Newcastle University

Modelling tools in bioprocess development (6-48 months), Research & Training, Lead: DTU

Objectives: To integrate the modelling methods for using early process development experimental data and models generated in WP1 together with new models developed in WP2 into a versatile modelling toolbox that enables effective rapid bioprocess development.

Description: Project 2.A (host FUJI), Project 2.B (host UNEW) and Project 2.C (host DTU)

Project 2.A: Task 2.1 – Development of robust modelling methods for small scale upstream process modelling; Task 2.2 – Modelling methods for industrial process development through scale-up.

Project 2.B: Task 2.3 – Predictive modelling of processing routes based on product properties; Task 2.4 – Predictive modelling of product quality response to processing conditions.

Project 2.C: Task 2.5 –Mechanistic modelling risk assessment for recombinant yeast process; Task 2.6 – Mechanistic modelling based risk assessment for industrial case studies (CHN, FUJI, SAN)

Deliverables: D2.1 - Effective data streaming and augmentation methodology (m.18); D2.2 - Report on the most appropriate modelling methods for processing route prediction (m.18); D2.3 - Framework for PAT system design under uncertainty (m.20); D2.4 - Predictive models for the behaviour of two bioactive molecules in response to processing conditions (m.26); D2.5 - General framework for data representation with small batch numbers, across process scales (m.30); D2.6 - PAT system design under uncertainty: practical validation on a lab-scale recombinant yeast fermentation (m.30); D2.7 - PAT system design under uncertainty: validation on industrial case studies (m.40); D2.8 - Rapid bioprocess development strategy for diverse biomolecule structures (m.42).