Upstream Process Development for Biopharmaceutical Production

online course

Delivery Format

Course content

This self-directed course is available to registrants on demand throughout the course dates. One hour of live instructor assistance is provided weekly from 1:00–2:00 p.m. EDT each Friday during the course via Zoom.

upstream course

This course can count toward your Professional Certificate in Biomanufacturing Science.

Why should you take this course?

Development of biopharmaceutical manufacturing processes requires fundamental understanding of basic mechanisms of cell metabolism and cell physiology, integrated with empirical determinations of optimal reactor operating conditions using small-scale experiments and then scaling-up for production.

This online course provides participants with an understanding of the theory and skills needed to make decisions related to upstream process development—and an awareness of how those decisions affect the process. Participants will be introduced to both the theory of Design of Experiments (DOE) and its use as a tool to accomplish activities ranging from process development to production. Course activities include prediction of fermentation performance by yield, titer, and scale-up computations as well as practice using DOE to analyze experimental results.

Participate and you will learn

  • How process parameters can be used to manipulate cell metabolism and physiology, with the goal of optimizing an upstream biomanufacturing process;
  • Basic principles of Design of Experiments (DOE) and the various ways it is used in upstream process development;
  • Various considerations that go into deciding on the final commercial production process for a biopharmaceutical product;
  • Challenges associated with scale-up of upstream processes;
  • The importance of coordinating process development with process scale-up activities;
  • Several approaches to mitigating risk associated with process scale-up.

Who should attend

Scientists and engineers with experience in upstream bioprocessing who are interested in theory and decision-making related to upstream process development.

Participants should have an understanding of recombinant protein production and be interested in an in-depth examination of how media components and bioreactor parameters (and the interactions of those parameters) are chosen to develop scalable production processes. Prior experience in either or both fermentation and cell culture is assumed.

The course is also appropriate for graduate students and faculty working in upstream process development.

Course format and schedule

This online course is self-paced; it does not include any mandatory scheduled meetings or real-time events. However, an instructor will be available online for consultation for one hour weekly during the course.

Instruction is provided through recorded lectures and related exercises on the course website, which can be accessed whenever convenient during the course dates. Upon registration, participants will be provided with instructions for accessing the course website, which is always available except for brief maintenance periods. The course will remain available to participants for 30 days after the course ends.

In addition, an optional week of on-demand learning is available before the course officially begins; this allows participants not already familiar with JMP software to learn the basics needed for the course.

It’s estimated this course takes approximately 20–25 hours to complete, including time to work on the included exercises. Note that although lecture recordings are not downloadable, PDF versions of slides are available to participants.


Once the course begins, participants can complete the on-demand materials at any time as long as they complete all modules by October 31. Each module requires approximately three hours to complete.

NC State's learning management system, Moodle, hosts the on-demand portion of the course, which for modules 1–4 consists of recorded lecture material with interactive elements and related resources (e.g., discussion forums). Upon registration, participants will be provided with instructions for accessing the course website. The Moodle course site will remain available to participants for 30 days after the course ends.

  • Optional Introduction to JMP
  1. Biochemistry of Cell Growth and Physiology
  2. Defining Process Needs
  3. Design of Experiments
  4. Scale-Up


Register and you will receive

  • Approximately 12 hours of instruction (not including the time needed to complete practice exercises)
  • Certificate of completion




Payment by credit card must be made at the time of registration. Prior to registration, please direct any questions to

Pre-course communication

Upon successful registration for a course, you will receive an automatically generated email with information about how to access the online materials. If you do not receive this email within one business day of registering, please contact Serena Hodge, Industry Training Coordinator, at

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.

Short course cancellations


Enrollment may be canceled within 10 business days (minimum two weeks) of the registration, subject to the conditions noted below. A 50% cancellation fee is charged for each registration canceled. Refund of the remainder of the registration price is subject to the following conditions:

  • The course material must not have been accessed by the registrant.
  • The registrant must request the cancellation within 10 business days of the registration.

To cancel a registration and be eligible for a refund of course fees, you must notify BTEC by e-mail to


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 canceled and will receive a full refund of registration fees paid. BTEC is not responsible for participants' costs incurred due to cancellation.