Course English

cGMP for Biomanufacturing Operations

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

This course provides an overview of the up- 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
  • Tangential flow filtration in a simulated commercial cGMP (current Good Manufacturing Practice) facility.

Learning outcomes

At the end of this course, participants should 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
  • 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 biomanufactoring
  • Workers who are entering to the biomanufactoring industry. 

Important information 

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

Fee, registration and location 

Fee: DKK 22,000

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

The application deadline is August 12th 2023.

In case, you have any questions related to your registration, please contact Course Coordinator Karina Laurberg Knudsen on klakn@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.

Course instructor

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Duration

14-16 August 2023 from 8:30-16:30

Place

In-person on DTU Campus in Lyngby

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See available discounts at the bottom of the page

Price

22.000,00 DKK

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