Etvax - a one world vaccine to fight diarrhoea

Purpose and goal

The projects goal is to develop a formulation of the adjuvant dmLT in combination with our oral ETEC vaccine that will facilitate a simple, stable and commercially acceptable presentation of the vaccine together with the adjuvant. In order to succeed we have developed the whole process starting from fermentation, purification, formulation and development of analytical methods to be able to produce under GMP and release a GMP batch.

Results and expected effects

We have been successful in all steps of this project. The optimization of the fermentation has led to a more stable and predictable expression of dmLT. The optimization of the purification has been done both to adapt to a production in commercial scale and also to yield a much purer product. The formulation has been optimized in two steps, resulting in that dmLT is now stable in its presentation.

Approach and implementation

The approach and implementation has worked well. A time-limiting factor has been the shortage of slot-times for production at the Contract manufacturers and the very long lead-times for release. This has influenced the time-axis of the project. The implementation has otherwise exceeded expectations much depending on the thorough development work that has been done before the process has been transferred to the industrial partner.