Course Overview

This course provides an overview of the upstream operations and downstream operations that comprise a typical biopharmaceutical process. Specifically, the course focuses on fundamental concepts, process parameters, and operational considerations for the following processing steps common to most processes: fermentation, centrifugation, chromatography, ultrafiltration, and bulk filling. It also covers basic current Good Manufacturing Practice (cGMP) requirements related to biopharmaceutical manufacturing and incorporates those concepts in the lab activities.
Approximately half of the content is delivered through lecture and discussions, and the other half through hands-on laboratory experiences. The participants will engage in pilot-scale laboratory experiences that examine process utilities, media and solution preparation, bioreactor operation, centrifugation, chromatography, and tangential flow filtration in a simulated commercial cGMP (current Good Manufacturing Practice) facility. The course will take place in the pilot plant facilities at the Department of Chemical and Biochemical Engineering on DTU’s Lyngby campus.

Learning Outcomes

At the end of this course, participants will be able to:

• Describe what cGMP expectations have to be fulfilled in biomanufactoring installations
• Reflect on how to achieve clean process utilities
• Produce sterile media and solutions used for up- and downstream purposes
• Prepare, operate, and clean technical installations like continuously stirred reactors and separation equipment like centrifuges, chromatography systems and cross flow filtration units
• Describe the fundamental background for unit operations in biologics production processes
• Reflect on the monitoring and control of process parameters for meeting production expectations

Who should attend?

The course is broadly applicable to anyone who is interested in learning about large-scale biomanufacturing operations and gaining hands-on experience in a simulated cGMP environment. This course is perfect for new employees, support personnel from Quality Control and Quality Assurance, and vendors and suppliers who provide equipment and services to the industry.

Prerequisites

 
This course is for individuals with background, skills, and/or experience in the following areas:

• New employees in biomanufacturing, including scientists, engineers and operators
• Support personnel who are directly or indirectly involved with the manufacturing process
• Suppliers and vendors of technical equipment used in biomanufacturing
• Workers who are entering to the biomanufacturing industry.