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Parenteral Drug Association Connecting People, Science and Regulation ®

Virus & TSE Safety Forum

May 30 - Jun 01, 2017 |
Jun 01, 2017 |
Sheraton Dubrovnik Riviera Hotel | Dubrovnik, Croatia
  • Conference
  • Europe
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Speaker Biographies

The first PDA Europe Virus & TSE Safety Forum was established in 2001 and since then, it has been held annually, alternating between Europe and the U.S. These truly global meetings are organized under the leadership of PDA in close cooperation with European regulatory agencies and the U.S. FDA. The meetings 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. One recurring topic to be set for discussion in the upcoming edition will be virus contamination of raw materials, as well as emerging viral threats.

A further topic of this year’s edition will be appropriate risk mitigation strategies consisting of two elements: i.) Testing and processing of raw materials and ii.) Virus removal/inactivation capacity of the processes used for production of medicinal products. The last day of the conference will focus on TSE and how much vCJD or BSE currently pose a threat to the safety of medicinal products. This year´s Forum, held at Dubrovnik from 30 May till 1 June, provides a unique opportunity for interactive discussion and benchmarking to all professionals working in the field. 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. Join us in vibrant Dubrovnik, a World Heritage Site on the Adriatic Sea, rich in history and culture, for a lively debate and networking!

Scientific Planning Committee

Johannes Blümel, Paul-Ehrlich-Institut, Co-Chair
Thomas R. Kreil, Shire, Co-Chair
Dayue Chen, Eli Lilly
Qi Chen, Genentech
Houman Dehghani, Amgen
Albrecht Gröner, PathoGuard Consult
Arifa Khan,US FDA
Michael Ruffing, Boehringer-Ingelheim
Sol Ruiz, AEMPS
Dorothy Scott, US FDA
Martin Wisher, BioReliance
Georg Roessling, PDA Europe


Tuesday, 30 May 2017

9:00
Welcome and Introduction

Georg Roessling, PDA Europe
Johannes Blümel, Paul-Ehrlich-Institut, Co-Chair
Thomas R. Kreil, Shire, Co-Chair

Session 1: Regulatory Developments

Moderator: Houman Dehghani, Amgen

9:10
Update on European Regulations
Johannes Blümel, Paul-Ehrlich-Institut

9:40
Convalescent Plasma for Immune Globulins – Viral Safety Issues
Dorothy Scott, US FDA

10:10
Validation of Virus Reduction at Continuous Processing
Scott Lute, US FDA

10:40
Panel Discussion

11:00
Coffee Break, Poster Session & Exhibition


Session 2: Hepatitis E Virus

Moderator: Thomas R. Kreil, Shire

The circulation of hepatitis E virus (HEV) as food-borne pathogen has only recently been recognized in industrialized countries. Infections remain mostly asymptomatic, as evidenced by high seroprevalence rates but low numbers of clinical case reports. HEV has, however, also been transmitted by transfusion of labile blood products, and has occasionally been detected in plasma pools for fractionation. It has thus been considered necessary to verify the safety margins of plasma products with respect to HEV, as primarily afforded by virus reduction steps embedded into their manufacturing processes.

11:30
Non-enveloped Viruses with a Lipid Envelope: Presence in Plasma and ‘Model’ Virus Preparation for Virus Reduction Studies

Maria Farcet, Shire

12:00
Hepatitis E Virus Stability Determination in Food – Achievements and Challenges
Reimar Johne, Federal Institute for Risk Assessment

12:30
Development of a Relevant Model Virus System, Cutthroat Trout Virus, for Hepatitis E Virus Clearance Studies
Nathan Roth, CSL Behring

13:00
Q & A, Discussion

13:30
Lunch Break, Poster Session & Exhibition


Session 3: Viral Risk Mitigation Strategies

Moderator: Albrecht Gröner, PathoGuard

Virus contaminations of biotechnology products derived from carefully tested and selected cell banks may arise from virus contaminated raw materials as cell culture media and by cross contamination of products. Risk mitigation strategies such as appropriate segregation of product intermediates within and between batches and inactivation / removal of adventitious viruses in raw materials will be presented..

