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Virus Forum

Advanced Technologies for Virus Detection & Clearance in Biological Products
May 08 - May 09, 2018 |
May 09, 2018 |
Hilton Florence Metropole | Florence, Italy
  • Conference
  • Europe
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Speaker Biographies

Dear Colleagues,

We would like to warmly invite you to join us once again for PDA Virus Forum, this year to be held on 8-9 May 2018 in Florence / Italy. These truly global meetings are organized under the leadership of PDA in close cooperation with European regulatory agencies and the U.S. FDA. They provide an overview and updates on regulatory expectations and scientific investigations related to virus and TSE safety of biotechnology, plasma-derived and cell-derived medicinal products.

As in previous years, virus contamination of raw materials as well as emerging viral threats will be discussed.

Appropriate risk mitigation strategies consisting of two elements: (1) Testing and processing of raw materials and (2) Virus removal/ inactivation capacity of the processes used for production of medicinal products will be taken into consideration.

This PDA Europe Virus Forum reliably provides attendees a unique opportunity for interactive discussion and benchmarking. Exchange of information between industry and regulators will improve the understanding and acceptance of new techniques, highlight new and emerging risks and explain new regulatory approaches.

Panel Discussions, luncheons, dinners and a networking event will hopefully complete this impressive program and make it into a worthwhile and well-rounded learning experience for you!

We warmly invite you to join us in Florence this Spring!

Sincerely,

Johannes Blümel, PhD, Paul Ehrlich Institut

Download Call for Papers

Submit Abstract

Tuesday, 8 May 2018

9:00
Welcome and Introduction
Falk Klar, PDA Europe
Johannes Blümel, Conference Chair, PEI

9:10 - 9:40
Keynote
Cell Therapy Procedures and Regenerative Medicine: Ensuring Virus Safety to Avoid Past Mistakes
Thierry Burnouf, Taipei Medical University

9:40 - 11:00
Session 1: Regulatory Perspectives
Moderator: Dayue Chen, Eli Lilly

9:40
European Regulatory Developments
Johannes Blümel, PEI

10:00
Advances in Viral Safety of Biotechnology Products: Office of Biotechnology Product's Perspectives
Speaker, US FDA invited

10:30
CBER Perspective
Speaker, US FDA invited

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

11:30 - 13:00
Session 2: Hepatitis E Virus
Moderator: Thomas R. Kreil, Shire

11:30
Optimization of A Hepatitis E Virus (HEV) Cell Culture System and Isolation of 3 Novel Strains Stably Replicating to High Virus Concentrations
Mathias Schemmerer, Institute of Clinical Microbiology and Hygiene

12:00
Establishment of A Highly Efficient Hepatitis E Virus (HEV) Cell Culture System in Human Liver Cells
Eike Steinmann, Twincore

12:30
Development of An Efficient Hepatitis E Virus Cell Culture Infectivity Assay for Evaluating the Clearance Capacity of Biological Manufacturing Processes
Nathan Roth, CSL Behring

13:00
Panel Discussion with International Representatives

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

14:30 – 16:30
Session 3A: Concepts for Validation of Viral Clearance
Moderator: Johannes Blümel, PEI

14:30
Viral Safety of Multi-Modal Chromatography
Speaker, US FDA, invited

15:00
HTS Application in Virus Clearance by Chromatography, Two Case Studies
Min Zhang, Genentech

15:30
Method for Production of High Titer CHO Retrovirus-Like Particle Stocks for Virus Clearance Studies
Lindsey Silva, Genentech

14:30 – 16:30
Session 3B: Continuous Processing
Moderator: Albrecht Groener, PathoGuard

14:30
Virus Filtration – An Update on Performance and Use in Continuous Processing Data
Horst Ruppach, Charles River Labs

15:00
Virus Filtration in Continuous Bioprocessing
Morven McAlister, PALL

15:30
Continuous Low pH Viral Inactivation for mAb Production Processes
Laura David, INVITE

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

16:30 – 18:00
Session 3A: Concepts for Validation of Viral Clearance
Moderator: Johannes Blümel, PEI

16:30
Facilitating Efficient Chromatography-Free Virus Validations in Early Stage Purification Processes of Therapeutic Antibodies
Moritz Bennecke, Roche Pharma

17:00
Retrovirus Clearance Risk Evaluation and Clearance Target for CHO Cells
Bin Yang,, Genentech

