E1: PILOT SCALE PRODUCTION OF AFCo1 AS VACCINE ADJUVANT.

The use of new adjuvants in vaccine formulations is a subject of current research. Only few parenteral adjuvants have been licensed. We develop a mucosal and parenteral adjuvant entitled AFCol (Adjuvant Finlay Cochleate 1) using dialysis procedures at lab scale. In order to increase the production process, we used a crossflow system (CFS) that allows easy scale up to obtain large batches in an aseptic environment. The aim of this work is to produce AFCol at pilot scale conserving adjuvanticity. As results the AFCol was successful produced by tangential filtration to scale pilot. It passes preclinical toxicity studies and preliminary stability. The nasal immunogenicity evaluated in Balb/c mice induced specific saliva IgA and serum IgG. The induction of Th-1 response was demonstrated by the induction of IgG2a, IFNγ, and not IL-5. The self adjuvant action as well as against co-administered antigens were similar to Lab scale lots. The AFCol obtained at pilot scale conserve the mean physicchemical and immunological characteristics for 2 years with no preclinical toxicity. [ABSTRACT FROM AUTHOR]