EUFEPS
Network on PAT
Powering Science
Based Process Understanding and Quality-by-Design for Medicines
Background
EUFEPS Network on PAT (Process Analytical Technology and
Underpinning Sciences)
Building quality into drug products should commence during the
early phases of research and development. Consideration and
implementation of the quality requirements for new medicines
at these early stages should facilitate effective process development
and robust large-scale manufacture. Process Analytical Technology
(PAT) should therefore play a crucial role in design, analysis,
and control of manufacturing processes based on timely in-process
measurements for integrated system approaches, innovative developments
and cutting edge scientific advances.
At the EUFEPS 2004 in Brussels – for which the overall
theme was New Safe Medicines: Towards Mechanistic Prediction
– there was a session devoted to Revolution in Science
Driving Process Analytical Technology. Those participating in
this session of two and a half days decided to create a European
Network on Process Analytical Technology Science to further
encourage, stimulate and initiate new approaches and interaction,
but also to promote education and training in the field. It
was concluded that both better understanding of chemical and
industrial processes and development of advanced instrumentation
and measurement tools were very much in demand. For a short
summary of the outcome of the EUFEPS 2004 Session, see the December
2005 (4/2005) issue of the EUFEPS
NewsLetter.
EUFEPS has agreed to provide a home for this emerging Network
as well as to facilitate communication including announcement
on the organization of PAT focused meetings and courses.
Current
EUFEPS PAT Network Steering Committee Members
Chair
• Staffan FOLESTAD, AstraZeneca, Mölndal, Sweden
(staffan.folestad@astrazeneca.com)
Vice-chair
• Jukka RANTANEN, Copenhagen University, Copenhagen, Denmark
(jtr@farma.ku.dk)
Secretary
• Thomas DE BEER, Ghent University, Ghent, Belgium (Thomas.DeBeer@UGent.be)
Members-at-large
• Buket AKSU, Santa Farma, Istanbul, Turkey (baksu@santafarma.com.tr)
• Joao ALMEIDA LOPES, University of Porto, Porto,
Portugal (joaolopes@ff.up.pt)
• Marcel DE MATAS, University of Bradford, Bradford,
United Kingdom (m.dematas1@Bradford.ac.uk)
• Jarkko KETOLAINEN, University of Kuopio, Kuopio,
Finland (jarkko.ketolainen@uku.fi)
• Gerd KLEINSCHMIDT, Sanofi-Aventis, Frankfurt, Germany
(Gerd.Kleinschmidt@sanofi-aventis.com)
•Hans H. LINDEN, EUFEPS Central Office, Stockholm,
Sweden (hans.linden@eufeps.org)
• Wim OOSTRA, Organon, part of Schering Plough, The
Netherlands (wim.oostra@spcorp.com)
From left to
right: Thomas De Beer, Jarkko Ketolainen, Hans Lindén,
Wim Oostra, Staffan Folestad, and Marcel De Matas
From top: Jukka
Rantanen, Joao Almedia Lopes , and Buket Aksu
Mission
The EUFEPS Network on PAT (Process Analytical Technology
and underpinning sciences) has been established to create and
maintain a unique and effective forum to encourage and improve
collaboration, actively contribute to education and training,
and to promote innovation in relevant sciences - all to power
science based process understanding and Quality-by-Design for
medicines.
Objectives
of the EUFEPS Network on PAT
The objectives of the EUFEPS Network on PAT include:
