WP3: Consistent bioprocess development & scale-up

Consistent bioprocess development & scale-up (6-48 months), Research & Training, Lead: TUB

Objectives: To develop experimental strategies for high throughput process screening and to investigate experimentally the effects of heterogeneity in upstream and downstream process units in response to the change in operating conditions during scale-up for a range of bioprocesses to ensure generic applicability across a range of processes from probiotics to recombinant proteins and monoclonal antibodies. Capture these effects in a modelling framework feeding into WP 4.

Description: Project 3.A (host DTU), Project 3.B and Project 3.C (host TUB), Project 3.D (host SAN), Project 3.E (host CHN)

Project 3.A: Task 3.1 – Optimal DoE for microbioreactors in model system; Task 3.2 – Optimal DoE for microbioreactors in industrial case study system (FUJI, SAN).

Project 3.B: Task 3.3 – Estimation of the population heterogeneity due to operating conditions in model system; Task 3.4 – Testing the methodology on an industrial case study system (SAN, CHN).

Project 3.C: Task 3.5 – Methodology to estimate the effect of oscillations in large-scale industrial reactors on the quality of recombinant proteins based on microreactor model system; Task 3.6 – Testing the methodology on industrial case study system (FUJI, SAN).

Project 3.D: Task 3.6 – Effect of feeding strategies on scale-up in model systems; Task 3.7 – Testing the methodology on industrial case study system (FUJI, SAN).

Project 3.E: Task 3.8 – Modelling methodology to scale-up freeze-drying unit performance; Task 3.9 – Testing the methodology on industrial case study system (CHN, FUJI).

Deliverables: D3.1 – Methodology to investigate population heterogeneity formulated (m.20); D3.2 - Methodology to investigate oscillation effects on product quality (m.20); D3.3 – Methodology to capture freeze-drying scale up effects formulated (m.20); D3.4 – Population heterogeneity methodology tested on model system (m.26); D3.5 – Oscillation effect/product quality methodology tested on model system (m.26); D3.6 – Feeding strategy on scale-up tested in model systems (m.30); D3.7 – Freeze-drying scale-up methodology tested on a number of organisms (m.30); D3.8 – DoE and optimal design tested on a model system (m.30); D3.9 - Population heterogeneity methodology validated on industrial case study (m.42); D3.10 - Oscillation effect/product quality methodology validated on industrial case study (m.42); D3.11 – Feeding strategy on scale-up validated on industrial case study (m.42); D3.12 - Freeze-drying scale-up methodology validated on industrial case study (m.42); D3.13 - DoE and optimal design validated on industrial case study (m.42)