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.

Fee

$399

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. Instruction is provided through recorded lectures that may be accessed whenever convenient. 

After registering, you will have 90 days to access the materials on the course website, which is always available except for brief maintenance periods. It’s estimated that the course will take approximately 20 hours to complete. Note that although lecture recordings are not downloadable, PDF versions of slides are available to participants.

Labs 3 and 4 require access to JMP, which is offered in a thirty day trial only. Unless you have alternative access to JMP through a personal or organizational license, we recommend only starting your trial once you are ready to complete Labs 3 and 4. 

Modules

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. 

1. Biochemistry of Cell Growth and Physiology
2. Defining Process Needs
3. Design of Experiments
4. Scale-Up

Instructor

• Miles Calzini, Ph.D.

Register and you will receive

• All necessary information to access the course website
• Approximately 12 hours of instruction and activities
• Certificate of completion