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2023 VirusConf-1988x680

2023 PDA Virus Conference

Jun 20 - Jun 21, 2023
Madrid, Spain

Virus Safety in the Era of ICH Q5A (R2)

  • Conference
  • Europe
Closed
Program Highlights

Check out an exciting program including talks not only from big pharma, vendors and representatives of the Paul-Ehrlich-Institut, Center for Drug Evaluation and the U.S. FDA.

Overview

Dear Colleagues,

A very warm welcome on behalf of the Scientific Program Planning Committee and PDA. We are pleased to invite you to join us for the 2023 PDA Virus Conference to take place as a face-to-face event on 20-21 June 2023 in Madrid, Spain. This conference will follow a workshop hosted by PDA on "Viral Safety for ATMPs" due to take place on 19 June 2023 at the same venue as the 2023 PDA Virus conference.

This global meeting is organized in close collaboration with an excellent Scientific Program Planning Committee which includes European and U.S. FDA regulators, global industry experts, supplier specialists, and dedicated PDA support.

The overall program is designed to provide an update on regulatory expectations from a truly global perspective with representatives from the EU, the US, and Asia presenting the scientific framework for virus safety of plasma-derived and biotechnology medicinal products, as well as particularly innovative advanced therapy medicinal products. Following on from the recent publication of the draft ICH Q5A (R2) document, one of the conference's main themes will be best practices and understanding of the recommendations in this draft document.

Similar to earlier events in this long-standing series, current and newly emerging viral threats, viral safety considerations around the selection of low-risk starting materials, virus detection, and identification methods and strategies, and the design and validation of virus inactivation and removal process will be key topics for discussion. In addition, intensified continuous manufacturing processes and their potential impact on facility design and viral safety will also be considered.

Following the great success of the face-to-face meeting in Brussels in 2022, the 2023 PDA Virus Conference will again provide attendees the opportunity to gather for interactive discussions and continue to invigorate social interactions. This meeting continues to act as a discussion forum that allows for the direct interaction between industry and regulators and will continue to support the wider industry and improve the current understanding and acceptance of new technologies, highlight new and emerging viral risks, and explain novel regulatory approaches.

Panel discussions and ample networking opportunities will complement an impressive scientific program and make it is a worthwhile and well-rounded experience for you.

We look forward to meeting you in Madrid!

Sincerely,

The Co-Chairs

Alison Armstrong, Merck KGaA
Andy Bailey, ViruSure

SCIENTIFIC PROGRAM PLANNING COMMITTEE:

  • Alison Armstrong, Merck KGaA
  • Andy Bailey, ViruSure
  • Johannes Blümel, Paul-Ehrlich-Institut
  • Qi Chen, Genentech/Roche
  • Tomoko Hongo-Hirasaki, Asahi Kasei
  • Arifa Khan, U.S. FDA
  • Thomas R. Kreil, Takeda
  • Sean O’Donnell, Eli Lilly and Company
  • Sebastian Teitz, Biopharma Excellence
  • Josh Eaton, PDA
  • Falk Klar, PDA Europe
  • Stefanie Nebelin, Senior Manager Programs & Events, PDA Europe
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Agenda

Download full Agenda
  • Day 1
  • Day 2
  • Posters

  • Tuesday, 20 June 2023

    9:00

    Welcome and Introduction
    Falk Klar, PDA
    Alison Armstrong, Merck KGaA
    Andy Bailey, ViruSure

    9:15 - 11:15 I Opening Session: International Regulatory Updates
    Moderator:     Alison Armstrong, Merck KGaA

    Our first plenary session will establish the conference topic with presentations from international regulatory speakers selected from the EU, the US, and Asia. The speakers will touch on key points from the draft revision of ICH Q5A and will provide the most up-to-date understanding of viral risk mitigation as presented in this guidance. This draft regulatory document provides an up-to-date view of viral safety with increased scope to include well-established biological products and also new modalities such as viral vector products. The ability to use novel molecular-based technologies to address virus detection and the impact of a more flexible approach including platform validation and continuous viral inactivation for viral clearance will be discussed.

