Expediting Viral-Based Vaccines Development and Increasing Productivity
Part 1 Upstream Processing
We are all witness to the impact of the COVID-19 pandemic across the world, as it is bringing economies and life in general to a halt. In response to this pandemic, there are more than 90 vaccine candidates today that are in pre-clinical phase, with a few companies entering clinical trial phase I. We know that speed is of essence and that scale-up to large-scale production needs to be achieved by strategically balancing risks and speed.
This presentation first describes how vaccine developers can accelerate their timelines and develop highly efficient vaccine processes by using high throughput fully automatic multi-parallel bioreactor testing tools such as Ambr®, DoE software, and single-use solutions able to operate with mammalian cells, insect cells, and avian cells.
Key Learning Objectives
- Upstream process intensification methods, scale up tools and real case data will be presented for both suspension and adherent cell culture in fed batch, concentrated fed batch or perfusion mode.
- In particular, we will show how intensifying the working cell bank and the seed train bioreactor with perfusion helps saving half of the consumable costs and reduces the main bioreactor cell expansion time by up to 40%.
- Moreover, being able to achieve higher titers will be extremely important to keep scale up at a manageable level, which is critical during a pandemic situation.
- The author will finally show how coupling the production bioreactor with ATF, PAT tools and online multivariate process monitoring software can provide 10 to 50 times higher cell density and a the full automation and predictive control of the cell culture process performance.
Piergiuseppe Nestola, PhD
Manager of Process Technology Consultants
Piergiuseppe Nestola is Manager of Process Technology Consultants at Sartorius, where he is responsible for providing scientific, technological, and process leadership in the field of viral-based therapeutics. He holds a PhD in chemical and biochemical engineering from Universidade Nova de Lisboa (PT), where he developed virus purification processes for vaccines and gene therapies.
