Introduction to Design of Experiments (DoE)
for Bioprocess Analysis and Optimization
|10% Discussion/group activity|
|50% Hands-on lab experience|
|80% Fundamentals and concepts|
|20% Industry applications|
Why should you attend?
To learn the fundamental principles of Design of Experiments (DoE) methods applied to analysis and optimization of bioprocesses. DoE is critical to defining the design space for a process, which is central to the quality by design concepts presented in the ICH Guideline for Development and Manufacture of Drug Substances Q11. This course focuses on the application of DoE methods through the use of JMP statistical software, bioprocess case studies, and hands-on laboratory activities. The case studies, which focus on microbial fermentation and provide real data, look at the effects of factors such as medium components, induction temperature and time on microbial growth and protein (product) production.
Attend and you will learn
- Basic statistical concepts required for DoE; these include hypothesis testing, confidence intervals, statistical models and Analysis of Variance (ANOVA)
- How to design and analyze experiments for the characterization and optimization of bioprocesses using factorial, fractional factorial, and response surface design concepts
- How to interpret the output of experimental design software—for example, normal probability, interaction, contour and residual analysis plots or ANOVA tables for factorial or surface response models
- How to use the popular JMP software in designing and analyzing experiments
Who should attend
The course is targeted to all those interested in bioprocess development and optimization, particularly those new to DoE techniques, including:
- Bioprocess development scientists and engineers
- Process validation staff interested in defining operating ranges and attribute specifications
- Other professionals with previous hands-on bioprocess experience who want to learn about DoE
Attend and you will receive
- 21.5 hours of instruction (2.1 Continuing Education Units)
- Notebook containing all course lecture and lab materials
- Morning break
- Afternoon break
- Certificate of attendance
Dr. Marcello Fidaleo is an assistant professor in the Department for Innovation in Biological, Agro-Food and Forest Systems at the University of Tuscia, Italy, where he teaches unit operations and design and analysis of experiments for the food industry. His research interests include membrane processes and enzymatic and microbial processes in the area of food biotechnology. He has carried out research as a visiting scholar at the Biotechnology Institute of the University of Minnesota and as a Fulbright scholar at the Department of Chemical and Biomolecular Engineering of North Carolina State University.
Dr. Fidaleo holds a master's degree in chemical engineering from the Sapienza University of Rome and a doctorate in food biotechnology from the University of Tuscia.
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A 20% discount is available to:
- Employees of BMF companies
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A 40% discount is available for NIIMBL members for the following courses:
- Hands-On cGMP Biomanufacturing of Vectors for Gene Therapy
- Hands-on Essentials of Automation for Biomanufacturing
Check out BTEC’s professional development certificate program for an additional way to save money on short course costs.
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