Single-Course English 5 ECTS

Pharmaceutical Process Development

Overall Course Objectives

1. Explain the basis for current and most importantly, future pharmaceutical production processes (small and large molecules, generics and biosimilars) and their development.
2. Describe the principles of the QbD/PAT philosophy as defined by FDA, as well as LEAN and GMP.

Learning Objectives

  • Describe the production process for typical small-molecule pharmaceuticals.
  • Describe the production process for typical biopharmaceuticals.
  • Explain the principles of QbD and PAT
  • Describe the development process and ‘life-cycle’ of a new pharmaceutical.
  • Describe the latest developments in the field of pharmaceutical development and production processes.
  • Explain the principles of LEAN manufacturing.
  • Describe the different classes of pharmaceutical, biopharmaceutical, biosimilars and generics.
  • Explain the principles of GMP manufacturing

Course Content

Introduction – future pharmaceuticals with increased complexity; trend towards therapeutic proteins; trend towards continuous processes based on FDA requirements; Small molecule production – future pharmaceutical production, including semi-synthetic approaches (fermentation and biocatalysis) and continuous processes as well as technologies for improved sustainability; Biopharmaceutical production – future biopharmaceutical production, including fermentation, cell culture, antibody processing and downstream processing and single use technology, alternative hosts; Process Development – pharmaceutical process development paradigms; PAT and QbD: Process Analytical Technology (PAT) and Quality-by-Design (QbD), GMP, LEAN.

Teaching Method

Lectures, exercises and group work


See course in the course database.





13 weeks


Chemical Engineering


DTU Lyngby Campus

Course code 28850
Course type Candidate
Semester start Week 5
Semester end Week 19
Days Wed 8-12

7.500,00 DKK