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).

Fee

$249

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