SMIMM1141U Chemical Process Development and Production of Active Pharmaceutical Ingredients (API)

Volume 2015/2016
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.

Content

All relevant subjects related to the chemical process development of biologically active compounds used as pharmaceuticals will be discussed. The course will begin with the discovery synthesis and end with the full-scale production process.

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 to be covered include: Design of Experiments, route scouting, telescoping, 2nd generation processes, process monitoring, selection of appropriate in-process controls, process analytical technology (PAT), thermogravimetric analysis, reaction calorimetry, and differential scanning calorimetry.

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) 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. 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.

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 have the necessary knowledge in the area to

  • Closely interact with specialists and work as project leader where process development is a part of the project
  • Identify and explain common risks and problems in process development
  • Compute and critically apply various process metrics
Literature

The syllabus corresponds to about 200 pages in the textbook Practical Process Research and Development by Neal G. Anderson, Academic Press Inc., U.S., 2000. (ISBN 0-12-059475-7). In addition, 2-3 case studies reported in current journal articles will be subject to analysis. Lecture materials will be provided as handouts. Purchase of the textbook is optional; however, process chemists will find the text highly useful in their daily work.

Applicants must meet the following criteria:
• A relevant bachelor degree or equivalent
• A minimum of 2 years of relevant job experience
• Proficiency in English
It is necessary to understand a basic level of chemistry.
The course is organized as an intensive 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 the textbook, 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 found in the current literature.
  • Category
  • Hours
  • Exam
  • 2
  • Lectures
  • 20
  • Preparation
  • 50
  • Theory exercises
  • 10
  • Total
  • 82
Credit
3 ECTS
Type of assessment
Written examination, 2 hours under invigilation
Examination design: The examination consists of a multiple choice test and of 1-2 literate problems based on a case story.
Aid
All aids allowed

Apart from the standard programs and IT tools listed under The Faculty of Health and Medical Sciences at http://pc-exam.ku.dk/it_tools/health/ students will at this exam also have access to use a USB stick (for notes etc.)
 

Marking scale
7-point grading scale
Censorship form
External censorship
Exam period

Examination 8 April 2016 at 3-5 p.m.

Re-exam

Reexamination 9 May 2016.

Criteria for exam assesment


The grade 12 is given when the examinee

- gives a well structured presentation with a clear outline providing exact and correct answers
- demonstrates aplomb comprehensive view and combines convincingly the learned elements
- demonstrates with few unimportant deficits: Aplomb mastering of relevant terms, principles and methods used for developing a process from discovery to production.

The grade 7 is given when the examinee

- gives a coherent presentation providing understandable unambiguous answers, the great majority of which should be correct
- documents a certain overview over the learned elements and with minor deficits demonstrates a firm knowledge of relevant terms, principles and methods used for developing a process from discovery to production.

The grade 02 is given when the examinee

- gives a less structured presentation with less precise answers. The overview is limited and the ability to combine learned elements is limited
- only to a limited extent and with a number of deficits demonstrates capability to handle relevant terms, principles and methods used for developing a process from discovery to production.