SMIMM1151U Process Development and Production of Active Pharmaceutical Ingredients (API)

Volume 2026/2027
Education
Content

All relevant subjects related to the chemical process development of biologically active compounds used as pharmaceuticals will be discussed. 

Basic conventions terms and definitions will be discussed. Focus will be placed on scale-up, process optimization, yield considerations, purification, validation, registration, and regulatory approval for new processes.

Various strategies to achieve a safe, more economical, and defensible process will be covered. Other topics that can be covered include: Design of Experiments, route scouting, telescoping, 2nd generation processes, process monitoring, selection of appropriate in-process controls, process analytical technology (PAT), etc.

Examples of process developments will be given both for small molecular compounds and biopharmaceuticals.

Further subjects are quality assurance, GLP and GMP considerations, Quality-by-Design (QbD), environmental considerations, life cycle management, emission limits and monitoring, resource consumption and CO2-emission, safety, hazard and operability, risk assessment and handling excessive reaction conditions.

Learning Outcome

The development of a safe and efficient manufacturing process of an active pharmaceutical ingredient (API) is a substantial undertaking. A successful endeavour requires solving problems within synthetic organic, biochemical, analytical chemistry, engineering, and economics. An understanding of process development and the particular challenges during each phase is the primary focus of this course. A combination of theory and practice using examples from industry and the literature will create the foundation for solid decision-making skills and an understanding of the trade terminology.

Upon completion of the course, students are expected to be able to:


Knowledge

  • The course will make the participants familiar with the terms, principles and methods used in developing a chemical or biological process from discovery to routine manufacturing.


Skills

  • The participants 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.


Competencies
The course provides a solid introduction to working in process development. The successful participant will be able to

  • Closely interact with specialists where process development is a part of the project
  • Identify and explain common risks and problems in process development

Lecture materials will be provided as handouts. In addition, relevant scientific publications will be made available. Case study material will form the basis for discussions.

Furthermore, the textbook Practical Process Research and Development by Neal G. Anderson, Academic Press Inc., U.S., 2000. (ISBN 0-12-059475-7) is recommended for background reading, but purchase of the textbook is optional.

 

It is necessary to understand a basic level of chemistry.
The course comprises lectures, workshops, plenary discussion and problem solving of real-life examples.

Lectures are based upon a combination of selected material from scientific papers and the lecturers' own work and experiences. The workshops encourage the participants to actively propose solutions to challenges that often occur during process development, based on relevant examples from the literature.
  • Category
  • Hours
  • Lectures
  • 20
  • Preparation
  • 50
  • Theory exercises
  • 10
  • Exam
  • 4
  • Total
  • 84
Collective
Continuous feedback during the course of the semester
Credit
3 ECTS
Type of assessment
Home assignment
Type of assessment details
The exam is a set report of 5-10 pages covering 3-5 topics from course, that will be worked on under supervision during the week the course is running, and handed in when the course is over.
Aid
All aids allowed
Marking scale
7-point grading scale
Censorship form
No external censorship
Exam period

See exam schedule.

Re-exam

Same as ordinary.

Criteria for exam assesment

To achieve a grade of 12, the student must be able to:

Knowledge

  • familiar with the terms, principles and methods used in developing a chemical or biological process from discovery to routine manufacturing.


Skills

  • ability 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.


Competencies

  • discuss and explain common risks and problems and provide possible solutions in process development