Continuous Innovation
in Process Analytics & Control

May 9-10 • 2012 • NH Hotel Ghent Belfort • Ghent • Belgium

pdf-symbol Download Final Programme
Download 1st Announcement
Download 2nd Announcement
Pre-EuPAT 5 workshop programme
May 8, 2012, Ghent, Belgium
Organised by Ghent University
 


Please click here for on-line registration
(EuPAT 5 and pre-conference workshop)

   
To read PDF files you will need the software plug-in Acrobat Reader, which is a free shareware from Adobe. Click here if you wish to download the shareware.

Invitation to Join EuPAT 5
The topic of EuPAT 5 – Continuous Innovation in Process Analytics & Control – underlines the importance of bringing innovation into pharmaceutical manufacturing based on QbD and PAT sciences. Building quality into drug products should commence during the early phases of research and development and sustain during the product and process life cycle. Consideration and implementation of the quality requirements for new medicines should facilitate effective process development and robust large-scale manufacture. Advanced process analytics 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.

This is to invite you to attend the fifth pan-European Science Conference on QbD and PAT Sciences, building on the successes of the EuPAT conference series that started in 2006. EuPAT 5 will be held on May 9-10, 2012, in Ghent, Belgium, and organised back-to-back to a training day on “continuous pharmaceutical manufacturing of solid dosage forms”, to be held on May 8, 2012, at the Faculty of Pharmaceutical Sciences from the University of Ghent. The attendees of EuPAT 5 are welcome to register to the pre-conference day and vice versa.

Topics of EuPAT 5
• Continuous pharmaceutical processing
• PAT in bio-active pharmaceutical processing
• Advanced process sensors for control
• Process modeling for in-depth understanding and control
• Material characterization and understanding at molecular level in (bio)process environment

Podium and Poster Presentations
In addition to the podium lectures from recognized leaders in the field, researchers will be given the opportunity to present the latest advancements in QbD & PAT sciences. Based on the submitted abstracts a number of authors are invited to present their research orally.

EuPAT 5 Final Program

Wednesday, May 9, 2012 (8.00 – 18.00)
8.00-8.30 Registration
8.30-8.45 Opening
  Invited Lectures
8.45-9.20 Modeling of Pharmaceutical Processes in the Context of Continuous Manufacturing
Prof. Dr. Johannes Khinast, Technical University of Graz, Austria
9.20-9.55 Process Tomography for Imaging of Pharmaceutical Manufacturing Prof. Dr. Wuqiang Yang, University of Manchester, United Kingdom
  Oral Presentations
9.55-10.15 NIR Multipoint Spectroscopy and Chemical Imaging as PAT and Research Tools in the Optimization and Analysis of Continuous Pharmaceutical Manufacturing Process
Maunu Toiviainen, VTT, Finland
10.15-10.35 Application of In-line Particle Size Measurements for Advanced Process Control of Roller Compaction Processing
Lubomir Gradinarsky, AstraZeneca, Sweden
10.35-11.05 Break & Posters
11.05-11.25 Real-time Monitoring of Granulator Torque to Identify the Steady State Phase of a Continuous Wet Granulation Process: Observation of an Unexpectedly Long Start-up Phase
Gunnar Haeffler, AstraZeneca, Sweden
11.25-11.45 In-Depth Analysis of Multiple Logged Process Parameters during a Continuous Granulation and Drying Process
Jurgen Vercruysse, Ghent University, Belgium
11.45-12.05 Real-time Tablet Formation Monitoring with Ultrasound Measurements in Eccentric Single Station Tablet Press
Jari T.T. Leskinen, University of Eastern Finland, Finland
12.05-13.00 Lunch & Free Poster Session
13.00-13.45 Interactive Poster Presentations
 

Parallel Session I

1. Printing as a Flexible Tool for Manufacturing of New Products for Diagnostics and Drug Delivery Systems
Maria Smolander, VTT, Finland

2. How to Create a PAT Data Management Platform to Support Continuous Production?
Kjell François, Siemens, Belgium

3. Comparison of Granulation Methods: Preparation of Paracetamol Granules by Fluidized Bed, High Shear and Continuous Wet Granulations
Maiju Järvinen, University of Eastern Finland, Finland

