Design of Experiments in Biopharmaceutical Development
Sponsored by: Batavia Biosciences
- Quality By Design
- Process Development
- Process Control
- Process Characterization
Date: 22 September
Time: 3PM London/10AM New York
Improved control on process robustness by implementing predictive modelling utilizing novel design of experiments data
Currently process development and characterization in biopharmaceutical development should be performed according to the concept of Quality by Design (QbD) as outlined in the FDA imperative. The focus of QbD is that the quality should be built into a product with emphasis on product understanding, process understanding and process control. For process understanding and process control the relation between the critical process parameters and the critical quality attributes needs to be established. DoE proves to be a useful method to obtain this link, significantly reducing the amount of time consuming experiments.
At Batavia Biosciences we use DoE in pharmaceutical development. For example, we use DoE to identify parameters that affect the virus inactivation rate and yield. Furthermore, DoE is used for the initial screening of multiple parameters to define the critical parameters that affect the critical quality attributes (CQA’s). We will translate these parameters in a statistical model to explain the different inactivation rates and we will step into defining the operational parameter ranges to obtain the required quality (design space) and the optimal settings within the design space for quality, process performance and robustness. Finally, we will show how DoE is used for verification of the process or robustness testing.
In this webinar you will learn how to use DoE in planning your experiments and analyzing the data obtained. We will guide you through all phases of a DoE workflow and show you how Batavia Biosciences uses it to optimize USP and DSP development. So if you are interested in accelerating your biopharmaceutical processes and optimizing your development, please register.
Senior Bioprocess Scientist at Batavia Biosciences
Since 2011 Danielle Horneman works as a Project Manager at Batavia Biosciences. Prior to that she built on her extensive experience as DSP scientist, specialized in process development, process modelling, process simulation, Design of Experiments, Quality by Design and (continuous) chromatography.
She holds a PhD in Bioseparation Technology and a Master in Chemical engineering and Bioprocess Technology from the Technical University of Delft at which she is a guest speaker for the Advanced Course Downstream Processing.
Danielle Horneman is a valued speaker in the field of bioprocess development, for example at the Wageningen University, Bioseparation Forum Chromatography and the World Vaccine Congress.
Key Learning Objectives
- How to accelerate your biopharmaceutical process
- How to optimize your biopharmaceutical development
- Biopharmaceutical Heads of R&D
- R&D Project Managers
- CSO in Biopharmaceutical Start-up Organizations
- CEO in Biopharmaceutical Start-up Organizations
- Academics Working in Biopharmaceutical Grants
- Consultants in Biopharmaceutical Process Development
- Investors in Biopharmaceutical Products Development