Introduction to Design of Experiments (DoE)
for Bioprocess Analysis and Optimization


Delivery methods

Course content

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
  • Lunch
  • 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.




All courses are offered on site at BTEC, other than online courses. The Golden LEAF BTEC building is located at 850 Oval Drive on NC State University's Centennial Campus.

If a course is full: Waitlist policy

If a course you want to take is already full, you are welcome to email and ask to be placed on a waitlist for that course. The waitlist is used to fill any seats that become available when individuals registered for the course are unable to attend. If one or more seats become available, individuals on the waitlist are contacted in the order in which they were added to the list.

In addition to ensuring popular courses remain full, waitlists provide a means of tracking interest and determining if additional sessions are necessary. BTEC makes every effort to schedule additional course offerings if sufficient people are wait-listed. If a new offering is scheduled, those on the waitlist are notified before registration opens to the public.

Placement on a waitlist does not commit individuals to attending a course. It simply ensures that they are given first opportunity to enroll if a seat becomes available in a full course and that they are among the first to know if an additional course offering is scheduled during the current year.

BTEC is unable to provide information about the number of those wait-listed for any given course or an individual’s place on such a list.


BTEC strongly prefers payment by credit card at the time of registration. BTEC accepts payment from all major credit cards including American Express, Visa, and MasterCard. If you are not paying by credit card at the time of registration, please email to make arrangements immediately after registering and note the following:

  • If you wish to pay by PO or company check, please note that payment is due within 10 days of registration. If paying by PO, please reference PO number in your email, but note that a PO number will not hold a seat.
  • If no payment has been received within 10 business days of registration, BTEC reserves the right to cancel registration based on enrollment demand.
  • BTEC will add a $75 processing fee to the total cost of the course for all PO or company check payments.

Any additional questions prior to registration should be directed to

Discounts available

A 20% discount is available to:

  • Employees of BMF companies
  • Groups of five or more from one company registering for the same offering of this course
  • Individuals registering for more than one course at a time
  • Faculty/staff working in academic environments

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.

Cancellation policies

Cancellation by registrant

To cancel a registration and be eligible for a refund of course fees, you must notify BTEC by e-mail to or fax to 919-513-1697. Fees are refunded according to the following schedule:

  • 100% refund – If notification is received at least 15 business days in advance of course start date
  • 75% refund – If notification is received 10–14 business days in advance of course start date
  • 50% refund – If notification is received 6–9 business days in advance of course start date
  • No refund will be issued if notice is received 5 or fewer business days in advance of course start

Substitutions may be made up to two business days prior to the course start date. Notify the BTEC office by fax at 919-513-1697 or by e-mail to Please include the name and email contact for the replacement. Please note that BTEC is unable to honor substitutions for individuals taking discounted courses as part of the professional development certificate program.

Cancellation by BTEC

BTEC retains the right to cancel a professional development short course no less than 10 business days in advance of the scheduled course start date. Registrants will be notified by BTEC if a course is cancelled and will receive a full refund of registration fees paid. BTEC is not responsible for airfare penalties or other costs incurred due to cancellation.

Pre-course communication

Upon successful registration for a course, you will receive an automatically-generated email as well as another email from Melody Woodyard confirming your registration. If you do not receive these emails within two business days of registering for a course, please email to confirm your registration.

Once registered, confirmed course participants will receive an email approximately three weeks before the scheduled course with detailed information regarding travel to BTEC, parking information, and a short pre-course questionnaire.