Over the last five years, we tailored our electrospray technology to help further the clinical development of Viaskin® and its subsequent commercialization.
During pre-clinical testing, we used two different prototypes. In 2009, we developed a third-generation machine capable of manufacturing patches for clinical trials.
For the Phase I and II of Viaskin® Peanut and Viaskin® Milk clinical trials, the industrial machine, called GEN3.1, was able to produce 15,000 patches per batch, which was sufficient for clinical needs. Overall, on a yearly basis, GEN3.1’s throughput is approximately 750,000 patches.
A new version of this tool, called GEN3.2, has been completed in the second half of 2014. This new generation manufacturing tool allows to produce larger batch sizes of around 60,000 patches, which are compatible with later-stage clinical development needs. Overall, on a yearly basis, GEN3.2’s throughput is expected to be approximately 2,250,000 patches.
We believe that a commercial-scale version of this manufacturing tool called GEN4.0, will be completed in 2016. DBV Technologies anticipates this tool will allow to produce commercial batch sizes, of around 500,000 patches, compatible with initial expected market demand. Overall, on a yearly basis, GEN4.0’s throughput is expected to reach approximately 20 to 30 million patches.