Cambridge Healthtech Institute Training Seminars offer real-life case studies, problems encountered and solutions applied, and extensive coverage of the basic science underlying each topic. Experienced Training Seminar instructors offer a mix of formal lectures, interactive discussions and activities to help attendees maximize their learning experiences. These immersive trainings will be of value to scientists from industry and academic research groups who are entering new fields – and to those working in supporting roles that will benefit from an in-depth briefing on a specific aspect of the industry.

TS6A: Design of Experiments for Bioprocess Analysis

Instructor:

Marcello Fidaleo, PhD, Teaching Fellow at the Biomanufacturing Training and Education Center of North Carolina State University (Raleigh, NC, USA); and Associate Professor at University of Tuscia (Viterbo, Italy).

Seminar description:

The aim of this training seminar is to provide the attendees with an introduction to the Design of Experiments (DoE) methods applied to analysis and optimization of bioprocesses. It focuses on the application of DoE methods using lectures, JMP statistical software (SAS Institute, NC) and case studies. The case studies, which provide real data, focus on microbial fermentation, chromatography and pharmaceutical product formulation. Attendees will receive a practical overview of the following topics: basic statistical concepts for DoE; how to use factorial, fractional factorial, and response surface designs for the characterization and optimization of bioprocesses; how to interpret the output of experimental design software (normal probability, interaction and contour plots or estimated coefficients tables for factorial or surface response models). Attendees are invited to bring their own laptops to get hands-on experience with JMP (it is suggested to pre-install a free 30-day trial downloadable on-line at www.jmp.com), pen and notepaper.

Topics include:

• Introduction to DoE and examples of applications to bioprocess analysis and optimization.
• Basic concepts for DoE: mean and experimental error, statistical models, confidence intervals, hypothesis testing.
• Factorial designs: main effects and interactions and relating plots, regression approach, contour and surface plots, cube plot, residuals plot.
• Unreplicated factorial designs.
• Fractional factorial designs.
• Response surface designs.
• Multiple responses.
• Application of DoE methods in design space building for Quality by Design (QbD).
• Case studies on microbial fermentations, chromatography and pharmaceutical product formulation.
• Use of JMP software for DoE and data visualization.

Target audience:

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, along with other professionals who want to learn about DoE.

What participants will gain from attending the seminar:

By attending this seminar, students will learn basic statistical concepts required for DoE (including hypothesis testing, confidence intervals, statistical models and Analysis of Variance); how to design and analyze experiments for the characterization and optimization of bioprocesses; how to interpret the output of experimental design software; how to use the popular JMP software in designing and analyzing experiments.

Instructor biography:

Marcello Fidaleo is an associate professor at the University of Tuscia (Italy), where he teaches unit operations and design and analysis of experiments for the food and biotechnology industry. He is also a teaching fellow at the Biomanufacturing Training and Education Center of North Carolina State University (Raleigh, USA) where he teaches a class on DoE for Bioprocess Characterization and Optimization. Marcello has about fifteen years of experience in design of experiments and data modeling in the field of membrane separation, enzymatic, microbial and chemical processes. He is the author of more than 40 scientific papers published on peer reviewed journals and has been a scientific consultant for companies operating in the fields of chemistry, biotechnology and food. Marcello 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.

Training Seminar Information

Each CHI Training Seminar offers 1.5 days of instruction with start and stop times for each day shown above and on the Event-at-a-Glance published in the onsite Program & Event Guide. Training Seminars will include morning and afternoon refreshment breaks, as applicable, and lunch will be provided to all registered attendees on the full day of the class.

Each person registered specifically for the Training Seminar will be provided with a hard copy handbook for the seminar in which they are registered. A limited number of additional handbooks will be available for other delegates who wish to attend the seminar, but after these have been distributed, no additional books will be available.

Though CHI encourages track hopping between conference programs, we ask that Training Seminars not be disturbed once they have begun. In the interest of maintaining the highest quality learning environment for Training Seminar attendees, and because seminars are conducted differently than conference programming, we ask that attendees commit to attending the entire program, and not engage in track hopping, as to not disturb the hands-on style instruction being offered to the other participants.