2021 PDA Pharmaceutical Lyophilization Conference
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Program Highlights
The Final Agenda is out now!
See all the Speakers by clicking the tab above, read up on them and think of some good questions to ask during live Q&As!
Only a few weeks to go, stay tuned or sign up today to not miss out!
Dear Colleague,
We warmly invite you to join this year's edition of the PDA Pharmaceutical Lyophilization Conference!
Check out an exciting agenda presenting highlights coming from academic research as well as the latest in industry applications and manufacturing developments.
This event will be presented jointly on one virtual conference platform with the 2021 PDA BioManufacturing Conference, making it an overall three-track, two conferences event!
Join us online and don't miss this very special 2-for-1 offer!
We look forward to meeting you online in September!
Sincerely,
The Chairs
Raf De Dier, PhD
Janssen J&J
Anthony Cannon,
MSD
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More information coming soon.
ALL PRICES IN EURO (EUR), EXCLUDING VAT.
WAYS TO REGISTER: 1. Online Registration 2. [email protected]
PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.
If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.
Day 1
Tuesday, 14 September 2021
Conference Platform Opens: Enjoy our Virtual Exhibition & Poster Session
11:00 - 12:00 CEST
Joint Opening Plenary with the BioManufacturing Conference
12:00-14:45 CEST
|
Joint Opening Plenary with the BioManufacturing Conference |
Moderators: |
| Opening Keynote: Reinventing Pharma through Digital and Analytics – where are we today? | Alvaro Carpintero, McKinsey |
| EMA’s Perspective on the SARS-CoV-2 Pandemic: Regulatory Procedures, Quality Flexibilities, and Future Directions |
Ragini Shivji, EMA |
| The EMA Acceleration Toolkit | Mats Welin, Swedish Medicines Agency |
| The Annex 1 Revision and the Impact on Biomanufacturing Processes | Yves Mayeresse, GSK Vaccines, Jörg Lümkemann, F. Hoffmann-La Roche |
| Speed to Clinic and How Different Functions Interact to Make it Happen | Matthieu Stettler, LONZA |
|
Live Q & A, Panel Discussion |
Break, Virtual Exhibition & Poster Session
14:45-15:45 CEST
Module I: Lyophilized Drug Product: Handling and Stability Considerations
15:45-16:55 CEST
|
Lyophilized Drug Product: Handling and Stability Considerations |
Moderators: |
| Preventing Oxidation of a Lyophilized Monoclonal Antibody by Smart Polymer Packaging | Nicole Härdter, LMU |
| Suitability of Intended Use Testing Based on a Simulated Lyophilized Drug Product | Diego A Zurbriggen, WEST Pharmaceutical Services |
| Co-Lyophilization of Reteplase and Dornase Alfa with Arginine Hydrochloride and Tranexamic Acid | Magdalena Puttnies, LMU |
|
Live Q & A, Discussion |
Module II: Simulation & Modeling
16:55-18:30 CEST
|
Simulation & Modeling |
Moderators: |
| Studying the Effects of Process Parameters on the Primary Drying Phase of a Freeze-Drying Cycle Model for a Vaccine Vial: A Hybrid Modelling Approach | Md Meraj Khalid, Aligarh Muslim University |
| SNOWFALL: A Stochastic Shelf-Scale Modeling Framework for the Freezing Stage in Freeze-Drying | Leif-Thore Deck, Swiss Technical Academy ETH Zurich |
| Pore Scale Studies of Lyophilization Based on In-Situ Visualization and Pore Network Modeling | Maximilian Thomik, Otto-von-Guericke University |
|
Live Q & A, Discussion |
End of Conference Day 1
Interactive Vaccines Interest Group Meeting
18:30 - 20:00 CEST
Agenda is subject to change without notice.
Day 2
Wednesday, 15 September 2021
Interactive Poster Session: Engage in a live Q&A opportunity with our Poster Presenters in a separate video chat room!
10:00 – 11:30 CEST
Break, Virtual Exhibition & Poster Session
11:30 - 12:00 CEST
Module III: Process Control, Process Development, and Process Environment
12:00 - 13:45 CEST
|
Process Control, Process Development, and Process Environment |
Moderators: |
| Infrared Imaging: A Powerful Non-Invasive Tool for Freeze-Drying Monitoring and Optimization | Maite Harguindeguy, Politecnico di Torino |
| Quality Control and Process Optimization Using Near-Infrared Spectroscopy in Freeze-Drying of Pharmaceutical Products | Serena Bobba, Merck Serono |
| Driving Quality, Traceability, and Production Efficiency by Using “Unique Containers” in Lyophilization | R. Tod Urquhart, Eagas |
|
Live Q & A, Discussion |
Break, Virtual Exhibition & Poster Session
13:45 - 14:30 CEST
Module IV: Equipment and Manufacturing Trends
14:30 - 16:10 CEST
|
Equipment and Manufacturing Trends |
Moderators: |
| Lyophilizer in Aseptic Production Lines: Challenges and Opportunities | Kristien Janssen, Pfizer Manufacturing Belgium |
| Application of Interventions Risk Evaluation Model (IREM) for Aseptic Processing Involving Lyophilization | Subrata Chakraborty, GxPFONT Consulting |
| Real-Time Analysis of Freeze-Dried Products as an Answer to Today’s Challenges in Vaccine Production | Fabien Chauchard, Indatech |
|
Live Q & A, Discussion |
Break, Virtual Exhibition & Poster Session
16:10 - 16:40 CEST
Module V: Green Manufacturing / Novel Materials & Methods
16:40 - 18:30 CEST
| Green Manufacturing / Novel Materials & Methods |
Moderators: Thomas Frank, Refolution Thomas Beutler, GEA |
| Current Developments in Refrigeration Solutions for Lyophilization | Thomas Frank, Refolution Thomas Beutler, GEA |
| Solvent-Based Products: Taking Freeze-Drying and Recovery to the Next Level | Fabian Plaum, HOF Sonderanlagenbau |
| Flammable Refrigerants in Lyophilization | Georg Gruenwalder, Roche Diagnostics |
|
Live Q & A, Discussion |
|
| LIVE Conference Summaries by the Chairs of the BioManufacturing and the Pharmaceutical Lyophilization Conferences |
Cristiana Campa, GSK Vaccines |
| Thank You Remarks and Farewell | Falk Klar, PDA Europe |
Agenda is subject to change without notice.
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