    Update on Revision of Guideline ICH Q5A
    Johannes Blümel, Paul-Ehrlich-Institut

    Technical Requirements for Platform Validation of Virus Clearance in Clinical Trial Applications and Strategies for Virus Safety Re-Evaluation of Process Changes
    Wenbo Sai, Center for Drug Evaluation - remote presentation-

    Continuous Viral Inactivation or Lifecycle Management for Viral Safety: A Case Study
    Sarah Johnson, U.S. FDA

    Q&A, Discussion

    11:15 - 11:45 Coffee Break, Poster Session & Exhibition

    11:45 - 13:15 I Session 1: Viral Clearance
    Moderator:     Tomoko Hongo-Hirasaki, Asahi Kasei and Sebastian Teitz, Biopharma Excellence

    Within the basic concept of ICH Q5A which is commonly referred to as the “Virus Safety Tripod of Biopharmaceuticals”, the pillar of virus clearance typically contributes the largest proportion in risk reduction to the biopharmaceutical product. This session will explore new approaches toward the measurement and detection of virus particles in the context of virus clearance studies and dive into the implementation and validation of virus filters into continuous processes.

    Constant Flow Rate Viral Clearance Study of Planova™ BioEX Virus Removal Filter and Implementation into an End-to-End Continuous Process for mAb Purification
    Hironobu Shirataki, Asahi Kasei

    Utilizing Retrovirus-like Particles (RVLP) to Evaluate Viral Clearance for Multiple Modes of Separation
    David Cetlin, Cygnus Technologies

    Improvements of Integrated Cell Culture-RT-qPCR to Facilitate Rapid Detection of Non-Cytopathic Viruses
    Remo Leisi, CSL Behring

    Q&A, Discussion

    13:15 - 14:30 Lunch Break, Poster Session & Exhibition

    14:00 - 14:30 LIVE GUIDED POSTER WALK Engage with our Poster Presenters in our Exhibition Hall

    14:30 - 16:00 I Session 2: Round Table Discussions
    Moderator:     Johannes Blümel, Paul-Ehrlich-Institut,

    With the recently published draft revision of ICH Q5A, four main topics with a major impact on the viral safety strategy have been identified. The revision opens the possibility to use prior knowledge for validation of viral clearance. The scope of ICH Q5A will be extended towards new product types such as certain viral vectors and testing for residual helper viruses used at vector production. Last but not least, the revised draft guideline acknowledges the recent advances in using next-generation sequencing for virus detection and the possibility of revising the adventitious agents testing strategy. Participants are invited to join specific subgroups to discuss their questions in an open scientific environment. Outcomes will be presented by the moderators to all participants.

    Working Group 1
    Moderator:     Sebastian Teitz, Biopharma Excellence

    Viral Clearance

    Working Group 2
    Moderator:     Johannes Blümel, Paul-Ehrlich-Institut

    Testing for Residual Helper Viruses

    Working Group 3
    Moderator:     Alison Armstrong, Merck KGaA

    New Product Types /Gene Therapies and Vaccines

    Working Group 4
    Moderator:     Andy Bailey, ViruSure

    Adventitious Agent Testing

    Summary of Round Tables & Take-Home Message

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

    16:30 - 17:50 I Session 3: Virus Detection
    Moderator:     Andy Bailey, ViruSure

    The ICH Q5A document promotes the wider application of Next Generation Sequencing (NGS) and PCR-based technologies for the detection of potential virus contamination. This session will explore how NGS can be effectively implemented in any adventitious agent testing program and how this technology compares with more traditional, infectivity-based, approaches. Demonstrating that NGS has the sensitivity for a broad range of potential contaminants is key and the presentations will present case studies addressing these key aspects.

    A Head-to-Head Comparison of Next Generation Sequencing (NGS) with Conventional Assays for Adventitious Virus Detection
    Arifa Khan, U.S. FDA and Shawn Polson, Computational Biology, University of Delaware, Newark

    Applying Next Generation Sequencing Technologies for Virus Safety Testing in a "Revision 2" World
    Bradley Hasson and Afshin Sohrabi, Merck KGaA

    Q&A, Discussion

    17:50 End of Conference Day 1 and Networking Event

  • Wednesday, 21 June 2023

    9:00

    Welcome to Day 2
    Alison Armstrong, Merck KGaA
    Andy Bailey, ViruSure

    9:05 - 10:20 I Session 4: Next Generation Sequencing - Efforts in the Advanced Virus Detection Interest Group (AVDTIG)
    Moderator:     Alison Armstrong, Merck KGaA

    The AVDTIG is a multidisciplinary international effort with a focus on developing standards and conducting collaborative studies for performance evaluation and qualification of NGS technologies for adventitious virus detection in biologics. The session will provide background, ongoing activities, and achievements of the Interest Group, and the status of ongoing collaborative studies for evaluating virus detection using short-read and long-read NGS technologies. Details of two spiking studies, which are completed/near completed, will be presented. The session will close with audience Q&A and discussion.