14:30
Industry Approaches to Facility Segregation for Viral Safety
Paul W. Barone, Massachusetts Institute of Technology, Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB)

15:00
New Quantitative, Risk-based Approach to Appropriate Viral Segregation Measures
Kavita Ramalingam Iyer, MSD

15:30
Retrospective Evaluation on the Necessity of End of Use Resin Viral Clearance Studies - A Multiple Company Collaboration
John Mattila, Regeneron Pharmaceuticals, BioPhorum Development Group Viral Clearance Working Team

16:00
Mitigation of Risk of Viral Contamination of Media using Upstream Barrier Methods
Kathryn Martin Remington, BioReliance

16:20
Coffee Break, Poster Session & Exhibition

17:00
Minute Virus of Mice - Non-susceptible CHO Cell Line
Kevin Kayser, Merck KGaA

17:20
Defend Your Bioreactor: Using Nanofiltration to Prevent Virus Contamination of Cell Culture Processes
Christina Carbrello, Merck

17:40
Virus Risk Mitigation in Cell Culture Media –New Solutions
Anika Manzke, Sartorius Stedim Biotech

18:00
Q & A, Discussion

18:30
End of Day 1

19:00
Networking Reception

Wednesday, 31 May 2017

MORNING SESSION

Interest Group Meeting: Methods for Virus Detection

Moderators: Arifa Khan, US FDA Jean-Pol Cassart, GSK

The Advanced Virus Detection Technologies Interest Group (AVDTIG) is comprised of experts representing industry, academia, government agencies and regulators who discuss the current thinking and planned efforts regarding application of new technologies for virus detection in biologicals. The group's current focus is on next generation sequencing. The session will include brief presentations on the IG history, ongoing activities, and achievements followed by audience participation for Q & A and discussions on additional topics on advanced virus detection technologies for consideration by the IG.

7:30 Update on IG Activities Panel Discussion, Q&A

8:45
Welcome Coffee

Session 4: Methods for Virus Detection

Moderator: Arifa Khan, US FDA

The "traditional" assays have generally been effective for demonstrating absence of adventitious viruses; however, they may not be sufficiently broad to detect viruses that are distant to known viruses or novel viruses. Virus detection by the routinely used cell culture and molecular methods, and the advanced next generation sequencing technologies will be presented.

9:00
Update on NGS Efforts for Virus Detection
Arifa Khan, US FDA

9:30
Performance of Transcriptomic Analysis by NGS for the Detection of Viral Infection in Cells
Marc Eloit, PathoQuest

10:00
Detection of Different MMV Strains by Cell Culture and PCR Assays, and MMV Permissiveness of Cell Lines used in Biotechnology: How much do we really know?
Thomas R. Kreil, Shire

10:30
Comparing Classical vs New Assays
Siemon Ng, Sanofi

11:00
Q & A, Discussion

11:30
Lunch Break, Poster Session & Exhibition


Session 5: Virus Filtration

Moderator: Martin Wisher, BioReliance

The use of virus filtration in the processing of biological products is considered a robust and well accepted component of a virus clearance strategy. This session will provide new data on a number of topics related to the use of this technology including virus retention mechanisms, effects on virus reduction factors of different model parvoviruses, effects of process fluid properties, processing parameters and depressurization/re-pressurization, development of a new nano-cellulose based membrane, and the application of QbD to virus removal by filtration.

13:00
Differential Retention of Animal Parvoviruses during Virus Filtration
Thomas Nowak, CSL Behring

13:20
Retention Mechanisms in Virus Filtration: Membrane Contribution by Size Exclusion and Interactions Between Membrane, Viruses and Solutes under Varied Buffer Conditions
Björn Hansmann, Sartorius Stedim Biotecht

13:40
Understanding Virus Filtration and Designing Viral Clearance Studies to Accurately Assess Parvovirus Removal Capability
Daniel Strauss, Asahi Kasei

14:00
Demonstration of Effective Control of Viral Filtration Unit Operation to Adequately Address the Safety Concern Raised by Health Authorities
Dayue Chen, Eli Lilly

14:30
Coffee Break, Poster Session & Exhibition

15:00
Multiple, Deliberate Interruptions of a Virus Removal Filtration Process – Impact on Virus Retention and Throughput
Konstantin Zöller, Novartis Pharma AG