4. Validation of Powder Mixing Process using Capacity Index
M. Llabrés, Universidad de la Laguna, Spain

5. Continuous Production of Solid Biodrug Formulations by Electrospinning
I. Wagner, Budapest University of Technology and Economics, Hungary

 

Parallel session II

1. A New Trend for NIR Spectroscopy: In-situ Monitoring of Dissolution Tests
Raquel Figueiredo, Universidade do Porto, Portugal

2. Powder Handling in Pharmaceutical Processes – Innovation or Perpetuation?
R.J. Farnish, University of Greenwich, United Kingdom

3. Comparison between Multipoint NIR Spectroscopy and DEM Simulations via a Water Spray Process
R. Hohl, Research Center Pharmaceutical Engineering GmbH, Austria

4. PAT Based Control for a New Manufacturing Drug Substance Process
Cédric Schaefer, UCB Pharma, Belgium

5. Application of Model Uncertainty Analysis on the Modelling of the Drying Behaviour of Single Pharmaceutical Granules
Séverine Mortier, Ghent University, Belgium

  Invited Lectures
13.45-14.20 Making continuous processing a reality: Tales from an early adopter
Dr. Marcel de Matas, AstraZeneca, Macclesfield, United Kingdom
14.20-14.55 PAT based advanced control of continuous manufacturing of solid dosage form
Dr. Steve Hammond, Pfizer, New Jersey, USA
  Oral Presentations
14.55-15.15 Ultrasound and NIR Monitoring of a Pharmaceutical Hot-Melt Extrusion Process
Lien Saerens, Ghent University, Belgium
15.15-15.50 Break & Posters
15.50-16.10 Continuous Technology of Nanopharmaceuticals Controlled with Micro-Raman Spectrometry
Gyorgy Marosi, Budapest University of Technology and Economics, Hungary
16.10-16.30 Continuous Pharmaceutical Manufacturing with Hot Melt Extrusion
Daniel Markl, Research Center Pharmaceutical Engineering GmbH, Austria
16.30-18.00 Industrial Session


Industrial session
Conference day 1 will end with a discussion session on ‘Bridging the Gap between Industry and Academia for Stimulating QbD and PAT Underpinning Scientific Research’. The session will start with two 15 minute presentations, one given by an industrial QbD and PAT scientist (Dr. A. Gerich, MSD, The Netherlands) and one given by an academic QbD and PAT scientist (Prof. J. Rantanen, University of Copenhagen, Denmark), in which both speakers will give their vision on the session topic. Both presentations will form a starting point for interactive discussion with the audience, which will be chaired by Prof. S. Folestad (Chalmers University and Astra Zeneca, Göteborg and Mölndal, Sweden) and Dr. Philippe Cappuyns (J&J and ISPE Belgium, Beerse, Belgium).

Thursday, May10, 2012 (8.30 – 16.45)
8.30-8.45 Opening
  Invited Lectures
8.45-9.20 How to Optimize Biopharmaceutical Production Processes in a Small Pilot Scale Approach
Prof. Dr. Reiner Luttmann, Hamburg University of Applied Sciences, Germany
9.20-9.55 PAT Tools for Fermentation Processes
Prof. Dr. Krist Gernaey, Technical University of Denmark, Denmark
  Oral Presentations
9.55-10.15 Is Ultrasonic Resonator Technology an Alternative to Raman spectroscopy for Drug Quantification in Complex Lipid-Based Formulations?
Cordura Stillhart, University of Applied Sciences Northwestern Switzerland, Switzerland
10.15-10.35 Near-Infrared Spectroscopy for In-line Monitoring of Protein Unfolding and its Interactions with Lyoprotectants during Freeze-Drying
Sigrid Pieters, Free University of Brussels, Belgium
10.35-11.05 Break & Posters
11.05-11.25 Freeze Drying Formulation and Process Design using Raman Spectrometer Equipped Micro Scale Freeze Drying Stage
Ari Kauppinen, University of Eastern Finland, Finland
11.25-11.45 PAT and Smart Chemometrics in Rapid Prototyping and Scale-up
Ornella Preisner, Newcastle University, UK
11.45-12.05 Freeze-Drying in Well-Plates as Formulation Development Tool
Holger Grohganz, University of Copenhagen, Denmark
12.05-13.00 Lunch & Posters
13.00-13.45 Interactive Poster Presentations
 

