Process robustness is the key industrial need in bioprocesses. However variability in raw materials as well as due to biological nature call for tools to identify, monitor and control process variations along the process chain. The current contribution wants to motivate solutions of mechanistic model development, PAT solutions and data science solutions for enabling upstream manufacturing robustness of bioprocesses. The following elements will be covered for example:
• Workflows how goal driven mechanistic models can be developed
•Models as PAT tool: Demonstrations of cases in which models are solutions to measure less
•Multiparametric control and event prediction
We will show case studies in which tunable promoter systems along with model based control techniques were successfully deployed to enable robust upstream processing to enable robust downstream processing. This solution will pave the ways to continuous biomanufacturing.
Take Home Message:
Models can be set up by process developers. Model based tools are available to allow robust upstream processing for robust downstreaming. This full interpretation of PAT is the key enabler for continuous biomanufacturing.