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

Activity no.: 3136-18-00-00 
Enrollment deadline: 01/02/2018
Date and time12.03.2018, at: 08:30 - 16.03.2018, at: 16:30
Regular seats25
Course fee5,520.00 kr.
LecturersVito Fodera
ECTS credits4.10
Contact personJanne Steen Kjærulf    E-mail address: janne.kjaerulff@sund.ku.dk
Enrolment Handling/Course OrganiserPhD administration     E-mail address: phdkursus@sund.ku.dk

Aim and content
This course is free of charge for PhD students at Danish universities (except Copenhagen Business School). All other participants must pay the course fee.
Anyone can apply for the course, but if you are not a PhD student, you will be placed on the waiting list for the course until enrollment deadline. After the deadline of enrollment, available seats will be allocated to students on the waiting list.

Learning objectives
A student who has met the objectives of the course:

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

Content
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

Participants
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.

Relevance to graduate programmes
The course is relevant to PhD students from the following graduate programmes at the Graduate School of Health and Medical Sciences, UCPH:

Pharmaceutical Sciences (Drug Research Academy)

Language
English

Form
The course consists of several lectures (ca. 20 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, Associate Professor, Department of Pharmacy, vito.fodera@sund.ku.dk

Teachers
Vito Foderà, Associate 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

Dates
12/03/2018-16/03/2018
Course location
Universitetsparken 2 (Benzon auditorium, U10/U11, U23)

Registration
Please register before 01/02/2018

Seats to PhD students from other Danish universities will be allocated on a first-come, first-served basis and according to the applicable rules.
Applications from other participants will be considered after the last day of enrolment.

Note: All applicants are asked to submit invoice details in case of no-show, late cancellation or obligation to pay the course fee (typically non-PhD students). If you are a PhD student, your participation in the course must be in agreement with your principal supervisor.

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