Course English

Process Analytical Technology for Biomanufacturing

Are you working in the pharmaceutical industry and are you looking for novel measurement techniques for collecting data?

This compact three-day course surveys visionary aspects of modern and future GMP (Good Manufacturing Practice) methods. It includes QbD (Quality by Design) and PAT (Process Analytical Technology), as these technologies are gaining more and more ground in the pharmaceutical industry. However, the main focus is on models, data, and novel measurement techniques for collecting data.

Data form the basis for model identification and validation, and novel sensors allow to significantly expand the number of variables that can be measured on-line or at-line on a bio manufacturing process. Different modelling frameworks, varying in terms of complexity, can be applied to such data.

During this course, you will be introduced to:

  • Model supported process prediction, including computational fluid dynamics (CFD) methods for design space descriptions
  • The concept of digital twins for the potential use in batch or continuous production processes.
  • Virtual processes and laboratories for process understanding and operator training
  • Basic concepts of Artificial Intelligence (AI) and machine learning algorithms to transform data to actionable information.

The course is intended for participants familiar with classical GMP procedures who want to learn about modern and future trends in QC methods.

Available discounts
Please note, that we offer employees in start-up companies, educational institutions and the public sector a 25% course fee reduction – see more under ‘Discount for start-ups and academics’ below.

Course schedule

Day 1

  • Introduction to PAT and QbD concepts
  • PAT and QbD – practical examples
  • Measurement and sensor devices – novel developments
  • Case studies – particle size distribution measurements, crystallization, flocculation, …

Day 2

  • Model supported process validation – uncertainty and sensitivity analysis
  • Uncertainty and sensitivity analysis – short hands-on session
  • QC Meets production – Novel analysis methods using computational fluid dynamics methods for prediction of concentration gradients
  • Software sensors
  • Software sensors, short hands-on session + discussion

Day 3

  • Application of Digital Twins for unit operations + process control basics
  • Tour of DTU Pilot Plant / equipment demonstration
  • Digital Twins for processes – applications

* The course schedule is subject to possible adjustments.

Learning Outcomes

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

  • Describe novel digital methods and their potential use in a GMP environment
  • Identify opportunities for improved data collection on an existing process, including the use of novel measurement techniques
  • Interpret the results of CFD simulations for visualization of gradients and flow patterns
  • Describe basic concepts of software sensors, digital twins for unit operations and processes and identify the benefits of such model supported tools

Who should attend?

The course is intended for participants familiar with classical GMP procedures who want to learn about modern and future trends in QC methods. The course material is perfect for new employees, support personnel from Quality Control and Quality Assurance, and vendors and suppliers providing equipment and services to the industry. The course addresses all levels of education, including technicians, BSc and MSc.

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

  • Employees in biomanufacturing currently working with GMP who want to get more familiar with current trends in the field
  • Scientists, engineers and technicians who are working with monitoring and control of bio-based manufacturing processes
  • Vendors of auxiliary equipment for the bio-manufacturing industry
  • Employees handling data management aspects of biomanufacturing operations
  • Participants with a background in bio-based production holding a BSc, MSc or PhD degree.


Participants must have a laptop/computer where it is possible to install software or already have an installed modern web. We assume participants have basic knowledge about the general principles of biomanufacturing and downstream operations. Participants are expected to bring a laptop to work with case study examples.

Important information 

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 2 weeks prior to start.

In case, you have any questions related to your registration, please contact Course Coordinator Khaled Chartila (

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 FBM initiative – funded by the Novo Nordisk Foundation

This course was developed in the framework of the Fermentation Based Biomanufacturing Initiative, in collaboration between DTU Bioengineering, DTU Biosustain, and DTU Chemical Engineering. The project is funded by the Novo Nordisk Foundation.

Course instructors



3 days


DTU Lyngby Campus


See available discounts at the bottom of the page


21.000,00 DKK