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Conference Documentation: Lyophilisation Europe

Conference Documentation: Lyophilisation Europe

SMi is proud to announce the return of the 4th annual Lyophilisation-Europe conference 2016 in London!

Lyophilisation is used by the pharmaceutical industry for years. Recently, more than 30% of parenteral Food and Drug Administration (FDA) approvals were for lyophilised drugs, and estimates predict that soon more than half of all injectable drugs will require lyophilisation. While a lot of R&D efforts have been input in freeze drying process with actual advancements, the process incurs huge costs and is very complex.
Join us at SMi’s 4th annual Lyophilisation-Europe Conference taking place on the 4th-5th July 2016 in London.

This event will explore QbD and the regulatory affairs, lyophilisation related topics such as with high concentration protein formulation, new techniques of freeze dryers and many more!

A series of practical case studies, interactive roundtables and panel discussion facilitated by leading industry experts will provide executives with useful tools and best practices to:
Controlling the impact of process variables and managing risk
Ensure product quality
Implement a robust lyophilisation process
Optimise spray drying process and formulation development for complex dosage forms
Optimise freeze drying process
Challenges in spray drying process and formulation development for complex dosage forms
Integrating risk-based approaches into QbD principles


Day 1
8:30
Registration & Coffee
9:00
Chairman's Opening Remarks
Sune Andersen, Principal Scientist Drying Processes, Novo Nordisk A / S
9:10
Application of QbD principles to design lyophilisation process robustness studies in support tech transfer of a freeze-dried vaccine component
Daniela Stranges, Senior Scientist, GSK
9:50
Constructing a robust design space based on product and process limitations
Kevin Ward, Director of R&D , BioPharma Technology
10:30
Morning Coffee
11:00
Sponsor session: Process scale up of nanoparticles
11:40
Freeze-drying protein and vaccine formulations
Paul Matejtschuk, Principal Scientist, NIBSC
12:20
Networking Lunch
13:30
Through vial impedance spectroscopy : A process analytical technology (PAT) to develop a rational lyophilization cycle
Geoff Smith, Professor of Pharmaceutical Process Analytical Technology , De Montfort University
14:10
Optimisation of industrial freeze drying cycle - Two case studies
Mostafa Nakach, Head of Pharmaceutical Engineering Group, Sanofi-Aventis R&D
14:50
Afternoon Tea
15:20
Continuous freeze drying of (Bio-) pharmaceuticals
Jos Corver, Founder, RheaVita BV
16:00
Panel discussion: Designing formulations for lyophilized products
Jos Corver, Founder, RheaVita BV
16:40
Chairman’s Closing Remarks and Close of Day One
Day 2
8:30
Registration & Coffee
9:00
Chairman's Opening Remarks
Sune Andersen, Principal Scientist Drying Processes, Novo Nordisk A / S
9:10
Challenges in spray drying process and formulation development
Sune Andersen, Principal Scientist Drying Processes, Novo Nordisk A / S
9:50
ATEX regulation applied to a manufacturing workshop of high potent injectables
Franck Pavan, Outsourcing Business Manager, Pierre Fabre
10:30
Morning Coffee
11:00
Sponsor session: Establishing the correct safety margins to prevent temperature collapse
11:40
On the use of PAT tools and statistical analysis to determine optimal freeze drying cycle parameters for scale-up
Erwan Bourles, Freeze dryer scientist, GSK
12:20
Networking Lunch
13:30
Panel discussion: Challenges of optimising filling processes and maintaining freeze dryers
Erwan Bourles, Freeze dryer scientist, GSK
14:10
Freeze-Drying of highly concentrated biologics at specific formulation conditions
Patrick Garidel, Head of Pharmaceutical Basic Development, Boehringer Ingelheim
14:50
Afternoon Tea
15:20
Modern process of lyophilization
Andrea Weiland, Pharmacist, Ph.D.Managing Director, Explicat Pharma GmbH
16:00
Uncertainty and global sensitivity analysis (GSA) for the (dynamic) design space determination of a traditional and continuous freeze-drying process
Thomas De Beer, Professor and Head of PAT, University Of Ghent
16:40
Chairman’s Closing Remarks and Close of Day Two

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