30 May 2023

Process Development and Production of Active Pharmaceutical Ingredients (API)

Understand the theoretic background and the industrial perspectives on modern drug production and regulations from discovery to routine manufacturing. 

Process Development and Production of API

An understanding of chemical development and the particular challenges during each phase is the primary focus of this course. A combination of theory and practice using fresh examples from industry and the literature will create the foundation for solid decision-making skills and an understanding of the trade terminology.

The development of a safe and efficient manufacturing process of an active pharmaceutical ingredient (API) or bulk drug substance is a substantial undertaking. A successful endeavour requires solving problems within synthetic organic, bioorganic, physical organic, analytical and environmental chemistry, engineering, and economics.














  • Upon completion of this course you will be familiar with the terms, principles and methods used in developing a chemical process from discovery to routine manufacturing.
  • You will be able to discuss different aspects and solutions to problems in a broad range covering scale-up, organization, planning, process monitoring, validation, life cycle management, registration, resource consumption, environmental and safety issues.
  • You will be able to closely interact with specialists and work as project leader where process development is a part of the project.
  • You will have learned how to identify and explain common risks and problems in process development.
  • You will be able to compute and critically apply various process metrics.










































Course details

Duration: 4 days course
Dates: 30 May - 2 June 2023; and examination 6 June 2023 
Frequency: Only available every second year
Place: University of Copenhagen, Copenhagen, Denmark
Course fee:

EU/EEA citizens: 12,900 DKK
Non-EU/EEA citizens: 14,985 DKK

The fee includes lunch/coffee.

Payment conditions

Level and credit: Master's course; 3 ECTS
Examination date: Written examination. Please consult the exam schedule
Application deadline: 3 April 2023
Admission: To be admitted, you must meet the admission criteria for Master of Industrial Drug Development

Course dates and application deadlines are announced via the  programme newsletter.
Download course curriculum