Parallel Session I

1. Main and Interactions of Individual Principal Components Regression (MIPCR) as a Robust Method in Modelling of Moisture Content in Freeze-Dried Mannitol Containing Products
Wai Lam Yip, University of Oslo, Norway

2. Diffusing Wave Spectroscopy for Contact-Free Rheological Analysis of Self-Emulsifying Drug Delivery Systems
Andreas Niederquell, University of Applied Sciences Northwestern Switzerland, Switzerland

3. Physical Stability of the Calcium Salt of Atorvastatin in the Presence of Acidic Excipients
Niels Peter Aae Christensen, University of Copenhagen, Denmark

4. Evaluation of Lyophilized Viral Vaccine Formulations Using NIR Spectroscopy
Laurent Hansen, Ghent University, Belgium

5. On-line Ultrasound Microstructure Characterisation of Pharmaceutical Materials
Richard J. Tweedie, Industrial Tomography Systems plc, United Kingdom

 

Parallel session II

1. Definition of a Successful Control Strategy for API-CQAs by Using the Quality by Design Principle
Zadeo Cimarosti, Aptuit, Italy

2. Eyecon™ Particle Imager in Granule Size Measurements: A case study with Cellets®
Tuomas Ervasti, University of Eastern Finland, Finland

3. Optimisation of Alfuzosin Tablet Formulations by Using Genetic Algorithm Program
B. Mesut, Istanbul University, Turkey

4. Real-Time Raman Spectroscopy for Crystallization Processes
Hajnalka Pataki, Budapest University of Technology and Economics, Hungary

5. Comparative Study to Evaluate the Performance of DMA vs. DSC and the Rheometer to Study the Thermal-Mechanical and Rheological Properties of Polymer Coating Film
Abrahem M. Abrahem, University of Bradford, United Kingdom

  Invited Lectures
13.45-14.20 Modeling Tools for Process Understanding of Biopharmaceutical Problems
Prof. Dr. Anna de Juan Capdevila, University of Barcelona, Spain
14.20-14.55 PAT Based Control for a Biopharmaceutical Production Process
Dr. Paul Jeffers, Pfizer, Ireland
  Oral Presentations
14.55-15.15 Improvements in Moisture Monitoring by a Novel Dual Frequency Microwave Resonance Technology Sensor
Benjamin Kollar, Heinrich-Heine-Universität, Germany
15.15-15.50 Break & Posters
15.50-16.10 Development of a Fluid Bed Granulation Control Strategy using Real-Time Process and Product Measurements
Anneleen Burggraeve, Ghent University, Belgium
16.10-16.30 Novel Microwave Technology Platform for Process Tomography in Monitoring and Control of Pharmaceutical Processes
Livia Cerullo, Chalmers University of Technology, Sweden
16.30-16.45 Closing Remarks

Pre-conference Workshop on Continuous Processing for Tablet Manufacturing
The pre-conference workshop will provide training on how to establish and optimize continuous processes from a scientific perspective. The morning session (at Ghent University) will theoretically approach the following topics:

• Overview and general introduction into continuous manufacturing of formulated products
• PAT based monitoring and control of continuous manufacturing processes
• How to establish and optimize continuous process trains from a scientific perspective

The afternoon session will be a hands-on training, organised at GEA Pharma Systems (Antwerp) - Collette™, in which the morning session topics will be considered from a practical point of view.

To register to the training day on ‘continuous pharmaceutical manufacturing of solid dosage forms’ (May 8, 2012, at the Faculty of Pharmaceutical Sciences from the University of Ghent), also use the on-line registration form. For more information on the pre-conference workshop, see the information on the University website: http://www.ugent.be/fw/en/research/pharmaceutical-analysis/pat/

Registration
On-line registration for EuPAT5, May 09-10, 2012, and for the training day on “continuous pharmaceutical manufacturing of solid dosage forms”, May 08, 2012, is available.

