| 8.30 | |
Registration & Coffee
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| 9.00 | |
Chairman's Opening RemarksAhmad Abdul-Fattah , Scientist, Formulation and Process Development, Roche Pharmaceuticals |
| 9.10 |  |
Risk management approach and PAT tools to optimise lyophilisation robustnessYves Mayeresse, Director of Manufacturing, GSK Biologicals View Bio
- Introduction to risk management approach
- The dependent and independent parameters in the lyophilisation process
- The ICHQ9 and FMEA applied to freeze-drying process analysis
- How PAT tools can help to mitigate risk and increase robustness
- Utility of the methodology in the frame of process development
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| 9.50 | |
Comparison of spray drying and freeze drying technologiesSune Andersen, Principal Scientist Drying Processes, Novo Nordisk A/s
- A critical analysis of the two techniques
- Methodology and application of each method
- Their relation to the industry as a whole
- Conclusions on the two methods, and their relative benefits
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| 10.30 | |
Morning Coffee
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| 11.00 | |
Freeze dried powder flow analysisEdmond Ekenlebie, PhD Research Student, Aston University
- Structural characterisation of freeze dried powder – XRay Micro CT and others
- Benefits of free flowing powders, economical, packing and monitoring
- Excipient use and cycle design
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| 11.40 | |
Raman spectroscopy: A potential tool for obtaining real-time product informationSigrid Pieters, PhD, Vrije Universiteit Brussel View Bio
- A powerful tool for obtaining chemical and physical product information
- Rapid discrimination between native and non-native proteins in freeze-dried formulations
- Link mathematical model with biochemical knowledge
- Transfer of the model to in-line use: how dealing with spectral interferences?
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| 12.20 | |
Networking Lunch
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| 13.20 | |
Aseptic processing of Freeze dried Medicinal or therapeutic productsJames Drinkwater, Chairman, Pharmaceutical and Healthcare Sciences Society View Bio
- Key considerations in Aseptic processing of Freeze dried Biological products
- Compatibility of biological decontamination agents with freeze dried biological products
- Solutions for biological decontamination of Freeze dryer Automated Load-Unload systems (ALUS/Isolator/RABS/Rooms)
- Developments in Freeze dryer bio-decontamination with Hydrogen peroxide vapour as an alternative to steam sterilization
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| 14.00 | |
Experiences with the application of TEMPRIS®: a wireless, battery free PAT tool during the transfer from development scale to production scale Andrea Weiland-Waibel, Owner, Explicat Pharma GmbH View Bio
- Experiences in applying MTM (Manometric Temperature Measurement) and Thermocouples in a Lyostar to develop a suitable lyo-cycle in the development scale to support formulation development
- Application of TEMPRIS® in the Lyostar to perform lyophilization cycle robustness testings in the development scale
- Stressing the product above the known critical temperature to understand the impact to be able to predict possible difficulties in the production scale
- Experiences during the first two runs
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| 14.40 | |
Optimisation of industrial freeze drying cycle - 2 real life examplesJean Rene Authelin, Global Head of Pharmaceutical Engineering, Sanofi-Aventis View Bio
- Two examples of “old” products
- How product physical characteristics (Tg’, eutectic melting, crystallization kinetics..), process mathematical modelling and the equipment intrinsic limitations are taken into account
- How this assists in designing a safe and economically efficient freeze drying cycle
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| 15.20 | |
Afternoon Tea
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| 15.40 | |
R&D, production, management personnel interested in knowing about the importance of crafting a comprehensive and accurate URSLarry Ulfik, President, Applewood Scientific View Bio
- Is basic document referred to by all interested participants in a lyo project of any size
- The ramifications of the URS
- It’s uses in determining if vendor has completed producing the lyo, defining capability and therefore a regulatory benchmark document, defining the fit and finish of the lyo, determining space allocation for lyo placement
- Determining operating environment available in facility
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| 16.20 | |
Lyophilization Process Design, Development and Scale-up Sajal Patel, Scientist II, MedImmune View Bio
- Guidelines for freeze-drying process design and development
- General process development and scale-up challenges
- PAT for freeze-drying
- Advances in freeze-drying process monitoring and control
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| 17.00 | |
Chairman’s Closing Remarks and Close of Day Two
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