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Parenteral Drug Association Connecting People, Science and Regulation ®

Pharmaceutical Freeze Drying Technology

Nov 27 - Nov 28, 2018 |
Nov 28, 2018 |
MELIÁ SEVILLA | Seville, Spain
  • Conference
  • Europe
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Speaker Biographies

Dear Colleague,

We would like to invite you to submit a paper or poster abstract for presentation at the PDA Europe Pharmaceutical Freeze Drying Technology, 27-28 November in Seville, Spain.

During the last ten years, freeze-drying of biopharmaceuticals has become a routine procedure, yet the freeze-drying process remains complex. This meeting provides updates of various technical and regulatory aspects regarding lyophilization.

Speakers from the pharmaceutical industry, manufacturers and regulatory agencies regularly share their knowledge and give insights into this process, deepening the understanding of the underlying physicochemical principles as well as explaining freeze-drying techniques and the efforts to implement them on a big scale. All attendees learn about current and novel concepts of freeze-drying and get to connect and exchange ideas with experts in the field.

The friendly yet professional atmosphere of PDA‘s meetings provides abundant room for questions and answers, networking and exchange.

Get in touch with highly qualified and diverse professionals at this must-attend conference on lyophilization in beautiful Seville in November!

Sincerely,
The Co-Chairs

Yves Mayeresse,
GSK Vaccines, Chair

Sascha Pfeiffer,
Lyo Engineering, Co-Chair

Download Call for Papers

Submit Abstract

Tuesday, 27 November 2018

9:00
Welcome: Opening & Introduction
Kerstin Wilken, PDA Europe
Yves Mayeresse, Chair, GSK
Sascha Pfeiffer, Chair, Lyo Engineering

OPENING PLENARY

09:15 - 12:45
Session 1: Advancements in Process and Product Development
Moderator: Yves Mayeresse, GSK

09:15
The European F-Gas Regulation and the Consequences for Pharmaceutical Freeze-Drying
Thomas Beutler, GEA

09:45
Freeze Dryer Refrigeration System
Alexander Tambovzev, OPTIMA

10:15
Tert-Butyl Alcohol as an Excipient in Freeze-Drying of a Monoclonal Antibody
Julian Gitter, LMU Munich

10:45 – 11:15
Coffee Break, Poster Session & Exhibition

11:15
Freeze-Drying of a New Class of Medicines: Live Biotherapeutics
Sophie Declomesnil, 4DPharma

11:45
Specific Excipients to Protect Simian Adenovirus Vector During the Freeze-Drying Process
Frederic Mathot, GSK Vaccines

12:15
Q&A, Discussion

12:45 – 13:45
Lunch Break, Poster Session & Exhibition

13:45 – 15:30
Session 2: Equipment Characterization
Moderator: Thomas Beutler, GEA

13:45
Opportunities of Using Mass Spectrometer Technology in Lyophilization
Johannes Meiwald, Pfeiffer Vacuum

14:15
Lyophilizer Characterization: Determination of Equipment Heat and Mass Transfer Properties to Support Scale-up and Technical Transfer of Lyophilized Biopharmaceuticals
Sean Cullen, Sanofi

14:45
Use of Water Sublimation Test for Freeze-Dryer Cycle Adjustment to Avoid Meltback of a Low Cake Weight Lyo Product
Eric Miguez, Universal Farma

15:15
Q&A, Discussion

15:30 – 16:00
Coffee Break, Poster Session & Exhibition

16:00 – 18:00
Session 3: Critical Quality Attribute Monitoring
Moderator: Julian Gitter, University of Munich

16:00
Fast NIR Sensor for Online Moisture Control
Axel Haefner, GEA

16:30
Statistical Confidence in the Process: Insights Gained using Non-Destructive Moisture Determination Methods
Derek Duncan, LIGHTHOUSE Instruments

17:00
Methods to Predict Fogging in Lyophilized Drug Products
Roman Mathaes, LONZA

17:30
Panel Discussion, Q&A

18:00
End of Conference Day 1

18:30
Networking Event

Wednesday, 28 November 2018

09:00 – 10:30
Session 4: QbD Considerations
Moderator: Raf De Dier, Janssen J&J

09:00
Lyophilization Validation - Thermal Mapping
Davide Postacchini, Kaye

09:20
Another View of Freeze Dryer Design Space
Alexander Tambovzev, Optima Pharma

