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.
This course is a part of
This course gives you a good insight in the processes, regulations and options for the production of both small molecule and biopharmaceutical drugs. An understanding of chemical development and the particular challenges during each phase is the primary focus.
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.
Course content
We have assembled a unique team of industrial speakers who are experts in process development and production of pharmaceutical ingredients. The course will cover both the theoretic background and give an industrial perspective on modern drug production and regulations.
For more details about the course, please refer to the course curriculum.
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Course director and lecturers on »Process Development and Production of Active Pharmaceutical Ingredients (API)«
Course details for »Process Development and Production of Active Pharmaceutical Ingredients (API)«
Dates and examination
Course dates
1–5 December 2025
The course is available every second year.
Examination
Please find the exam dates in the exam plan.
Learning outcomes
Upon completion of the course, you will be able to:
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understand the terms, principles and methods used in developing a chemical process from discovery to routine manufacturing
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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
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closely interact with specialists and work as project leader where process development is a part of the project
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identify and explain common risks and problems in process development
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compute and critically apply various process metrics.
Admission criteria
You must meet the following criteria to be admitted to this course:
- Hold a relevant bachelor degree or equivalent.
- Have a minimum 2 years of relevant job experience in drug development.
- Be proficient in English.
Find detailed information in the admission criteria on Master of Industrial Drug Development.
Priority is given to enrolled students
This course is offered as a compulsory course in the Master of Industrial Drug Development programme. Priority is given to students already enrolled. Once the enrolled students have been admitted to the course, the remaining seats are distributed on a first-come, first-served basis.
Tuition fees
EU/EEA citizens
14,450 DKK
Non-EU/EEA citizens
16,585 DKK
The fee includes lunch and coffee.
More information
All course information is available in the course curriculum:Faculty of Health and Medical Sciences
Department of Pharmacy and Department of Drug Design and Pharmacology
Universitetsparken 2
DK-2100 Copenhagen
