Content

Fundamentals of Biopharmaceutical Manufacturing

revised course online course

This online course introduces biopharmaceuticals (also referred to as biological products) and provides an overview of the processes used for their production as well as the regulatory framework that governs their manufacturing. It offers a detailed look at biopharmaceutical manufacturing, covering both upstream and downstream operations. The course focuses on the four stages required for production: cell growth/product synthesis (upstream), product harvest, purification, and formulation/filling (downstream).

Delivery methods

Course content

Why should you take this course?

If you are seeking a clear overview of biopharmaceuticals and their production, this course—designed by a team of experts—delivers exactly what you need. Plus, its online format allows you to learn at your own pace.

Participate and you will learn

This course will introduce you to the following topics:

  • Types and properties of biopharmaceuticals
  • Regulatory expectations for biopharmaceutical manufacturing
  • Generating an expression system
  • Cell banking
  • Steps of cell growth
  • Bioreactor design and modes of operation
  • Control parameters in upstream bioprocessing
  • Centrifugation and depth filtration for solid-liquid separations
  • Cell lysis method for recovery of intracellular products
  • Utilization of chromatography to increase the purity of products
  • Viral clearance steps and why they are required
  • Ultrafiltration for product concentration and buffer exchange
  • Filling drug substance

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 six modules, each of which includes text, media such as photos, graphics and video, interactive features and an assessment. At a minimum, the course will take approximately six hours to complete.

List of modules

This course presents the following topics:

  1. Introduction to biological products and pharmaceutical drugs
  2. Proteins
  3. Overview of biopharmaceutical processes
  4. current Good Manufacturing Practice (cGMP)
  5. Upstream processing of biopharmaceuticals
  6. Downstream processing of biopharmaceuticals

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
  • Approximately six 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.