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08:30 - 08:40 10 mins
Monitoring and Control Strategy for Batch and Continuous Bioprocesses
Chairperson's Opening Remarks
  • Margit Holzer - Scientific Director, Ulysse Consult
08:30 - 08:40 10 mins
Microbial Manufacturing
Chairperson's Opening Remarks
08:40 - 12:30 230 mins
Info
Monitoring and Control Strategy for Batch and Continuous Bioprocesses
Monitoring and Control Strategy for Batch and Continuous Bioprocesses
  • Margit Holzer - Scientific Director, Ulysse Consult

- Definitions 

- Regulatory background 

- Overview of Bioprocess Controls for USP and DSP – What & Why & When to measure & control 

- Important requirements on process monitoring & control loops – from sampling, measuring, visualization, software, equipment and feed-back or feed-forward controls 

- Measuring points, frequency, data treatment and storage 

- Control hierarchies 

- Routine operation, cleaning, calibration, maintenance 

- Main differences between batch and continuous bioprocess control 

- Case studies 

  • Perfusion monitoring & control strategy  
  • Mab DSP monitoring & control strategy 

  

08:40 - 12:30 230 mins
Info
Microbial Manufacturing
Microbial Manufacturing
  • Richard Davies - Associate Director, UCB Celltech
  • Sebastian Hans - Head of High Throughput Bioprocess Development, Berlin University of Technology (TU Berlin)
  • Oliver Spadiut - Assoc. Prof.; Integrated Bioprocess Development, TU Wien
  • Ying Gao - Technical Support Specialist, Porton Biopharma Ltd


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

12:30 - 13:30 60 mins
Monitoring and Control Strategy for Batch and Continuous Bioprocesses
Lunch and Networking
12:30 - 13:30 60 mins
Microbial Manufacturing
Lunch and Networking
13:30 - 18:00 270 mins
Info
Monitoring and Control Strategy for Batch and Continuous Bioprocesses
Site Visit to Siemens, Living Lab Process Industries In Vienna

 

*Limited to 20 people. Places will be offered on a first come bases

13:30 - 18:00 270 mins
Info
Microbial Manufacturing
Site Visit to Boehringer Ingelheim, Regional Center, Vienna


*Limited to 20 people. Places will be offered on a first come bases

18:00 - 18:05 5 mins
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18:00 - 18:05
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