Challenges in the construction of a multi-product vaccine facility
June 12-17, 2016
A new multi-product vaccines facility in Sanofi Pasteur was designed and equipped with new state-of-the-art technologies. The construction of this building aims to increase capacity of producing pediatric vaccines and allowed to implement manufacturing process improvements, increase quality compliance level and addressed environmental, and safety concern. This new facility harbors three antigens processes from fermentation to purification and detoxification.
The project has been challenging on different points: new equipment, process transfer issues, new qualification/validation strategy and regulatory registration. Apart from global feedbacks on costs, organization, resources, performance and authorities communication strategies, focus was also directed towards the resolution of a process issue during validation steps. A trouble- shooting group has been mobilized to work on the different axes with a specific method.
Resolution of all the issues permitted the building registration, and therefore the vaccination of millions of children.
Rachel Appetiti, Fabien Barbirato, Gaëlle Bernard, Vincent Dalbies, Catherine Jourdat, Nadège Leray, Grégory Piquet, Christelle Plantard, and Nadège Poisson, "Challenges in the construction of a multi-product vaccine facility" in "Vaccine Technology VI", Laura Palomares, UNAM, Mexico Manon Cox, Protein Sciences Corporation, USA Tarit Mukhopadhyay, University College London, UK Nathalie Garçon, BIOASTER Technology Research Institute, FR Eds, ECI Symposium Series, (2016). http://dc.engconfintl.org/vaccine_vi/104