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Design of Experiments for Biomanufacturing

This workshop aims to introduce participants to the principles and applications of Design of Experiments (DoE) in the analysis of bioprocesses. Through a combination of lectures, hands-on use of JMP statistical software (SAS Institute), and real bioprocess case studies, attendees will learn how to apply DoE techniques in practice. The case studies, centered on microbial fermentation using real experimental data, explore how variables such as medium composition, induction temperature and duration affect protein (product) yield.

DatesCourseCostRegistration
May 12-13, 2026Artificial Intelligence in FDA-Regulated Manufacturing: From Foundations to Implementation$1,500Register
May 20–21, 2026Hands-On Essentials of Automation for Biomanufacturing$2,050Register
May 27–29, 2026Preparative Chromatography Column Packing: Lab to Process Scale$2,500Register
June 3–4, 2026Applied Cleaning Validation Practices: A STERIS Master Class$2,000Register
June 9–10, 2026Introduction to Biopharmaceutical Lyophilization$1,975Register
June 11, 2026Essentials of Spray Drying and Powder Analysis$995Register
June 16–18, 2026Fundamentals of Mammalian Cell Line Development$3,100Register
June 23–25, 2026Biopharmaceutical Assay Essentials$3,100Register
June 23–25, 2026Fermentation Engineering$3,100Register
June 30–July 2, 2026Hands-On Principles of mRNA Technology$2,500Register
July 8–10, 2026Downstream Biopharmaceutical Processes: Fundamentals and Design$3,100Register
July 14–16, 2026AAV Quality Attributes: Theory and Practice$2,975Register
July 14–17, 2026Hands-On cGMP Biomanufacturing Operations$4,200Register
July 28–31, 2026Hands-On Biomanufacturing of Vectors for Gene Therapy$4,500Register
Aug 6, 2026Design of Experiments for Biomanufacturing$500*Register
Sept 29–Oct 1, 2026Cell Culture Engineering$4,200Register
Oct 13–16, 2026Applied Principles and Techniques of Depth Flow Filtration (DFF) and Tangential Flow Filtration (TFF) for BioPharm Purification$3,995Register
Nov 10–12, 2026PAT for Real-time Culture Monitoring and Closed-Loop Process Control$2,975Register
TBDMicrobial Contamination Control in Bioprocessing Operations$2,975

* $250 for students (if you are a student, email shodge@ncsu.edu to receive a discount code).

Attend and You Will Learn

Participants will gain practical knowledge in the following areas: fundamental statistical concepts for DoE (including hypothesis testing, confidence intervals, statistical modeling, and Analysis of Variance – ANOVA); application of factorial and response surface designs for bioprocess characterization and optimization; interpretation of DoE software outputs (e.g., normal probability plots, interaction plots, contour plots, residual analysis, and ANOVA tables).

Who Should Attend

This workshop is designed for individuals involved in bioprocess development and optimization, especially those with limited experience in DoE methodologies.

What to Bring

Participants should bring their own laptops with JMP software pre-installed (a free 30-day trial is available at www.jmp.com; it is recommended to download and activate it a few days before the workshop).

Instructor

Dr. Marcello Fidaleo is an associate 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 and biotechnology industry.

His research interests include modeling of membrane processes and enzymatic and microbial processes in the area of food, chemistry and 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 NC State’s Department of Chemical and Biomolecular Engineering.

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.

Important Information for Course Participants

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