Please click here to access the on-line registration.

EuPAT 5
  Fee Excl. VAT 21% VAT added
Industry Early Member € 600 € 726
Early Standard € 650 € 787
Late Member € 700 € 847
Late Standard € 850 € 1029
Academic/Regulatory Early Member € 350 € 424
Early Standard € 400 € 484
Late Member € 450 € 545
Late Standard € 500 € 605
Student Early € 200 € 242
Late € 300 € 363

Pre-conference day
    Excl. VAT 21% VAT added
Industry Early Member € 250 € 303
Early Standard € 300 € 363
Late Member € 350 € 424
Late Standard € 400 € 484
Academic/Regulatory Early Member € 150 € 182
Early Standard € 200 € 242
Late Member € 250 € 303
Late Standard € 300 € 363
Student Early € 50 € 61
Late € 100 € 121

The Early bird registration fee is available until March 15, 2012. As of March 16, 2012 the Late registration fee will apply.

Payment
Payment can be made by Credit Card (American Express, Eurocard/Mastercard, VISA) and/or Bank Transfer.
Bank Transfer will be available until April 17, 2012. After this date only Credit Card payments will be accepted.
Please note that personal cheques, company cheques, Eurocheques or Diners are not accepted for payment.

Cancellation Terms and Conditions
Notification of cancellation must be made in writing to Congrex. Cancellation of registration will be accepted until April 2, 2012 up until which date the total amount will be refunded less EUR 50 for administrative expenses. For cancellations made after April 2, 2012, we regret that no refunds can be made.
If you are unable to attend, your registration may be transferred to another member of your organisation for a cost of EUR 20. 

A hard copy of the Registration Form is available here.
The hard copy is a complement to the on-line registration form, must be completed and returned to Claudine-Rawoens@UGent.be

Accomodation
Accommodation at a special rate has been pre-reserved at the Hotel NH Gent Belfort. Please click here to print out the accommodation booking form. The completed form shall be sent directly to Hotel NH Gent Belfort, to the address details provided on the form. Please note that the accommodation should be booked, directly with the hotel, before March 1, 2012.

Hotel address details:
NH hotel Ghent Belfort, Hoogport 63, B-9000 Gent, Belgium. Tel +32 9 2683613; Fax +32 9 2336400.

Other accommodations also have special rates for conference participants. For reservation at one of these hotels, please contact the hotels directly and clearly mention the conference (EuPAT 5) and the conference organisation (Ghent University).

Please click here for Hotel List.

gent

On Ghent and the EuPAT 5 Venue
Ghent is a historic and very lively city in Belgium with a large cultural line-up, an active harbour and business life, innumerable sport facilities and an internationally renowned university (www.ugent.be/en/). Ghent is stimulating and idiosyncratic, but above all authentic. Unique culture and services of excellent quality make the city an appealing place to live. Against the unique historic setting of Ghent, there is a vibrant city where easy accessibility is a key trump – no tailbacks and just 45 minutes from Brussels Airport. The NH Hotel Ghent Belfort attracts both business and leisure travellers, located right in the centre of Ghent, next to the historic city hall building. There are numerous cosy restaurants in the neighbourhood of the hotel (http://www.nh-hotels.com/nh/en/hotels/belgium/ghent/nh-gent-belfort.html).

Additional Information
For more information and registration contact:

EUFEPS Meetings and Events
Veddesta Business Center SE-175 72 Jarfalla, Sweden
Email conferences@eufeps.org
thttp://www.ugent.be/fw/en/research/pharmaceutical-analysis/pat

For questions on your on-line registration, payment and/or cancellation please contact eufeps@congrex.com or +46 8 4596600.

