Automated Solution to Develop and Optimise Upstream Processe

Descriptions

VMIC requires the ability to rapidly develop and optimise upstream processes using a state-of-the-art Quality by Design (QBD) approach to ensure robustness as well as rapid development. The ability to execute a Design of Experiments (DoE) approach is integral to the assurance of robustness and furthermore ensures that the processes developed are well away from the edge of failure. VMIC will be a centre of excellence for vaccine development in the UK, and must also have the capability to respond rapidly to pandemic situations, therefore it requires a solution that will allow rapid development of robust processes for clients whilst also allowing a significant reduction in operator-hours and time to create credible processes for anti-pandemic vaccine candidates. The Sartorius Ambr250 HT system, including installation and 1 year comprehensive service, allows the simultaneous operation of multiple bioreactor vessels working under different operating parameters, with each parameter, addition, feed etc. controlled by robotics in response to a pre-defined operational plan. The time saved using such an automated system is significant and allows for the rapid development of processes in a fraction of the time required using a more traditional approach. It also allows for the scale-down validation of existing processing parameters, thus speeding up the robustness testing and subsequent validation of existing process parameters. The Ambr 250 HT system is unique in the market place due to the high level of automation and robotics employed to rapidly reduce the time spent in development of mammalian or microbial process, and the high level of automation, microbiological containment, robotics and integrated liquid handling, sampling, and on board sample storage. VMIC will be a centre of excellence for vaccine development in the UK, and must have the capability to respond rapidly to pandemic situations. The Ambr system will be integral to both these missions because the solution will allow rapid development of robust processes for clients whilst also allowing a significant reduction in operator-hours and time to create credible processes for anti-pandemic vaccine candidates.