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pda.org/EU/Virus2020
22-23 JUNE 2020 BRUSSELS, BELGIUM
EXHIBITION: 22-23 JUNE
REGISTER BEFORE 19 APRIL AND SAVE UP TO €200!
2020 PDA EUROPE
Virus Forum
Dear Colleagues,
We would like to warmly invite you to join us once again for the PDA Virus Forum, this year to be held in Brussels, Belgium on 22-23 June 2020.
This truly global meeting is 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 inves-tigations 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. Appropri-ate 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.
Guideline ICH Q5A on viral safety evaluation of biotechnology products derived from cell lines of human and animal origin has always been a key regulatory document successfully ensuring viral safety of biopharmaceuticals. After 20 years of successful implementation, this guideline is now under revision taking the technological developments in virus detection and virus reduction into account. You will have the opportunity to learn about the topics being discussed. This will also include the application of viral safety methods towards continuous manufacturing processes.
By introducing Next Generation Sequencing (NGS), we are ex-periencing a revolution in virology, leading to ongoing discovery
of new viruses and opening new horizons for research as well as for characterization and control of biopharma-ceutical production. The PDA Interest Group on Advanced Virus Detection Technologies (AVTIG) will meet and you will hear about the latest efforts in standardizing and applying these techniques for detection of viral contaminants in biotechnological production.
PDA Europe’s Virus Forum reliably provides attendees a unique opportunity for interactive discussion and bench-marking. 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 Brussels this Summer!
Johannes Blümel, PhD Paul-Ehrlich-Institut, Chair
WELCOME FROM THE CHAIR
SCIENTIFIC PROGRAM PLANNING COMMITTEE
Johannes Blümel, Paul-Ehrlich-Institut, Chair
Alison Armstrong, Merck KGaA
Andy Bailey, ViruSure
Qi Chen, Genentech/Roche
Houman Dehghani, Allogene Therapeutics
Arifa S. Khan, US FDA
Thomas R. Kreil, Takeda
Sean O’Donnell, Eli Lilly & Company
Sebastian Teitz, Asahi Kasei
Martin Wisher, BioReliance – Merck KGaA
Josh Eaton, PDA
Falk Klar, PDA Europe
Teresa Schubach, Manager Programs & Events, PDA Europe
Directly followed by PDA Europe Advanced Therapy Medicinal Products Conference at the same venue!
2 pda.org/EU/Virus2020
WELCOME TOBRUSSELS
S C H E D U L E A T A G L A N C E
22 June 9:00 – 17:45 Virus Forum Conference, Exhibition
22 June 18:30 – 21:30 Networking Reception
23 June 9:00 – 16:30 Virus Forum Conference, Exhibition
For latest information, please visit: pda.org/EU/Virus2020
3pda.org/EU/Virus2020
CONFERENCE AGENDA
2 März 2020
Monday, 22 June 20209:00 Welcome: Opening Remarks & Introductions Falk Klar, PDA Europe
Johannes Blümel, Paul Ehrlich Institut, Conference Chair
Opening Plenary: Regulatory Updates Moderator: Thomas R. Kreil, Takeda
ICH Q5A (R2) Updates and an Update on the Corona Virus Epidemic Johannes Blümel, Paul-Ehrlich-Institut
ICH Q5A Revisions – An Industry Perspective on CHO Cell Product Virus Safety
Qi Chen, Genentech/Roche
Q&A, Discussion
10:40 Coffee Break, Poster Session & Exhibition
Session 1: Considerations for Continuous Manufacture Moderator: Sebastian Teitz, Asahi Kasei
Regulatory Considerations for Viral Clearance Strategies in a Continuous Setting
US FDA
Continuous Viral Inactivation: Utilizing Viral Particles to Define the Minimum Residence Time within a Plug Flow Reactor
Boehringer Ingelheim
Novel Spiking Methods Developed for Anion Exchange Chromatography Operating in a Continuous Process
Millipore Sigma
Q&A, Panel Discussion
13:15 Lunch Break, Poster Session & Exhibition
Session 2: Viral Clearance Moderator: Alison Armstrong, Merck KGaA
Insights into Virus Inactivation by Polysorbate 80 (PS80) in the Absence of Solvent
Sean O‘Donnell, Eli Lilly & Company
Of Micelles and Matrices: What Makes a Good Detergent for Virus Inactivation?
