Upstream Process Development

Day 1-3

• Biochemistry of Cell Growth and Physiology
  • Cell Metabolism, Growth + Product Formation: Science of cell physiology and factors affecting process.
  • Media Formulation: Media as a nutrition source, and a process input.
  • Critical Process parameters: Various process parameters and their effects
  • Modes of Operation: Overview of process modes (batch, fed-batch, perfusion)

Day 4

• Design of experiments
  • Principles of Quality by Design: QbD and other consideration for process knowledge
  • Theory of DOE: Mathematical and Statistical Background
  • Application to screening: Specific Examples/Workshop
  • Application to Optimization: Specific Examples/Workshop

Day 5

• Scale-up
  • Challenges with scale-up: Differences at “bench” and production scale.
  • Measuring across scales: Overview of various metrics used for comparison.
  • Mathematical Approaches: Example of different tools and theories behind scaling.
  • Risk Assessment: Considering Module 2B and options to mitigate risk.

* The course schedule is subject to possible adjustments.

1. Biochemistry of Cell Growth and Physiology

A) Cell Metabolism, Growth + Product Formation: Science of cell physiology and factors affecting process.

B) Media Formulation: Media as a nutrition source, and a process input.

C) Critical Process parameters: Various process parameters and their effects

D) Modes of Operation: Overview of process modes (batch, fed-batch, perfusion)

2. Design of experiments

A) Principles of Quality by Design: QbD and other consideration for process knowledge

B) Theory of DOE: Mathematical and Statistical Background

C) Application to screening: Specific Examples/Workshop

D) Application to Optimization: Specific Examples/Workshop

3. Scale-up

A) Challenges with scale-up: Differences at “bench” and production scale.

B) Measuring across scales: Overview of various metrics used for comparison.

C) Mathematical Approaches: Example of different tools and theories behind scaling.

D) Risk Assessment: Considering Module 2B and options to mitigate risk.

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

• Design and optimize biomanufacturing processes based on measured bioreaction parameters
• Utilize basic principles of Design of Experiment (DoE) for process development
• Identify the main challenges associated with fermentation scale-up and mitigate risks.

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

1. This course is free for PhD students registered at a Danish university
2. The course fee for PhDs registered at international institutions and faculty/staff employed by an academic institution is 7,000 DKK
3. The course fee for industry participants is 15,000 DKK.

To register, please reach out to Program Coordinator,  Khaled Chatila (khachat@dtu.dk). Send your name, university or company and department.

The application deadline is 2 weeks prior to course start.

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

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.