Content

Upstream Process Development for Biopharmaceutical Production

• Oct. 20–Nov. 2, 2023
• Oct. 18–Oct. 31, 2024

Registration is unavailable at this time.

Delivery methods

	40% Lecture
	60% Discussion/group activity

Course content

	70% Fundamentals and concepts
	30% Industry applications

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Upstream

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

Why should you attend?

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 will include prediction of fermentation performance by yield, titer and scale-up computations as well as practice using DOE to analyze experimental results.

Attend 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 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 the area of upstream process development.

Course format and schedule

This online instructor-driven 14-hour course (with an additional 10-15 hours to work on exercises independently) is delivered via a blended live and on-demand format. This format mixes approximately 6 hours of online content designed for independent, self-paced learning with eight hours of instructor-led training across six live sessions.

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.

ON-DEMAND MATERIALS

Once the course begins, participants can complete the on-demand materials at any time so long as they complete each assigned module by the date specified (listed below). 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.

LIVE SESSIONS

This course provides eight hours of live instruction spread over six sessions. There is a one-hour course introduction session. Because the live sessions feature active participation and discussion, participants are expected to complete the assigned on-demand modules in advance of each session. These sessions will be led by the instructors via Zoom on dates to be determined. Ample time will be provided for questions during each session.

Important: To ensure the privacy of participants, live sessions will NOT be recorded. Therefore, participants unable to attend at the dates and times specified will miss those sessions.

Week 0

• Session #1 Friday, October 20, 1 p.m. - 2 p.m. EDT (1 hour). This session introduces the course, its instructors, and the website hosting the self-paced lecture materials.

Week 1

• Session #2 Monday, October 23, 1 p.m. - 2:30 p.m. EDT (1.5 hours). Workshop topic: Characterization of the cell growth process.
• Session #3 Wednesday, October 25, 1 p.m. - 2 p.m. EDT (1 hour). Workshop topic: Evaluation of product run costs.
• Session #4 Friday, October 27, 1 p.m. - 2:30 p.m. EDT (1.5 hours). Workshop topic: Design of Experiments (DOE) screening design and analysis (first of two sessions).

Week 2

• Session #5 Tuesday, October 31, 1 p.m. - 2:30 p.m. EDT (1.5 hours). Workshop topic: DOE screening design and analysis (second of two sessions).
• Session #6 Thursday, November 2, 1 p.m. - 2:30 p.m. EDT (1.5 hours). Workshop topics: Process scale-up and course summary.

Instructors

• Charlie Rutter, Ph.D.
• Laurie Overton, M.S.
• Hunter Brown
• Kurt Selle, Ph.D.

Register and you will receive

• Approximately 14 hours of instruction
• Certificate of completion

Fee

$2,000

Payment

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

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 shodge@ncsu.edu.

If a course is full: Waitlist policy

If a course you want to take is already full, you are welcome to email mswoodya@ncsu.edu 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

CANCELLATION BY REGISTRANT

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 mswoodya@ncsu.edu.

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