Kursussøgning, efter- og videreuddannelse – Københavns Universitet

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Kursussøgning, efter- og videreuddannelse

Biopharmaceuticals: Formulation of Peptides and Proteins

Practical information
Study year 2016/2017
Time
Block 1
Programme level Full Degree Master
Full Degree Master choice
ECTS 7,5 ECTS
Course responsible
  • Marco van de Weert (16-776b7c6d7938806b786e6f816f6f7c7e4a7d7f786e38757f386e75)
  • Department of Pharmacy
Course number: SFKKIF001U

Course content

The programme module deals with pharmaceutical issues concerning the formulation of drugs based on peptides and proteins. Students will also gain insight into analytical and production problems as well as the regulatory aspects of registering biotechnological drugs.
The following topics will be dealt with:

A general introduction to the production methods used to produce peptides and proteins employing synthesis, microorganisms and mammalian cell cultures.

Methods for optimizing the chemical and physical stability of peptides and proteins, including an introduction to the analytical methods used for chemical and physical-chemical characterization of these types of drugs.

There will be emphasis on formulation of solutions, suspensions and freeze-dried preparations, and the pharmaceutical formulation aspects of developing vaccines and alternative administration methods are also included.

The development of peptide prodrugs and peptide and protein analogues will be covered.

There will be general description of the documentation necessary for the pharmaceutical-chemical part of a registration application, with focus on the special conditions relevant to biotechnological products.

For project work, students in groups of four to five will draft a development plan for a protein drug from production of the drug (the protein) to registration, with the main focus on (pre-)formulation work. Thus, the project work will include all of the aspects discussed during the course, and must form the subject of a written report to be presented orally.

Learning outcome

With focus on (pre-)formulation, the course describes the development of peptide- and protein-based drugs from production.

 

At the end of the course, students are expected to:

 

Knowledge

  • Explain and discuss the principles of formulation for peptides and proteins
  • Explain and identify important degradation pathways of peptides and proteins
  • Explain and identify the most important methods for characterizing drugs based on peptides and proteins

 

Skills

  • Outline the options for the formulation of peptides and proteins
  • Discuss and elaborate on the scientific literature in the field of peptide/protein formulation

 

Competencies

•   Make a development plan for a peptide or protein formulation

Recommended prerequisites

The main academic prerequisites are a basic understanding of protein structure, organic synthesis, microbiology, thermodynamics (physical chemistry), and analytical chemistry.

Mandatory prerequisites

None,

Sign up

Open for Danish and international guest students. For application details look here: http://sund.ku.dk/uddannelse/andre-uddannelsestilbud/meritstuderende/.

Education

MSc in Pharmaceutical Sciences - elective, MSc in Medicinal Chemistry - elective, Cand.Scient.Pharm. - elective, Cand.Pharm. - elective

Studyboard

Study Board of Pharmaceutical Sciences

Course type

Single subject courses (day)

Teacher

Marco van de Weert, Lene Jørgensen, Hanne Mørck Nielsen, Camilla Foged, Kasper Dyrberg Rand, Vito Foderà, and various industrial lecturers

Duration

1 block

Schedulegroup

B
---- SKEMA LINK ----

Teaching and learning methods

Lectures: 36 hours
Project work: 32 hours
Seminars: 8 hours

Capacity

40 students

Language

English

Literature

  • Pharmaceutical formulation development of peptides and proteins, 2nd ed. S. Frokjaer, L. Hovgaard, and Marco van de Weert, 2012, Taylor & Francis
  • Selected articles and hand-outs available on the course homepage

Workload

Category Hours
Lectures 36
Project work 32
Seminar 8
Preparation 130
English 206

Exam (SFKKIF001U - continuous assessment)

Type of assessment

Course participation
Written assignment
Course certificate:
Report and presentation of project work. Students are expected to actively participate in the learning process, that is, in the lectures and in group work (literature searches, discussions within the group, writing, presenting and defending the report). The students must also participate in a minimum of 30 hrs of lectures and in all group presentations.

An attendance scheme will log sufficient attendance. Active participation requires a signed declaration in the report of all group members that all group members actively participated. The report must follow the guidelines layed out in the description of the group work. All group members must act as opponents to one other group.
Students with insufficient attendance or insufficient contribution in the group work may be given extra assignments, such as written evaluation of the report of other groups or short summaries of lecture notes and/or book chapters on specific topics.

Marking scale

passed/not passed

Criteria for exam assessment

To pass the course the student must be able to:

Knowledge

  • Explain and discuss the principles of formulation for peptides and proteins
  • Explain and identify important degradation pathways of peptides and proteins
  • Explain and identify the most important methods for characterizing drugs based on peptides and proteins

 

Skills

  • Outline the options for the formulation of peptides and proteins
  • Discuss and elaborate on the scientific literature in the field of peptide/protein formulation

 

Competencies

•             Make a development plan for a peptide or protein formulation

Censorship form

No external censorship
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