The Idea behind the process
Adenoviruses are commonly used as efficient genetic vaccine vectors capable of letting the cell express several antigens to obtain a stronger immune response in patients. Through a long process, the vector has been made intrinsically safe. Furthermore, the hurdle of a pre-existent neutralizing antibody arsenal capable of interfering with already known vectors has been overcome. In particular, these results were obtained through a selection of vectors never previously recognized by the human immune system, and capable of transporting a genetic message to the protein-making apparatus of human cells. The message instructs them on how to construct a portion of an antigen and how to show it to the immune system. This enables the vaccine to “teach” the immune system, improving its capability to activate a “search and destroy” function when in presence of the disease (i.e. pathogens like Influenza, Zika, Rift Valley fever, Ebola or different cancer type-associated cells).
The approach described above is mainly research focused. Advent has taken up the challenge to efficiently transfer research know-how and expertise in this field to a new level. Approximately 10 years ago, we started to explore how to produce this new generation of vaccines under cGMP conditions, ready to be delivered to the selected clinical sites.
In the process, every step has been analyzed to reach a robust, reproducible level of quality and safety, as requested by cGMP regulations.
To achieve this result, all the small-scale research process steps have not been simply scaled up, but rather completely re-designed, incorporating the use of state-of-the-art, cGMP-compliant instruments. The steps have then been translated into Standard Operating Procedures, tested and refined to improve the overall process yield. A particular effort has been made to ensure these procedures maintain the highest quality level, guaranteed by continuously trained production staff and by an extensive in-process and release test matrix.