Evaluation and scale-up of single-use bioreactors for the production and harvesting of a hepatitis C vaccine candidate
June 12-17, 2016
The present work examines the suitability of single-use bioreactors for production of a Hepatitis C Virus-Like Particle (VLP) vaccine candidate using the baculovirus expression system with Sf9 cells. It can be shown that a Mobius® 3L bioreactor results in viable cell concentration, viability, growth kinetics, stability and VLP production that are comparable to standard glass bioreactors. A simple translation of hydrodynamic working parameters between the two systems is adequate to match performance. Furthermore, we report on the successful scale-up of this disposable alternative from a 3L to a 50L scale using minimal optimization. These results demonstrate the potential and ease of use of this technology for the production of complex biopharmaceutical products. Using the 50 liters harvested from the run, we evaluated depth filtration and compared the results to centrifugation. Multiple filter trains with different properties were tested and the results on recovery, turbidity and impurity reduction will be presented and discussed.
Alex Xenopoulos, Lénaïg Savary, Ricardo Silva, João Clemente, Rute Castro, Sofia B. Carvalho, Mafalda Moleirinho, Paula Alves, Manuel Carrondo, and Cristina Peixoto, "Evaluation and scale-up of single-use bioreactors for the production and harvesting of a hepatitis C vaccine candidate" 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/47