Important Dates

Abstract Submission Deadline February 15, 2012
Early-Bird Registration Deadline March 15, 2012

EUPAT 5 Program Committee
Jukka Rantanen, University of Copenhagen, Denmark (QbD and PAT Sciences Network Chair)
Wim Oostra, MSD, Oss, The Netherlands (QbD and PAT Sciences Network Vice-Chair)
Marcel de Matas, Astra Zeneca, Macclesfield, United Kingdom (QbD and PAT Sciences Network Secretary)
Buket Aksu, Santa Farma, Istanbul, Turkey
Joao Almeida Lopes, University of Porto, Portugal
Philippe Cappuyns, J&J and ISPE Belgium, Beerse, Belgium
Thomas De Beer, University of Ghent, Belgium
Staffan Folestad, Chalmers University and Astra Zeneca, Göteborg and Mölndal, Sweden
Jarkko Ketolainen, University of Eastern Finland, Kuopio, Finland
Hans H. Lindèn, EUFEPS Executive Director, Stockholm, Sweden
Guido Pareijn, Siemens AG and ISPE Belgium, Antwerp, Belgium
Kris Schoeters, GEA Pharma Systems, Wommelgem, Belgium
Tom Van Den Kerkhof, J&J, Beerse, Belgium
Marco Weimer, Sanofi-Aventis, Frankfurt, Germany

eufeps logotype

Founded in 1991, the mission of EUFEPS is to advance excellence in the pharmaceutical sciences and innovative drug research, and to represent the interests of scientists engaged in drug research and development, drug regulation and drug policymaking. Currently, EUFEPS links 24 Member Societies in 24 European countries. It has, in addition, around 600 individual members (http://www.eufeps.org).

ispe logo

Founded in 1980, ISPE has worldwide headquarters in Tampa, Florida; an Asia Pacific office in Singapore; a European office in Brussels, Belgium; and Affiliates and Chapters in numerous countries around the world (http://www.ispe.org).

Universitet Gent logo

Founded in 1817 as a Latin-speaking State University by William I, King of the Netherlands, Ghent University is a relatively young university. After its independence in 1830, the Belgian State was in charge of the administration of Ghent University; French was the new official academic language. In 1930 Ghent University became the first Dutch-speaking university in Belgium. The Decree of 1991 assigned great autonomy to the university.

Over the years eminent scientists such as Joseph Plateau (physicist, considered as a pioneer in the development of motion pictures), Leo Baekeland (inventor of Bakelite) and Corneel Heymans (Nobel Prize winner in Medicine) studied and worked at Ghent University.

With a view to cooperation in research and scientific service, numerous research groups, centres and institutes have been founded over the years. Several of them are renowned worldwide, in various scientific disciplines such as biotechnology, aquaculture, microelectronics, history,...

Today, after decades of uninterrupted growth, Ghent University is one of the leading institutions of higher education and research in the Low Countries. Ghent University is an open, committed and pluralistic university with a broad international perspective.
Located in Flanders, the Dutch-speaking part of Belgium and the cultural and economical heart of Europe, Ghent University is an active partner in national and international educational, scientific and industrial cooperation.

Because it plays a leading role in the academic and scientific world, Ghent University attaches great interest to a transparent organization structure, a dynamic human resources policy, an active environmental policy, its support to spin-offs and other new initiatives,...

On the EuPAT Series
The EuPAT Conference Series is a unique forum for scientists and engineers, encouraging and promoting progress in science behind QbD and PAT, and strengthening the interdisciplinary scientific discussion that bridges between the various fields underpinning QbD and PAT. The focus of it is on scientific progress underpinning Innovative Manufacturing Control and Quality by Design. New findings and results from scientific research and technology development are discussed in the four areas that constitute the cornerstones of sessions of the EuPAT Conferences; Process Informatics; Process Modelling and Understanding; Advanced Process Sensors; and PAT Based Control and Process Integration.

On the EUFEPS QbD and PAT Sciences Network
Powering Science Based Process Understanding and Quality-by-Design for Medicines, the Network is there to focus on Process Analytical Technology and underpinning sciences, 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. All scientists involved in QbD and PAT sciences are more than welcome to become a member of the EUFEPS QbD and PAT Sciences Network (www.eufeps.org– Network and Networking).

EuPAT 5 sponsors

GEA logo jnsen logo
indatech logo kaiser logotype
siemens logo thermo logotype
umetrics logo universitet gent logotype


The European Federation for Pharmaceutical Sciences – EUFEPS
SE-175 72 Järfälla (Stockholm) Sweden
Tel +46 8 50582040   Fax +46 8 4113217   Email secretariat@eufeps.org