17:30
Q&A, Discussion

16:30 – 18:00
Session 3B: Continuous Processing
Moderator: Albrecht Groener, PathoGuard

16:30
Continuous Processing – The Challenges and Chances of Virus Retentive Filtration
Birte Kleindienst, Sartorius Stedim

17:00
Challenges of Implementing Virus Filtration into Continuous Manufacturing
Daniel Strauss, Asahi Kasei

17:30
Q&A, Discussion

18:30
Networking Dinner

Wednesday, 9 May 2018

8:00 - 9:00
Session 4: Morning Session

8:00
Virus Detection Interest Group Meeting

9:00 – 12:00
Session 5: Virus Detection

09:00
Next Generation Sequencing Efforts at CBER
Speaker, US FDA invited

09:30
High -Throughput Sequencing as a Method to Qualify Virus Stocks
Davide Scaglione, Merck KGaA

10:00
Accelerating Lot Release Testing – The Development and Validation of a Culture Independent, Adventitious Agent Assay for GMP Biosafety Testing
Afshin Sohrabi, BioReliance

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

11:00
An Innovative Next Generation Sequencing Approach for the Specific Detection of Replicative Viruses in Cell Substrates
Audrey Brussel, LFB

11:30
Q&A, Discussion

12:00 – 13:00
Lunch Break, Poster Session & Exhibition

13:00 – 16:30
Session 6: Virus Inactivation & Clearance
Moderator: Martin Wisher, BioReliance

13:00
Inactivation of Enveloped Viruses with non-eco-toxic Detergents
Shengjiang Shawn Liu, Bayer

13:25
Possibility of Effective Removal of Porcine Circo-Viruses from Manufacturing Process of Plasma and Bio-Products
Mikihiro Yunoki, Japan Blood Products Organization

13:50
Evaluation of Viral Filters as an Alternative Virus Barrier(Medium Filtration)
Sean O'Donnell, Eli Lilly

14:15 – 14:45
Coffee Break, Poster Session & Exhibition

14:45
Viral Clearance Across Intensified Polishing and Virus Filtration Operations
David Bohonak, EMD Millipore

15:10
Adsorptive Pre-Filtration: Impact on Virus Filtration Performance and Design of Virus Spiking Studies
Peter Kosiol, Sartorius Stedim

15:35
Probing Virus Capture by Parvovirus Filters Using Confocal Microscopy and Scanning Electron Microscopy (SEM
Dayue Chen, Eli Lilly

16:00
Q&A, Closing Panel Discussion

16:30
Summary & End of Conference

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 24 March 2018
1.395 Euro

After 24 March 2018
1.595 Euro

Nonmember

By 24 March 2018
1.695 Euro

After 24 March 2018
1.895 Euro

Govern./Health Authority/Academic

By 24 March 2018
700 Euro

After 24 March 2018
800 Euro

All fees given in Euro and excluding VAT (22%)

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

Hilton Florence Metropole
Via del Cavallaccio 36
Florence 50142
Italy
Tel: +39-055-78711
Fax: +39-055-78718020
Hotel Website

The Hilton Florence Metropole offers spacious rooms, a wellness area with 24-hour gym. Free on-site parking and free WiFi in public areas are both available. Free shuttle service from/to the city centre is available. The Metropole has air-conditioned rooms with wood floors, a marble bathroom, and an LCD TV. Some rooms include access to the panoramic 15th-floor Executive Lounge, where guests can make use of free WiFi.

Breakfast is buffet style, while the restaurant Luci della Città serves Florentine dishes and international cuisine. Snacks and drinks are served in the cocktail bar indoors or outdoors on the patio.

Just 3 km from the A1 motorway exit, this Hilton is a 10-minute drive from the San Donato Park and Florence Peretola Airport.

PDA Europe has reserved a limited number of rooms until the 23rd March 2018.

Book your room for the PDA Group Rate

Single Room € 165 per night*
Double Room € 180 per night*

*Rates are per room and night, including the following services and benefits free of charge:
  • Buffet Breakfast in the restaurant
  • VAT, Taxes and Service Charge will apply

How to Get There

Florence Airport – FLR
Airport Phone: +39 055 30615
Hotel direction: 3 km

Parking

  • Self parking: (Free outdoor parking)
  • Valet: Not Available

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=4048

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