Course English

Hands-On Introduction to Biomanufacturing Operations

Want to gain a fundamental understanding of up- and downstream operations that comprise a typical biopharmaceutical process?

The objective of this course is to introduce bioprocess and biomanufacturing concepts for employees. The focus will be on the production process for biomanufacturing. Both microbial-based processes (fermentation) as well as mammalian cell-based (cell-culture) will be discussed, and the differences emphasized.

A key element of the course is to give practical fermentation experience in the pilot facilities at DTU. Course participants will be given guidelines but allowed freedom to operate (hands-on) fermentation at 50 L scale. In the pilot, for simplicity GFP (green fluorescent protein) expressed in E. coli will be used.

The practical part includes the upstream part as well as the cell harvest by centrifugation. Relevant downstream unit operations for product capture and purification will be covered in lectures.

Course schedule

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.

Learning outcomes

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

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.

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)

Prerequisites 

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

Important information 

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

Registration and location 

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

The registration deadline is 2 weeks prior to course start.

In case, you have any questions related to your registration, please contact Course Coordinator Khaled Chatila (khachat@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.

Discount for start-ups and academics

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.

The AIM-Bio project – funded by the Novo Nordisk Foundation

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.

Testimonials

“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.”

Course instructor

Registration

Duration

3 days

Place

DTU Lyngby Campus

Buy

See available discounts at the bottom of the page

Price

24.000,00 DKK

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