Biopharmaceuticals: Formulation of Peptides and Proteins

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 by synthesis.

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 and freeze-dried preparations, and the pharmaceutical formulation aspects of developing vaccines and alternative administration methods are also included. Unwanted immunogenicity and pharmacokinetics of protein drugs will be discussed.

The development of 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.

Education

MSc Programme in Pharmacy or Pharmaceutical Sciences (Danish programmes cand.pharm and cand.scient.pharm) - elective

MSc Programme in Medicinal Chemistry - elective

MSc Programme in Pharmaceutical Sciences (English programme) - elective

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

Lectures: 34 hours
Project work: 34 hours
Seminars: 8 hours

  • 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

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

Oral
Collective
Peer feedback (Students give each other feedback)
ECTS
7,5 ECTS
Type of assessment
Course participation under invigilation
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 28 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
Censorship form
No external censorship
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

Single subject courses (day)

  • Category
  • Hours
  • Lectures
  • 34
  • Project work
  • 34
  • Seminar
  • 8
  • Preparation
  • 130
  • English
  • 206