Takeda
Q&A, Discussion
15:30 Coffee Break, Poster Session & Exhibition
Session 3: Viral Clearance (continued) Moderator: Qi Chen, Genentech
PDA Activities and Updates on the Technical Report 41 on Virus Filtration
PDA Task Force
Predicting Viral Clearance: DOE, HTS and AAV Case Studies Utilizing a Non-Infectious MVM Surrogate during Downstream Development
MockV Solutions
Nanofiltration as a Robust Methodology Contributing to Viral Safety of Plasma-Derived Therapeutics: 20 Years’ Experience of Plasma Protein Manufacturers
Plasma Protein Therapeutics Association
Q&A, Panel Discussion
17:45 End of Day 1 & Networking Reception
4 pda.org/EU/Virus2020
CONFERENCE AGENDA
Tuesday, 23 June 2020Advanced Virus Detection Interest Group Session- Open to all conference attendees -
Moderators: Arifa S. Khan, US FDA Jean-Pol Cassart, GSK
8:00 The AVDTIG is an international effort aimed at evaluation and standardization of next generation sequencing technologies as an alternative assay for adventitious virus detection in biologics. The group has focused on sample selection and processing, reference materials (model viruses and databases), optimization of bioinfor-matics pipelines, and follow-up strategy designs. The session will include brief presentations on the background, ongoing activities and achievements of the IG, as well as preliminary results from collaborative virus spiking studies, followed by discussion and questions from the audience.
Session 4: Virus Detection Moderator: Arifa S. Khan, US FDA
9:00 Updates from the US FDA Arifa S. Khan, US FDA
Evaluation of RNA Next Generation Sequencing (Transcriptomics Analysis) to Replace In Vivo Tests for Assessing the Viral Safety of Cells
Pathoquest Charles Rivers
Commercial Development of a Next-Generation Sequencing Method for Adventitious Virus Detection
Biogen
Q&A, Discussion
10:45 Coffee Break, Poster Session & Exhibition
Session 5: Hepatitis E Moderator: Johannes Blümel, Paul-Ehrlich-Institut
Robust Hepatitis E Virus Infection in Human Hepatocytes Ruhr University Bochum
HEV Reduction in Plasma-Derived Medicinal Products Manufacturing Processes
LFB
The Cell Culture-derived HEV and the Virus Clearance Study of Plasma Derived Products
Japan Blood Organization
Q&A, Discussion
12:45 Lunch Break, Poster Session & Exhibition
Session 6: Emerging Viruses and Contamination Control Moderator: Andy Bailey, ViruSure
News from the Biotech Vireome Thomas R. Kreil, Takeda
Risk-Based Viral Segregation Strategies for Modern Manufacturing Facilities
Genentech
14:35 Coffee Break, Poster Session & Exhibition
Validating Virus Clearance for Medical Devices: Challenges and Regulatory Expectations when Validating Inactivation Steps on Solid Matrices
Andy Bailey, ViruSure
Industry Experience with Viral Contamination in the Manufacture of Biologic Products and its Implications for Emerging Products
Consortium on Adventitious Agent Contamination in Biomanufacturing
Q&A, Discussion
Closing Summary by the Conference Chair Johannes Blümel, Paul-Ehrlich-Institut
16:30 Closing Remarks and End of Conference Falk Klar, PDA Europe
5pda.org/EU/Virus2020
INFORMATION
VENUETangla Hotel Brussels Avenue Emmanuel Mounier 5Woluwé St Lambert1200 Brussels, Belgiumtanglabrussels.com/en/Special RatesPDA Europe has reserved a limited number of bedrooms until the 29 April 2020. Book your group rate for PDA.Single Room € 160 per night* Double Room upon request*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), VAT. Taxes and Service Charge will apply. Housing at the selected hotel will be in high demand, so we strongly recommend making your reservations early.
CONTACT INFORMATIONConference InquiriesMelanie DeckerDirector Events & [email protected] Program InquiriesTeresa [email protected] Customer CareTel: + 49 30 436 55 [email protected] Program InquiriesElke von [email protected]/Sponsorship Inquiries Christopher Hä[email protected]
GENERAL ADDRESSPDA Europe gGmbHAm Borsigturm 6013507 Berlin, GermanyTel: + 49 30 436 55 08-0Fax: + 49 30 436 55 08-66
CONFERENCE REGISTRATION HOURSMonday, 22 June: 8:00 – 17:30Tuesday, 23 June: 8:00 – 16:30
TO EXHIBIT:Exhibition and Sponsorship Opportunities are available. PDA meetings and conferences are a great opportunity for your company to gain on-site exposure in front of highly- qualified, upper-level professionals in the pharmaceutical and biopharmaceutical industry. Exhibit at PDA events and let your company’s products or services become a valuable tool or resource for our attendees.
SPECIAL REQUIREMENTSIf you require special accommodations to fully participate, please attach a written description of your needs with your registration form. Specific
questions can be directed to [email protected].
DIRECTIONS
© Google For directions click on the picture, scan the QR-code or go to www.tanglabrussels.com/en/
Special offer: Discounted travel with Lufthansa Group Airlines
Lufthansa Group Partner Airlines offer a comprehensive global route network linking major cities around the world. We offer spe-cial prices and conditions to participants, visitors, exhibitors, in-vited guests as well as employees of the Contracting partner and their travel companions. To make a reservation, please click on www.lh.com/event-flight-booking and enter the access code DEZLMTO in the "Access to Your Special Lufthansa Offer" area. This will open an online booking platform that will automatically calcu-late the discount offered or provide you with an even better offer if another promotional fare is available.
