The Challenge

Active Virosomes (AV), a proprietary vaccine delivery technology, have the potential to perform as an effective vaccine against chikungunya (and other diseases). In order to proceed to pre-clinical studies, manufacturing needs to be scaled up and maintaining quality control is of paramount importance.

Indirect animal studies are typically used to assess manufacturing quality and variations in size and loading. A direct method of assessing variations between AV batches was needed to improve efficiency and reduce the reliance on animal studies.

The Solution

The Activirosomes team worked with scientists at Diamond as part of the Bridging for Innovators programme. Using a combination of super high-resolution microscopy and soft X-ray tomography, the team characterised AV populations including vesicle size distribution and variations in antigen loading.

Manufactured batches were compared to assess the extent and nature of batch-to-batch variations. The interactions of AVs with cells were also investigated.

The Benefits

The experiments were sensitive to differences in antigen loading and vesicle size and a robust and direct analytical method was established to characterise AV populations which can be used to assess any manufacturing changes required for scale up. 

This method is both more efficient and sensitive than existing methods and reduces the reliance on animal studies. Preliminary results verify antigen expression on the surface of host cells.