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.
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.
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
Application deadline is 8 weeks before the first day of instruction.
- 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. See dates in the exam schedule 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 (17-76717f7c717e3a777e757f80717a7f717a4c7f817a703a77813a7077)
- Rasmus Prætorius Clausen (3-8271735083857e743e7b853e747b)
Teacher
Anas Al-Khawaja, AGC Biologics, Caspar Christensen, Ascendis Pharma and other representatives from Danish Companies working with API development.
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