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Marcello Fidaleo: The power of DOE in process development

"In the field of biotechnology and agriculture, DOE is really a must," says Marcello Fidaleo is Asso...Design of experiments (DOE) is a powerful tool in development and manufacturing. In combination with Quality by Design (QbD), DOE methodology is specifically useful in the pharmaceutical and biomanufacturing industry.

Marcello Fidaleo – who is Associate Professor of Innovation at the University of Tuscia, Italy – presents an introduction to QbD and DOE with a real-world case study at the JMP Explorers seminar in Milan on June 13 (seats are still available; sign up here). If you are not based in Milan, you can still join us: We are streaming the event live online. Sign up for the online seminar.

Prior to the event, I asked Fidaleo a couple of questions:

### How did you become interested in statistics and specifically design of experiments as a career choice?

As a chemical engineering student, I was not exposed to statistics or design of experiments. That is unfortunate because DOE has had such an enormous impact on the chemical industry in process improvement. Later, when I was a PhD student at the University of Tuscia, my advisor prompted me to study DOE: In the field of biotechnology and agriculture, DOE is really a must. So, I audited a class at the University of Minnesota, and I got really engaged in the subject. From there, I started to apply DOE in my research, to develop classes on the subject and to collaborate with companies in the food and biotechnology field. The apex of this process was when I visited the Biomanufacturing Training and Education Center (BTEC) in Raleigh, North Carolina. We developed biomanufacturing case studies and experiments with JMP to set up a class, which has been very successful. DOE is really a powerful tool that can help speed process development and improvement in virtually any field.

### What do you hope attendees will take away from the seminar?

I hope that the attendees will get a good overview of what DOE is and how it can be applied to process development in biomanufacturing. The seminar will have a hands-on approach with numerous examples and case studies and a JMP demo dealing with the biomanufacturing field. I hope the seminar will help attendees who are interested in QbD to start applying DOE in their work.

We are looking forward to the event. Sign up for it here for the online streaming and here for the in-person seminar in Milan – it's free!.

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