Designed Experiments for Biotech & Pharma
Achieve Breakthroughs in Your Biotech and Pharmaceutical Process Developments
Master the secrets of design of experiments (DOE) in this biotech and pharma-specialized workshop, greatly accelerating your research and development. Discover how DOE tools facilitate creation of efficient and reliable processes and superior products. Case studies from the industry illustrate every concept.
This workshop covers all the practical aspects of DOE needed to improve your product development, as well as optimize R&D and manufacturing processes. You will learn how to:
- Take advantage of multifactor testing
- Ensure success via a four-step DOE planning process
- Assess statistical validity using ANOVA and diagnostics
- Discover hidden interactions
- Capitalize on efficient fractional designs for screening or characterization
- Use tools for power and precision to 'right' size designs - not too small or too big
- Apply response surface methods (RSM) for process optimization
- Develop multicomponent mixture designs for optimal formulations
- Make the most from your predictive models
- Optimize multiple responses to find your sweet spot
Case Studies Provide Practice
Use Design-Expert® or Stat-Ease® 360 software to design and analyze experiments throughout the workshop. The software provides easy-to-use graphical tools to find key variables and view results.
This course will be run as five (5) half-day Zoom sessions - Monday - Friday (9:00am - 12:30pm US Central Time) in the stated week. Sessions will be recorded in case of a missed session.
Course contents subject to change.
Session 1
- Introduction to Factorial Design
- Power
Session 2
- Blocking
- Fractional Factorials
Session 3
- Intro to Response Surface Methods
- Response Surface Designs
- Multiple Response Optimization
Session 4
- Optimal Designs and Multilinear Constraints
- Intro to Mixture Design
- Simplex and Optimal Designs
Session 5
- Mixture and Process Combined Designs
- Mixture-Amount & Mixture-Categoric Designs
- Next Steps
It will be assumed that all students have completed the following prerequisites. This knowledge is essential for success in the course.
Knowledge of basic statistics (mean and standard deviation), and exposure to simple comparative experiments (e.g. two-sample t-test) are required. To refresh these skills and review basic concepts and terminology, please take the online PreDOE course prior to the workshop. It takes 2-3 hours to complete. You can work at your own pace. Access the PreDOE here.
Basic knowledge of Stat-Ease software is assumed. If you are not familiar with the software, then please download a trial of Stat-Ease 360 software (if you do not already have access to it) and work through the first tutorial: One Factor - Bowling, found in the Help system. This will show you how to navigate and introduce the basics.
PDHs: 15 (equals 1.5 CEUs)
This course will be held via Zoom Meetings. You will need to download the Zoom Cloud Meeting app prior to the first session.
Recommended Texts and Software
- DOE Simplified: Practical Tools for Effective Experimentation, 3rd Edition by Anderson & Whitcomb
- Stat-Ease® 360 or Design-Expert® software for experimental design