinant Vaccine between Fiocruz and AstraZeneca was essential for the complete transfer of COVID-19 vaccine production in Brazil.

A process flow modelling using Bizagi Modeler was performed to demonstrate the main steps of COVID-19 Vaccine Analytical Transfer, as well describe each step and documents generated. With this process design, it was possible to comprehend difficulty, lessons learned and accelerators of the transfer that allowed it to be made in a short time and successfully concluded. Comparing COVID-19 analytical tech transfer with other transfers already performed by the Institute, it was possible to verify the main differences between them and all the lessons learned to be used for the future projects.

Some of the enablers of this project: a) As Bio-Manguinhos is a worldwide product of viral vaccines, there was already prior knowledge in the methodologies and platforms used. b) the Institute already had a transversal management of innovation project activities and the portfolio of existing products, and c) a Quality Management System that already covered all the necessary documentation structure to speed up the transfer process.

As it was a project performed in a shortest time, some difficulties were faced by Quality Control team during all the projects. Most of the equipment and consumables came from outside the country, and all the logistic to receive them are very complex and bureaucratic. So, some items took a long time to arrive, affecting some deadlines previously agreed with the partner. Another difficult was related to the trainings: due to the pandemic and the impossibility of travels, there was an impossibility of face-to-face training. AstraZeneca sent videos of the methods, and then Bio-Manguinhos’ QC team performed the analytical transfer based on them. And a last difficult that can be emphasized, is the one related to the difficult to hire new employees with specialized knowledge in a short period of time. It was a race against time because everything needed to be ready in QC to test Drug Product and Drug Substance from Process Perfomance Qualification (PPQ) Lots.

The main goal of this project was the licensing of Drug product in 8 months and the licensing of nationalized Drug substance in 11 months. Now, Fiocruz can distribute nationalized vaccine to Brazilian Ministry of Healthy.

Biography:

Dr. Rosane Cuber studied biomedicine at Rio de Janeiro State University, Brazil and has specialization in molecular biology from the University of Brasilia and master in biochemistry at Federal University of Rio de Janeiro. She received her PhD degree in sanitary surveillance at the National Institute of Quality Control in health (INCQS/Fiocruz)). In Bio-Manguinhos since 2000, has experience in the area of collective health, with emphasis on public health, acting mainly in the following themes quality, development of viral vaccines, regulation and biosecurity. She is currently the Deputy Director of quality of Bio-Manguinhos/Fiocruz.

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