Process Development and Production of Active Pharmaceutical Ingredients (API)

Course 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.

Education

Master's Programme in Industrial Drug Development - compulsory

Compulsory for Master of Industrial Drug Development (MIND) students, elective for other part-time master's students at the Faculty of Health and Medical Sciences (subject to study board approval) and open for freelance students who meet the admission criteria.

The course is intended for drug development professionals with contact to chemical process development.

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 successful completion of the course, participants are expected 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

The course is organized as an 5-day course comprising 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.

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.

Applicants must meet the following criteria:
• A bachelor's degree, a professional bachelor’s degree, a diploma degree, a master’s degree or equivalent within chemistry, biochemistry, pharmacy, medicine, biomedicine, human biology, molecular biology, veterinary sciences, health sciences, nursing, engineering or equivalent.
• At least two years of relevant work experience related to development of medicines
• Proficiency in English

Collective
Continuous feedback during the course of the semester
ECTS
3 ECTS
Type of assessment
Home assignment
Type of assessment details
The exam is a 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

Announced on the MIND programme's webpage

Re-exam

The exam form for the reexam is the same as the ordinary exam. Se dates in the examplan on the MIND programme's webpage

Criteria for exam assessment

The examination will monitor the knowledge, skills and competences of the participants using the following criteria:

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

Part time Master and Diploma courses

  • Category
  • Hours
  • Lectures
  • 20
  • Preparation
  • 50
  • Theory exercises
  • 10
  • Exam
  • 4
  • English
  • 84

Kursusinformation

Language
English
Course number
SMIMM1151U
ECTS
3 ECTS
Programme level
Part Time Master
Placement
Autumn
5 days
Price

Fees are published on the programme's homepage at  https://mind.ku.dk/tuition/ Fee includes course materials and lunch/coffee. Prices may be subject to change.

 

Schedulegroup
See course calendar
Capacity
32 participants
Studyboard
Study Board for the Professionel Master´s Degree Programmes at The Faculty og Health and Medical Science
Contracting department
  • Department of Drug Design and Pharmacology
Contracting faculty
  • Faculty of Health and Medical Sciences
Course Coordinators
  • Jesper Langgaard Kristensen   (17-6f6a78756a773370776e78796a73786a7345787a736933707a336970)
  • Rasmus Prætorius Clausen   (3-78676946797b746a34717b346a71)
Teacher

Anas Al-Khawaja, AGC Biologics, Caspar Christensen, Ascendis Pharma and other representatives from Danish Companies working with API development.

Saved on the 04-04-2024

Are you BA- or KA-student?

Are you bachelor- or kandidat-student, then find the course in the course catalog for students:

Courseinformation of students