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2021 Lyophil-1988x680

2021 PDA Pharmaceutical Lyophilization Conference

Sep 14 - Sep 15, 2021
Central Europe Standard Time | Online
  • Virtual
  • Conference
  • Online
  • Europe
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!

Overview

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

Agenda

  • Day 1
  • Day 2
  • 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:
    Raf De Dier, Janssen J&J
    Cristiana Campa, GSK Vaccines

    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:
    Sabine Hauck, Leukocare
    Sebastian Groёl,
    Ludwig-Maximilians-University, LMU

    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:
    Sabine Hauck, Leukocare
    Yves Mayeresse, GSK Vaccines

    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.

  • 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:
    Anthony Cannon, MSD
    Sascha Pfeiffer,
    Pharmbiocon

    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:
    Thomas Beutler, GEA
    Maik Guttzeit, Bayer

    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
    Michael De Felippis, Eli Lilly & Company
    Raf De Dier, Janssen J&J
    Anthony Cannon, MSD

    Thank You Remarks and Farewell Falk Klar, PDA Europe


    Agenda is subject to change without notice.

Highlighted Speakers

Serena Bobba
Serena Bobba
Merck Serono
Raf De Dier
Raf De Dier
Janssen J&J
Maite Harguindeguy
Maite Harguindeguy
Politecnico di Torino
Kristien Janssen
Kristien Janssen
Pfizer
Magdalena Puttnies
Magdalena Puttnies
LMU Munich
Ragini Shivji
Ragini Shivji
European Medicines Agency
Maximilian Thomik
Maximilian Thomik
Otto-von-Guericke University in Magdeburg
Mats Welin
Mats Welin
Swedish Medical Products Agency

Registration Fees

Register Now
Early Registration
Registration Type Price by 18 JULY 2021
Virtual Member €1.395
Virtual Non-Member €1.695
Virtual Govern./Health Authority/Academic
Young Professional (Member)
€600
 All fees given in Euro, excluding VAT

Regular Registration
Registration Type Price after 18 JULY 2021
Virtual Member €1.595
Virtual Non-Member €1.895
Virtual Govern./Health Authority/Academic
Young Professional (Member)
€600
All fees given in Euro, excluding VAT

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