09:40
Recent Experiences with Continued Process Verification of a Lyocycle - Product Temperature as Process Control
Andrea Weiland-Waibel, Explicat Pharma

10:30
Q&A, Discussion

10:30 – 11:00
Coffee Break, Poster Session & Exhibition

11:00 – 13:00
Session 5: New Technologies & Container Systems
Moderator: Jörg Lümkemann, Roche

11:00
Optimization of Freeze Drying Nanocapsules by Using Experimental Design
Ghania Hamdi-Degobert, University of Lyon

11:30
Novel Approach to Drug Delivery: Spray Freeze-Dried Particles
Alf Lamprecht, University of Bonn

12:00
Freeze Drying in Novel Container Platforms
Daniel Kullmann, Hoffmann-La Roche

12:30
Q&A, Discussion

13:00 – 14:00
Lunch Break, Poster Session & Exhibition

14:00 - 15:00
Session 6: Predictive Models in Freeze Drying
Moderator: Yves Mayeresse, GSK
Moderator: Sascha Pfeiffer, Lyo Engineering

14:00
Process Modelling in Combination with Experimental Model Parameter Determination
Leon Klepzig, Technical University Clausthal

14:30
Process Parameter Determination by Through Vial Impedance Spectroscopy: A Prediction of Ice Interface Temperatures and Single-vial Heat Transfer Coefficients
Geoff Smith, De Montfort University

15:00 – 15:30
Coffee Break, Poster Session & Exhibition

15:30
Collapsed Lyophilized Drug Product - A Case Study
Daniel Molnar, Boehringer Ingelheim

16:00
Closing Panel Discussion, Q&A

  • Revision of Annex 1
  • Frequency of Steam Sterilization for FDs
  • Media Simulation Duration
  • Any other pressing issues

16:30
End of Conference and Farewell
Kerstin Wilken, PDA Europe
Yves Mayeresse, Chair, GSK
Sascha Pfeiffer, Chair, Lyo Engineering

3 Ways to register

Please remember to log in if you are a member of PDA already!

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

  • All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
  • All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)
  • Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).

Registration Fees

Are you entiteld to receive a discount? Need Help?

Member

By 14 October 2018
1.395 Euro

After 14 October 2018
1.595 Euro

Nonmember

By 14 October 2018
1.695 Euro

After 14 October 2018
1.895 Euro

Govern./Health Authority/Academic

By 14 October 2018
700 Euro

After 14 October 2018
800 Euro

All fees given in Euro and excluding VAT (21%)

Contact

Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0) 30 43 655 08-10
Fax: +49 (0) 30 43 655 08-66
Email

Exterior

MELIÁ SEVILLA
Calle Dr. Pedro de Castro 1
41004 Sevilla
Spain
Tel: +34 912 76 47 47
Hotel Website

Located in the heart of Seville opposite the Parque de Maria Luisa and Plaza España and very close to the University (Old Tobacco Factory), the Alcazar, the Barrio de Santa Cruz district, the Cathedral and the Archive of the Indies, the new Meliá Sevilla is the perfect choice for your business and leisure trips, thanks to its excellent location in the city centre, its fully equipped and comfortable facilities and the quality of its services.

Completely refurbished, the hotel offers a stunning outdoor pool with views of Plaza España and a spectacular Congress and Convention Centre. All the rooms at the new Meliá Sevilla are outward facing, comfortable and bright.

The hotel’s Mosaico restaurant serves an international breakfast buffet. There is also a poolside snack bar and a chic cocktail lounge, Elyxr.

PDA Europe has reserved a limited number of rooms until the 26th September 2018

Book Your Room for the PDA Group Rate

Single Room € 95 per night; 10% VAT, additional taxes and service charges will apply *
Double Room € 106 per night; 10% VAT, additional taxes and service charges will apply*

*Rates are per room and night, including the following services and benefits free of charge:

  • Buffet Breakfast in the restaurant
  • Wireless Internet Connection (WI-FI)

How to Get There

Seville Airport– SVQ
Airport Phone: +34 954 44 90 00
Hotel Direction: 11.8 km
The airport shuttle service is upon request for €25 per vehicle one way.

Parking

Parking available upon request at the registration desk.

Photos

Sponsorship and Exhibit Opportunities are Available!

For more information about exhibit and sponsorship opportunities, please contact:

Nadjeschda Gomez-Stahl
Manager Exhibition & Sponsorship
Tel: +49 (0) 30 43 655 08-23
Fax: +49 (0) 30 43 655 08-66
Email

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=4467

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