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Conference Documentation: Lyophilisation -Europe

The global market for lyophilisation is projected to be worth $3.26bn in 2015, spurred by the strong growth of new drugs and efforts to increase clinical approval. Lyophilisation is an established method in the formulation of biological products, and an invaluable tool for prolonging shelf life and stability for biological drugs and vaccines.

As under met needs in drug transport and long term storage continues to prevail, robust lyophilisation methods outlined in PAT and QbD principles as well as alternative technologies will continue to experience strong demand.

This conference will focus on the scale- up efforts in the pharmaceutical industry with key topics in:

PAT
Quality by Design
Vaccines
Biological drugs
Spray drying

In addition, a panel discussion on both days will focus on sale up and engineering issues, highlight new areas of innovation and debate whether small scale results in the laboratory provide realistic results in commercial scale up.


Day 1
8:30
Registration & Coffee
9:00
Chairman's Opening remarks
Poul Bertelson, Principal Scientist , Takeda
9:10
Opening Address: Applying Quality by Design Principles (QbD) and risk assessment
Poul Bertelson, Principal Scientist , Takeda
9:50
The Basics of Freeze Drying
Patrick Garidel, Process Sciences Department, Head of Pharmaceutical Basic Development, Boehringer-Ingelheim
10:30
Morning Coffee
11:00
Keynote address: Implementation of QbD in lyophilisation
Yves Mayeresse, Director primary and secondary Expertise, GlaxoSmithKline
11:40
Considerations for scale up
Michael Dekner, Manager of Innovation, Baxter BioSciences
12:20
Networking Lunch
13:30
Round Table Discussion Session
Poul Bertelson, Principal Scientist , Takeda
14:10
Spray-drying process development and scale-up for complex dosage forms: an alternative to lyophilisation
Eunice Costa, Process Developement Engineer, Hovione Sociedade Quimica SA
14:50
Crystal nucleation: Theory and Modelling
Jamshed Anwar, Associate Dean for Research & Professor of Computational Chemistry, Lancaster University
15:30
Afternoon Tea
16:00
The mechanical properties of lyophilised cakes
Daryl Williams, Reader in Particle Science, Imperial College London
16:40
Panel discussion
Yves Mayeresse, Director primary and secondary Expertise, GlaxoSmithKline
16:40
Panel discussion
Eunice Costa, Process Developement Engineer, Hovione Sociedade Quimica SA
16:40
Panel discussion
Michael Dekner, Manager of Innovation, Baxter BioSciences
17:20
Chair's Closing Remarks and Close of Day One
Poul Bertelson, Principal Scientist , Takeda
Day 2
8:30
Registration & Coffee
9:00
Chairman's Opening Remarks
Poul Bertelson, Principal Scientist , Takeda
9:10
Opening Address: Scale up methodologies for spray drying processes
Sune Andersen, Principal Scientist Drying Processes, Novo Nordisk A / S
9:50
Morning round table session
Poul Bertelson, Principal Scientist , Takeda
10:30
Morning Coffee
11:00
The value of modelling in spray dried product development
Andrew Bayly, Chair in Chemical Engineering, Institute of Particle Science and Engineering, Leeds University
11:40
Engineering Spotlight: Engineering a continuous process to ensure end product quality
Bruce Williams , Chartered chemical and process engineer,, Williams Process
12:20
Networking Lunch
13:30
Enabling technologies in lyophilisation processes
Andrew Tait, Postgraduate Research Engineer, Newcastle University
14:10
KEYNOTE: Implimenting QbD tools to optimise product quality
Pierre Lebrun, Associate Statistician - Project Leader, Arlenda
14:50
PAT on Pharmaceutical Processes
Edith Norrant , Innovations Technology Sciences DirectorInnovations Technology Sciences Director, UCB Pharma
15:30
Afternoon Tea
16:00
Panel discussion
Andrew Tait, Postgraduate Research Engineer, Newcastle University
16:00
Panel discussion
Patrick Garidel, Head of Pharmaceutical Basic Development, Boehringer Ingelheim
16:00
Panel discussion
Bruce Williams , Chartered chemical and process engineer,, Williams Process
16:00
Panel discussion
Edith Norrant , Innovations Technology Sciences DirectorInnovations Technology Sciences Director, UCB Pharma
16:40
Chair’s Closing Remarks and Close of Day Two

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