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Fundamentals of Biomanufacturing

revised course online course

This online course provides a general overview of the production of drug substances for biological products (i.e., substances used in drug products that help prevent or treat human diseases). You'll receive a thorough introduction to biomanufacturing and an overview of each of the main phases in the production process: cell growth, harvest, purification, and formulation/filling.

Delivery methods

Course content

Why should you take this course?

Knowledge of the basic concepts of biomanufacturing will help you to communicate more effectively with subject matter experts and understand why certain unit operations are employed.

Participate and you will learn

This course will introduce you to the following topics:

  • Properties of biological products
  • Regulatory expectations
  • Generating an expression system
  • Modes of bioreactor operation
  • Critical control parameters in upstream bioprocessing
  • Separating cells from growth medium
  • Utilization of chromatography to increase the purity of the target protein
  • Viral clearance steps
  • Formulating and filling drug substances into bulk containers

Course format

This course is self-paced and delivered totally online. After registering, you will have 90 days to complete the course, which is always available (except for brief maintenance periods). You can access materials whenever it's convenient; this course does not include any scheduled meetings or other real-time events. The course consists of 13 modules, each of which has at least one video presentation and an assessment. Many of the modules contains reading assignments, and some contain optional presentations for additional learning opportunities. At a minimum, the course will take three to four hours to complete.

List of modules

This course presents the following topics:

  1. Introduction to biological products and pharmaceutical drugs
  2. Proteins
  3. The four stages of biomanufacturing
  4. Good Manufacturing Practice (GMP)
  5. Expression systems and biotechnology
  6. Nutritional strategies/cell culture media
  7. Cell growth
  8. Bioreactor design, operation, and control
  9. Cell separation: centrifugation and depth filtration
  10. Chromatography
  11. Viral clearance
  12. Ultrafiltration and diafiltration
  13. Bulk filling

Course Preview

See an excerpt from a narrated presentation.

Who should attend

Anyone with some background in chemistry and biology who is interested in obtaining a basic understanding of large-scale biomanufacturing operations. This includes the following:

  • New biomanufacturing employees
  • Biomanufacturing support personnel who may not be directly involved with the process they support
  • Vendors who supply the biomanufacturing industry with equipment and components
  • Incumbent workers seeking to enter the biomanufacturing industry

Register and you will receive

  • All necessary information to access the course website
  • A minimum of three to four hours of instruction, including narrated presentations, readings, and assessments
  • Course certificate upon completing all course assessments

Register now

Fee

$249

Location

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.

Payment

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

Extensions

After registering, you will have 90 days to complete the course, which is always available (except for brief maintenance periods). Requests for extensions beyond the 90 days must be requested within 30 days of course access end date and will be considered on a case-by-case basis. Extensions are limited to one additional 30-day access window.

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 or fax to 919-513-1697.

Cancellation by BTEC

Cancellation by BTEC does not apply to this course.

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.