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.
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.
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.
- 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.
Professionals in need of interdisciplinary overview
The course is for professionals in the pharmaceutical industry with occasional or regular contact with producers or departments working with process development, or even wish to enter the field yourself. This course gives you a good insight in the processes, regulations and options for the production of both small molecule and biopharmaceutical drugs.
Participants must
- 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 about the admission criteria.
Course responsible
Associate professor Jesper Langgard Kristensen, University of Copenhagen
Lectures will be held by visiting experts from the industry
This course is offered as an compulsory course in the Master of Industrial Drug Development programme.
Priority is given to students enrolled on Master of Industrial Drug Development. Once the enrolled students have been admitted to the course, the remaining seats are distributed on a first-come, first-served basis.
Course details
| Duration: | 5 days course |
| Dates: | Expected to be offered in autumn 2025 |
| Frequency: | Only available every second year |
| Place: | University of Copenhagen, Copenhagen, Denmark |
| Course fee: |
EU/EEA citizens: DKK 14,450 DKK The fee includes lunch/coffee. |
| Level and credit: | Master's course; 3 ECTS |
| Examination date: | Written examination. Please consult the exam schedule |
| Application deadline: | 8 weeks prior to the course start |
| 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