Abstract

SANTIAGO, Jose G; ZAMORA, Nelson C; QUINTANA, Noriega  and  OLMO, Gabriel. Microfiltration sistem dimension for using in Pertussis Vaccine toxin production in the Instituto Nacional de Higiene “Rafael Rangel”. INHRR [online]. 2012, vol.43, n.1, pp.020-024. ISSN 0798-0477.

Tangential Flow Filtration (TFF) technology was evaluated to process Whole Cell Pertussis Vaccine which is produced by Bordetella pertussis bacterium. Microfiltration (MF) is used to recovery cells to produ ce the vaccine. MF pro - cesses was evaluated to specify the filters and corresponding critical process parameters to scale-up the application. As part of the evaluation, flow rate, processing time, yield and product attributes were characterized. The cell harvest con taining the Whole Cell Pertussis was processed using a laboratory scale TFF system designed to pro duct the TFF effect. The evaluation demonstrated that a cassette in suspended screen format and membrane with 0.2μm pore is the right selection for the MF step. It showed 100% of cell recovery without cell transmission to the filtrate and average process flux of 54.00 L/m2h. These results were used to scale-up the application to process the industrial volume of 650 liters in 3 hours of processing time. Membrane area sizing of MF to be acquired is estimated in 20 m².

Keywords : Whole Cell Pertussis; Cell Separation; Microfiltration.