SFKKA9051U Advanced Manufacturing of Pharmaceuticals

Volume 2013/2014
Education
MSc in Pharmaceutical Sciences - elective, MSc in Medicinal Chemistry - elective, Cand.Scient.Pharm. - elective, Cand.Pharm. - elective
Content
The course will introduce the critical tools needed for future professionals working in drug development and manufacturing of pharmaceuticals. The main goal is to provide students with knowledge required for designing robust medicinal product using Quality by Design (QbD) principles. The course will start by introducing the unit operations used in manufacturing of pharmaceuticals. This part covers primary manufacturing of both small molecules (synthesis and crystallization) as well as macromolecular system (fermentation and related separation technologies), followed by introduction of secondary manufacturing steps (granulation, tableting and coating, as well as spray/freeze drying technologies for macromolecular systems). Theory and practice will be introduced hand in hand with lectures and excursions to local industry. Next phase involves the introduction of central Quality by Design tools - Design of Experiments (DoE) and chemometrics, as well as physical modelling. Students will be introduced to different levels of modelling used in designing robust manufacturing processes – starting from modelling molecular interactions explaining the behaviour of systems with pharmaceutical interest, and proceeding to modelling of process performance based on basic engineering principles. Specific examples of process analytical technologies (PAT) will be discussed with a special focus on analytical tools applicable for the analysis of moving matter.The last part of the course provides deeper insight into the general structure of pharmaceutical quality systems and basic risk management approaches. Basic principles of the plant design of pharmaceutical manufacturing sites will be introduced. For project work, students will work in small groups of 4 students around given formulation/processing example. Project work will be presented during project presentation.
Learning Outcome

Formål / Objective

To provide students with fundamental knowledge related to manufacturing of pharmaceuticals. Participants will gain deeper insight into all critical unit operations of pharmaceutical interest, as well as an introduction to functions of pharmaceutical quality systems and plant design principles. All this will be introduced as a sound combination of lectures and excursions to local industry. The Quality by Design (QbD) approach will be a key element in the course. Design of Experiments (DoE) and chemometrics, as well as physical modelling will be explained through lectures and practical exercises. After finishing the course, students should also be able to use the physicochemical principles to analyse the processability of a given dosage form.

Målbeskrivelse / Course outcome

At the end of the course, students should:
  • Be able to analyse the critical unit operations used in manufacturing medicinal products
  • Understand the importance of formulation design in relation to manufacturing according to Quality by Design (QbD) principles
  • Have insight into pharmaceutical quality systems, risk management techniques and plant design of pharmaceutical manufacturing sites
  • Have acquired skills in performing basic Design of Experiments (DoE) and multivariate data analysis
  • Have acquired skills in applying the general principles of physical modelling related to manufacturing of pharmaceuticals.
Literature
Lecture notes and relevant publications are available from the course homepage
Students are expected to have a good knowledge of basic formulation and processing of dosage forms, as well as an interest in becoming a future specialist in the field of pharmaceutical development.
•Lectures: 32 hours
•Demonstration: 4 hours
•Excursions: 12 hours
•Seminar: 4 hours
  • Category
  • Hours
  • Colloquia
  • 4
  • Excursions
  • 12
  • Lectures
  • 32
  • Practical exercises
  • 4
  • Preparation
  • 78
  • Project work
  • 76
  • Total
  • 206
Credit
7,5 ECTS
Type of assessment
Course participation
Prøveform / Examination type:
Satisfactory participation during the lectures, exercises, project work and project presentation
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assesment
Satisfactory participation during the lectures, exercises, project work and project presentation