SFKKIF001U Biopharmaceuticals: Formulation of Peptides and Proteins

Volume 2013/2014
Education
MSc in Pharmaceutical Sciences - elective, MSc in Medicinal Chemistry - elective, Cand.Scient.Pharm. - elective, Cand.Pharm. - elective
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:
  1. A general introduction to the production methods used to produce peptides and proteins employing synthesis, microorganisms and mammalian cell cultures.
  2. 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.
  3. 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.
  4. The development of peptide prodrugs and peptide and protein analogues will be covered.
  5. 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.
  6. 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

Formål / Objective

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

Målbeskrivelse / Course outcome

At the end of the course, students are expected to:
  1. Explain the principles of formulation for peptides and proteins
  2. Outline the options for the formulation of peptides and proteins
  3. Explain the most important methods for characterizing drugs based on peptides and proteins
  4. Discuss and elaborate on the scientific literature in the field of peptide/protein formulation
Literature
  • Pharmaceutical formulation of peptides and proteins, S. Frokjaer, L. Hovgaard, and Marco van de Weert, 2012, Taylor & Francis
  • Selected articles and hand-outs available on the course homepage
The main academic prerequisites are a basic understanding of protein structure, organic synthesis, microbiology, thermodynamics (physical chemistry), and analytical chemistry.
•Lectures: 36 hours
•Project work: 28 hours
•Excursions: 4 hours
  • Category
  • Hours
  • Exam
  • 16
  • Excursions
  • 4
  • Preparation
  • 90
  • Project work
  • 96
  • Total
  • 206
Credit
7,5 ECTS
Type of assessment
Course participation
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. Excursions are not compulsory.
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assesment
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.