Biopharmaceuticals: Formulation of Peptides and Proteins

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.