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Upstream Process Development


Technical University of Denmark


General course objectives:
This course aims to provide participants with an understanding of the theory and skills needed to make decisions related to upstream process development and an awareness of how those decisions affect the process. Participants will be introduced to both the theory of design of experiments (DoE) and its use as a tool to accomplish activities ranging from process development to production.

Learning objectives:
A student who has met the objectives of the course 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.
  • Analyze critical process parameters and their impact on bioprocess outcomes.
  • Apply knowledge of cell physiology to optimize product formation in bioprocesses.
  • Apply media formulation as a strategic tool for enhancing bioprocess efficiency.
  • Utilize mathematical and statistical tools to perform advanced data analysis in bioprocess development.
  • Evaluate and select appropriate scaling strategies for bioprocesses based on key performance metrics and risk assessments.

Contents:
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.

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Course organizer
Jose Luis Martinez , John Michael , Krist Victor Bernard
Place/Venue
Anker Engelunds Vej 1
City
2800 Kgs. Lyngby
Country
Denmark
Workload
2.5
Link
http://kurser.dtu.dk/course/27828