Analytical Methodology in Protein Formulation Development
Provider: Faculty of Health and Medical Sciences

Activity no.: 3136-15-00-00 
Enrollment deadline: 10/09/2015
Date and time12.10.2015, at: 09:00 - 16.10.2015, at: 16:00
Regular seats25
Course fee5,760.00 kr.
LecturersMarco van de Weert
Vito Fodera
ECTS credits4.10
Contact personJanne Steen Kjærulf    E-mail address:
Enrolment Handling/Course OrganiserPhD administration     E-mail address:

Aim and content
Learning objectives
A student who has met the objectives of the course:

a. Will obtain insight into analytical methods to characterize protein physicochemical instability
b. Will be able to describe and understand the advantages and disadvantages of these methods
c. Will be able to explain the mechanistic background of the experimental methods
d. Will be able to relate the information obtained from those methods to the various destabilization mechanisms of proteins
e. Will be able to select appropriate methods to characterize protein pharmaceuticals
f. Will be able to assess the used methods in scientific papers/reports, and propose additional/alternative methods

General information on protein physicochemical instability as relevant for pharmaceutical development will be provided. Several of the most important analytical methods will also be discussed, including mechanistic background, instrumentation, advantages, and disadvantages.

Specifically, lectures will be given on the following topics:
Introduction to proteins in pharmaceutical applications
Introduction to protein structure
Protein physicochemical stability, stabilisation, and formulation
Analytical methods to study protein structure in pharmaceutical formulations (focus on UV-VIS, Fluorescence, CD, and FTIR/Raman spectroscopy, liquid chromatography, scattering methods, and mass spectrometry)
Analytical methods and protein stabilisation in academic and industrial practice

The course is primarily aimed at academic and industrial scientists working on protein formulation development, but may also be of relevance to scientists whose work on proteins is hampered by their physicochemical instability.
Participants are highly recommended to have a prior understanding of basic thermodynamics, protein structure, and analytical chemistry. The course should be considered intermediate to high level.


The course consists of several lectures (ca. 19 hrs), and group work and discussions (ca. 9 hrs).
The examination of the course (pass/fail) consists of a 5-6 page essay in which the participant can either use their own project or a selected scientific paper to illustrate what they have learned during the course. This essay must be submitted ca. 6 weeks after the end of the course.

Course director
Vito Foderà, Assistant Professor, Department of Pharmacy,

Vito Fodera, Assistant Professor, Department of Pharmacy, University of Copenhagen
Marco van de Weert, Associate Professor, Department of Pharmacy, University of Copenhagen
Kasper Rand, Associate Professor, Department of Pharmacy, University of Copenhagen
Jette Kastrup, Professor, Department of Drug Design and Pharmacology, University of Copenhagen
Ted Randolph, Professor, University of Colorado @ Boulder, USA
Wim Jiskoot, Professor, Leiden University, The Netherlands
Tudor Arvinte, Professor, University of Geneva, Switzerland

Course secretary
Janne Kjærulff,

October 12-16, 2015

Course location
Universitetsparken 2 (U9/U10)