| Day 3: 8 July | ||||||
| Keynote speaker | 9.00 | 10.00 | Current trends and challenges in freeze drying of biologics | Gerhard Winter | Current trends and challenges in freeze drying of biologics | |
| 10.00 | 10.15 | coffee break and poster session | ||||
| Session 1 | 10.15 | 11.45 | Formulation, chemistry | |||
| Jorge Sassone | Theory and Practice on alleged Buffer pH shifting during freezing in Lyophilized protein formulations | |||||
| Tim McCoy | formulation | |||||
| Ted Randolph | formulation, proteins | |||||
| 11.45 | 12.00 | discussion | ||||
| 12.00 | 13.30 | Lunch | ||||
| Session 2 | 13.30 | 15.00 | Process development, cells and organisms | |||
| Stephanie Passot | FD of cells/organisms | |||||
| Rongjun Chen | freeze-drying of cells | |||||
| Jeffrey Blue | formulation and freeze drying of vaccine | |||||
| 15.00 | 15.15 | discussion | ||||
| 15.15 | 15.45 | Coffee break and poster session | ||||
| 15.45 | 17.15 | Process development, modeling | ||||
| Roberto Pisano | mathematical models for freeze-drying of granules | |||||
| Daryl Williams | Moisture and secondary drying – surface area in freeze dried materials | |||||
| Sharmila Devi | Mechanics of 3D cellular freeze dried structures | |||||
| 17.15 | 17.30 | discussion | ||||
| Day 4: 9 July | ||||||
| Keynote Speaker | 9.00 | 10.00 | Tudor Arvinte | Scientific, yet creative process development, a different view on drying | ||
| scientific, yet creative process development, a different view on drying | ||||||
| 10.00 | 10.15 | coffee break and poster session | ||||
| Session 3 | 10.15 | 11.45 | Innovation | |||
| Jos Corver | continuous freeze drying | |||||
| Sophie Declomesnil (Lyofal) | Manufacturing principles of freeze dried medical device | |||||
| Chris Cherry | simpler sterility solutions to containment freeze drying | |||||
| 11.45 | 12.00 | discussion | ||||
| 12.00 | 13.30 | Lunch | ||||
| Session 4 | 13.30 | 14.30 | Presentation by PhD students (20 min each) | |||
| open | Selection to be made after receipt abstracts | |||||
| open | Selection to be made after receipt abstracts | |||||
| open | Selection to be made after receipt abstracts | |||||
| 14.30 | 14.45 | discussion | ||||
| 14.45 | 17.00 | Visit to facility | ||||
| 17.00 | 18.00 | Annual ISL-FD session | Kevin Tebrinke | |||
| Day 5: 10 July | ||||||
| Session 5 | 8.00 | 10.00 | Developments in freeze drying equipment | |||
| Maik Gutzeit | ||||||
| someone from IMA | ||||||
| Open | ||||||
| Open | ||||||
| 10.00 | 10.15 | discussion | ||||
| 10.15 | 10.30 | Coffee break and poster session | ||||
| Session 6 | 10.30 | 12.30 | Regulatory, Quality by Design and PAT | |||
| Thomas de Beer | Dynamic design space approach for the validation of pharmaceutical freeze-drying | |||||
| Geoff Smith | Process Analytical Technology and the Question of Scale | |||||
| Manuel Ibarra | local regulatory | |||||
| EMA | Regulatory issues | |||||
| 12.30 | 12.45 | discussion | ||||
| 12.45 | 14.00 | Lunch | ||||
| 14.00 | 14.30 | Awards, closing remarks, etc. | Kevin Tebrinke | |||
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