NOTE: Pop-ups must be enabled otherwise the booking platform window will not open.
These promotional fares are also available through your IATA / ARC travel agent. Travel agents can obtain ticketing instructions by sending an email to [email protected] and providing the access code as a reference.
6 pda.org/EU/Virus2020
REGISTER BEFORE 19 APRIL 2020 AND SAVE UP TO €200!
2020 PDA EUROPE
Cell and Gene Therapy - From Promise to Cure
Advanced TherapyMedicinal Products
24-25 JUNE 2020 BRUSSELS, BELGIUM
EXHIBITION: 24-25 JUNE
pda.org/EU/ATMPs2020
JOIN THE
INTERNATIONAL
COMMUNITY!
Live Simulcast Sessions
with PDA USA
Certified to
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Standards
ViruSure GmbH Tech Gate Science and Technology Park, Donau City Strasse 1, A-1220 Vienna, Austria
Telephone: +43-1-2699-120Telefax: +43-1-2699-12022E-Mail: [email protected]
Quality and Excellence in Pathogen Safety
Ensuring compliance with virus and prion safety requirements
ViruSure has extensive virological and regulatory expertise needed to meet your virus and prion safety testing challenges. With our GMP & GLP certified* state of the art testing laboratories and animal facilities (in vitro and in vivo) in Vienna, we can meet your requirements and guarantee a high level customer service.
- Virus clearance studies - Prion clearance studies • Western blot and bioassay titrations - In vitro and in vivo adventitious agent testing - In vivo Tumorigenicity/Oncogenicity - FPERT retrovirus testing - Cell banking and cell line characterisation - Biodistribution studies for gene therapy vectors - Genetic Stability Testing / Sequencing - GMP cell and virus bank storage - Consultancy services • Virus safety expert reports & Regulatory guidance
*ViruSure is inspected on a regular basis and holds a valid GMP & GLP certificate
Quality is not a coincidence!
ViruSure EBR Ad 2019.indd 1 13/02/2019 16:10:03
europe.pda.org
P DA E U R O P E E V E N T S2 0 2 0
21-22 April Visual Inspection Forum Berlin, Germany
9-10 June Quality and Regulations Conference Dublin, Ireland
22-23 June Virus Forum Brussels, Belgium
24-25 June Advanced Therapy Medicinal Products Brussels, Belgium
8-9 September Medical Devices and Connected Health Madrid, Spain
22-23 September BioManufacturing Dublin, Ireland
24-25 September Pharmaceutical Freeze Drying Technology Dublin, Ireland
20-21 October Aseptic Animal Health The Hague, The Netherlands
Subject to change For latest info: europe.pda.org Shortlist 4 Mar 2020
GENERAL INFORMATIONPDA EUROPE GGMBHAM BORSIGTURM 60
13507 BERLIN, GERMANYTEL: +49 30 4365508-0
FAX: +49 30 [email protected]
europe.pda.org
GENERAL INFORMATIONPDA EUROPE GGMBHAM BORSIGTURM 60
13507 BERLIN, GERMANYTEL: +49 30 4365508-0
FAX: +49 30 [email protected]
PDA EUROPE EDUCATION PROGR AM
2 0 2 0
23-24 April An Introduction to Visual Inspection TC Berlin, Germany
23-24 April Mastering Automated Visual Inspection TC Berlin, Germany
26-28 May Single-Use Systems – A New Age of Drug Making TC Göttingen, Germany
23 JunePractical Application of Risk-Based GMP and Quality Principles to Clinical Development of ATMPs
TC Brussels, Belgium
1-3 September Single-Use Systems – A New Age of Drug Making TC Göttingen, Germany
10-11 September Test Methods for Pre-fi lled Syringe Systems TC Madrid, Spain
24-25 September Environmental Monitoring and Contamination Control TC Dublin, Ireland
6-7 October Best Practices for Glass Primary Containers TC Mainz, Germany
9-13 November Freeze Drying in Practice TCOsterode am Harz, Germany
24-26 November Single-Use Systems – A New Age of Drug Making TC Göttingen, Germany
Subject to change For latest info: europe.pda.org Shortlist 4 Mar 2020
europe.pda.org
P DA E U R O P E E V E N T S2 0 2 0
21-22 April Visual Inspection Forum Berlin, Germany
9-10 June Quality and Regulations Conference Dublin, Ireland
22-23 June Virus Forum Brussels, Belgium
24-25 June Advanced Therapy Medicinal Products Brussels, Belgium
8-9 September Medical Devices and Connected Health Madrid, Spain
22-23 September BioManufacturing Dublin, Ireland
24-25 September Pharmaceutical Freeze Drying Technology Dublin, Ireland
20-21 October Aseptic Animal Health The Hague, The Netherlands
Subject to change For latest info: europe.pda.org Shortlist 4 Mar 2020
GENERAL INFORMATIONPDA EUROPE GGMBHAM BORSIGTURM 60
13507 BERLIN, GERMANYTEL: +49 30 4365508-0
FAX: +49 30 [email protected]
