Graduate School of health and Medical Sciences

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

Activity no.: 3136-13-00-00	There are no available seats
	Enrollment deadline: 28/09/2013

Date and time	21.10.2013, at: 09:00 - 25.10.2013, at: 16:00
Regular seats	31
Course fee	6,120.00 kr.
Lecturers	Marco van de Weert
ECTS credits	4.00

Contact person	Janne Steen Kjærulf E-mail address: janne.kjaerulff@sund.ku.dk

Enrolment Handling/Course Organiser	PhD administration SUND E-mail address: phdkursus@sund.ku.dk

Aim and content Course objectives The course objectives are to give participants an insight into the analytical techniques used to evaluate the formulation design of protein-based drugs. General contents and topics General information on protein physicochemical instability and analytical methods to determine this instability, and methods to increase stability. Introduction to proteins in pharmaceutical applications Introduction to protein structure Protein physicochemical stability, stabilisation, and formulation Lyophilisation Analytical methods to study protein structure in pharmaceutical formulations (focus on Fluorescence, CD, and FTIR spectroscopy, HPLC and mass spectrometry) Analytical methods and protein stabilisation in academic and industrial practice General information The 5-day course comprises approximately 10 lectures by an international panel of specialists. The participants will be actively involved in the teaching programme. In small groups (4-5 persons) the participants will be asked to discuss the various analytical techniques and their application in protein analysis with a focus on pharmaceutical formulation. Course material: Selected papers and handouts of the presentations (if possible). The book "Methods for structural analysis of protein pharmaceuticals" (AAPS PRESS) will be handed out to the participants during the course. The participants are also requested to prepare a poster discussing their own research, with particular emphasis on the analytical challenges in their project. Actual data is not required, and the participant may also choose to use a published paper that illustrates the challenges in their own project. The posters will be used in the group work. As a final course evaluation, all participants are required to write a 5 to 6 page essay on a selected subject after the course which is submitted to the course directors within 6 weeks after the course. The essay will be evaluated by the two course directors. The participant may suggest a topic related to their own research subject.

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