15:20
Nano-cellulose-based Small-size Virus Retentive Filters
Albert Mihranyan, Uppsala University

15:40
Application of Quality by Design (QbD) Principles for Validation of Virus Removal by Filtration
Morven MacAlister, PALL

16:00
Q & A, Discussion

17:00
End of Day 2


Thursday, 1 June 2017

Session 6: Virus Clearance

Moderator: Qi Chen, Genentech

Triton X-100 is a widely used detergent for enveloped virus inactivation. Due to environmental concerns of Triton X-100 degradation product, its use in the EU might be restricted through REACh. In this session, the current status and potential impact of the REACh authorization for Triton X-10 on biologics manufacturing in EU, as well as virus inactivation data from eco-friendly detergents will be discussed. Another hot topic in biologics manufacturing is continuous processing. Application of low pH virus inactivation and virus filtration in continuous processing will be presented.

9:00
Advocacy Efforts in Response to Anticipated REACh Regulation on Triton X-100
Marie Murphy, Eli Lilly

9:30
An Alternative "Eco-Friendly" Detergent to Triton X-100
Lenore Norling, Genentech

10:00
Continuous Viral Clearance for the Production of mAbs
Laura Holtmann, INVITE

10:30
Q & A, Discussion

11:00
Coffee Break, Poster Session & Exhibition


Session 7: TSE Safety

Moderator: Dorothy Scott, US FDA

Existing and emerging TSEs still present potential risks to safety of biological products. This session provides an update on human and animal TSE surveillance, including information about atypical BSE. Measures that reduce TSE risk in manufacturing include safe sourcing of raw materials, and use of decontamination methods that are effective against TSE agents. Methods for inactivation of prions exist but are often harsh and not always suitable for laboratory or manufacturing environments. A new chemical method to inactivate prions, as measured by RT-QuIC will be presented and discussed.

11:30
Surveillance (human) Including Appendix Studies, and Confirmed MV Case
Robert Will, University of Edinburgh

12:00
Inactivation of Prions with Hypochlorous Acid (RT-QuIC)
Byron Caughey, NIH

12:30
The Current Risk of Atypical BSE
Torsten Seuberlich, University of Bern

13:00
Q & A, Closing Panel Discussion

13:30
End of Conference, Farewell Lunch

4 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).
  • No PDA membership obtainable upon booking training course, workshop or other related event.

Registration Fees

Are you entiteld to receive a discount? Need Help?

Member

By 2 April 2017
1,595 Euro

After 2 April 2017
1.795 Euro

Nonmember

By 2 April 2017
1.895 Euro

After 2 April 2017
2.095 Euro

Govern./Health Authority/Academic

By 2 April 2017
800 Euro

After 2 April 2017
900 Euro

All fees given in Euro and excluding VAT (25%)

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

Sheraton Dubrovnik Riviera Hotel main entrance

Sheraton Dubrovnik Riviera Hotel
Šetalište Dr. Franje Tudmana 17 Srebreno
Mlini, 20207
Dubrovnik, Croatia
Tel: +385 20 601 500
Hotel Website

Newly built in summer 2015, this sleek and modern hotel has a refined style with clean, contemporary lines. Sink into the freshwater pool to take in the view of towering mountains that rise beyond Srebreno village. You can even follow the pine-lined promenade to the quaint village of Mlini and, from there, take a water taxi to Cavtat or Dubrovnik. Unwind in the Piano Bar or enjoy local delicacies at the Restaurant Leut, offering a dazzling view of the Adriatic Sea. For more relaxation, there’s a state-of-the-art spa where you can enjoy muscle-soothing treatments such as fragranced massages.

PDA Europe has reserved a limited number of rooms until the 21st April 2017.
Book your room for the PDA Group Rate.

Single Room € 150.00 per night
Double Room € 165.00 per night
Including breakfast, Wi-Fi, taxes & services, excluding City Tax

For reservations please contact Ivana Muhoberac, Sales Executive
T:+385 (0)20 601-384
E: ivana.muhoberac@drh.com.hr

How to Get There

Dubrovnik Airport – DBV
Airport Phone:+385 20 773 100

Hotel Direction: approximately 13 km / 8 miles
Options for getting to and from the hotel:
By Taxi: Fee: € 18 - 25 
Travel Time: 15 minutes

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

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