Hands-On Introduction to Biomanufacturing Operations

Day 1

• Lecture 1: Course orientation
• Lecture 2: Biopharmaceutical products and processes
• Lecture 3: Orientation of experiment & documentation
• Lab: Pilot safety and orientation
• Lab: Media preparation for 50 L fermenter, sensor calibration, pressure test, start sterilization
• Lab: Inoculation (Life Bench – Start of PreCulture)
• Lab: Control of Successful Start of Sterilization Process

Day 2

• Lab: Start of Operation and insert process conditions   Preparation of inoculum, inoculation & sampling
• Lecture 4: Cell growth and critical process parameters
• Lecture 5: cGMP bioreactor design
• Lecture 6: Monitoring and control of 50 L fermenter
• Lab: Batch control, Feed connection and start, Induction with IPTG, sample

Day 3

• Lab: Final sampling of 50 L fermenter
• Lab: Harvesting, and Startup of Centrifuge
• Lab: Centrifugation & Cleaning
• Lecture 7: Principles of centrifugation and depth filtration
• Lecture 8: Principles of chromatography
• Lab: Pilot tour
• Lecture 9: Principles of ultrafiltration 

* The course schedule is subject to possible adjustments.

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

• Understand the basis for biomanufacturing processes (upstream and downstream)
• Understand the biomanufacturing process environment (pilot plant)
• Understand the challenges that can arise during biomanufacturing
• Understand the importance of monitoring processes and collecting process data (towards cGMP)
• Understand the vocabulary used in biomanufacturing

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.

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 biomanufactoring
• Workers who are entering to the biomanufactoring industry. Hands-on Microscopy (Tailor-Made Course)

Participants do not need to have specific knowledge in the field of biotechnology other than a basic high-school level understanding of natural sciences.

Here you will find important information for short course participants regarding cancellation policies, location and waitlist policies.

To register for the course please click “Add to basket”.

The registration deadline is 13 October 2023.

In case, you have any questions related to your registration, please contact Course Coordinator Ida Christina Rasmussen idaras@dtu.dk.

The course will take place in the pilot plant facilities at the Department of Chemical and Biochemical Engineering on DTU’s Lyngby campus.

We offer employees in start-up companies, educational institutions and the public sector a 25% course fee reduction. Tick off the relevant boxes in the registration form to apply for this discount. You will get to the registration form when adding the course to the basket.

Companies wishing to arrange a tailored/private course are more than welcome to contact us to discuss this opportunity.

This course was developed in the framework of the AIM-Bio project (Accelerated Innovation in Manufacturing Biologics), in collaboration between DTU Bioengineering, DTU Chemical Engineering, and the Biomanufacturing Training and Education Center (BTEC) at North Carolina State University. The AIM-Bio project is funded by the Novo Nordisk Foundation.

“All presenters showed a great knowledge on the topics presented, not only related to theory but especially practical experience.”

“Intense but good mixture of lectures content and practical visits.”