This multi speaker symposium will focus on the latest developments and application of microbial based production (yeast and E. coli).
Some of the topics to be addressed through case study examples include:
- New Technologies for Primary Recovery and Cell Harvesting
- Downstream Processing in Microbial Production
- Automation, Robotics and High Throughput Process Development
- Developing a Roadmap to Perform Effective Scale Up in Microbial Manufacturing
- Developing and Validating Process Monitoring and Control Technologies for Robust Monitoring of Microbial Production
- Upstream Processing - Optimising Yield, Expression and Strain Development
- Adapting New Technologies and Equipment for Large Scale Microbial Production
Overcoming Scale-Up Challenges through Effective Bioreactor Characterisation and the Use of Innovative Scale Down Model (SDM) Approaches
During the scale-up of a microbial fermentation process to 15kl, differences in performance and product quality were encountered. Combined empirical and modelling approaches to bioreactor characterisation were employed, along with the development of an innovative SDM to better understand and characterise the full scale process.
Richard Davies, Associate Director, UCB, UK
Evaluating the Robustness of Industrial Scale Bioprocesses: Bringing Scale Sown Reactors to High Throughput
Typically, bioprocesses on an industrial scale are characterized by inhomogeneities and consequently the microorganisms circulating in the reactor are exposed to perturbations in various parameters. The aim of scale-down approaches is to estimate the influence of these perturbations on cell physiology and the process.
Scale down experiments must therefore be planned based on the conditions in the large scale. For this purpose, technologies have been developed in the past years which allow typical parameters in the process to be measured dynamically in different zones of the industrial reactor and eventually the corresponding fluid dynamic models to be verified. From the analysis of the residence time probabilities in the different zones, e.g. by Euler-Lagrange CFD studies, scale-down regimes can be derived. In various studies we have shown that the phenomena observed on an industrial scale can be represented in three-compartment reactors. In this context a better understanding of the dynamic development of population heterogeneities are currently of special interest. With the aim of establishing relevant mathematical cell models that simulate the physiological properties of cells under perturbing conditions, we are currently developing parallel high-throughput strategies that allow even complex models to be parameterized in a few experiments.
Sebastian Hans, Head of High Throughput Bioprocess Development, Technische Universität Berlin (TU Berlin), Germany
Adapting New Technologies and Implementation of Single Use Systems
- Evaluating and overcoming problems of implementing single use systems in legacy microbial processes.
- Industry case study on implementation of single-use technologies including process development and characterisation, regulatory requirement, Extractables and Leachables assessment, etc.
- Scale-up approaches and process validation for disposable implementation.
Ying Gao, Product Development Specialist, Porton Biopharma Ltd, UK
The Time has come to Bring QbD to Inclusion Body Processing
Inclusion body processing is still based on empiricism rather than on sound process knowledge. State-of-the-art refolding processes mostly happen in unmonitored dilution approaches giving a lot of misfolded product and low space-time-yields. In will present how we tackle this challenge by introducing more monitoring and control in these processes.
Assoc. Prof. Oliver Spadiut, Group Leader Integrated Bioprocess Development, ICEBE, TU Wien