    General Updates from the Interest Group, Subgroups, and Collaborative Studies
    Keisuke Yusa, Kobe University,
    Siemon Ng, Notch Therapeutics -remote presentation-

    Status of Spiking Studies #2A (Minute Virus of Mice in Cellular Background) and #4 (Evaluation of Long-Read Sequencing)
    Simone Olgiati, Merck

    Study #3: Cell Transcriptomics Study for Evaluating Adventitious Virus Detection in Cell Substrates
    Noemie Deneyer, GSK

    Study #2B: Five Model Virus Spiking Study to Evaluate Adventitious Virus Detection in a Viral Seed or Vector Preparation
    Christophe Lambert, GSK

    Q&A, Discussion

    10:20 - 10:50 Coffee Break, Poster Session & Exhibition

    10:50 - 12:10 I Session 5: Manufacturing-Related Aspects
    Moderator:     Sean O'Donnell, Eli Lilly and Company

    Biopharmaceutical manufacturers are continually looking for ways to rapidly detect and prevent adventitious virus contamination and remove endogenous viruses in the manufacturing processes. High-Temperature Short Time (HTST) is a common method that is employed by manufacturers to inactivate any potential contamination in cell culture media and feeds, but implementation can be costly and take a lot of development time. In this session, the use of upstream virus filters to remove viral contamination from media and feeds will be discussed. Also, the use of PCR to detect endogenous viral loads in unprocessed bulk harvests and Xenotropic murine leukemia virus (X-MuLV) removal during the Protein A column chromatography unit operation will be discussed.

    Nucleic Acid Based Assays for Upstream Mitigation and Bulk Harvest Testing
    Chakameh Azimpour, Amgen -remote presentation-

    Characterization of Upstream Viral Filters for Virus Retention of Media and Feeds
    Benjamin Walker, Eli Lilly and Company

    Q&A, Discussion

    12:10 - 13:10 Lunch Break, Poster Session & Exhibition

    13:10 - 16:00 I Closing Plenary: Current Strategies and Challenges in the Future
    Moderator:     Andy Bailey, ViruSure

    This session will start with an interactive question and answer poll of the conference participants using Mentimeter on various aspects of virus safety of relevance to the conference. The ICH Q5A presents several new aspects and challenges for meeting the regulatory requirements around virus safety. Much of what the industry has learned in more than 30 years of performing virus clearance studies is reflected in the ICH Q5A document and the first presentation of this session will explore how these changes will impact how we perform such studies going forward. The second presentation will address how the new guidance impacts the whole package of adventitious agent testing for a well-characterized Chinese Hamster Ovary (CHO)-derived product. At the end of the session, participants are invited to join in a panel discussion with distinguished virus safety experts from both industries as well as regulatory agencies for a lively discussion around the revised requirements for virus safety testing.

    Interactive Questionnaire Session

    Viral Clearance Where Do We Go?
    Horst Ruppach, Charles River

    13:55 - 14:25 Coffee Break, Poster Session & Exhibition

    14:25 - 14:30 Passport Raffle

    Virus Safety Strategies for Chinese Hamster Ovary (CHO) Cell-Derived Products Using ICH Q5A (R2) Guidance
    John Fisher, Genentech/Roche

    Closing Panel Discussion
    Join our Discussion with Experts from the Industry and Regulatory

    • Alison Armstrong, Merck KGaA
    • Johannes Blümel, Paul-Ehrlich-Institut
    • Sarah Johnson, U.S. FDA
    • Arifa Khan, U.S. FDA
    • John Fisher, Genentech/Roche
    • Horst Ruppach, Charles River

    Co-Chairs Conference Summary
    Alison Armstrong, Merck KGaA
    Andy Bailey, ViruSure

    Closing Remarks & Farewell
    Falk Klar, PDA

    16:00 End of Conference

    Agenda is subject to change without notice, Speakers are invited, pending confirmation

  • The following posters will be presented during the Guided Poster Walk on Day 1 at 14:00h and during each break in the Exhibit Hall

    ICH Q5A REVISION OPENS THE DOOR TO INNOVATIVE SOLUTIONS FOR VIRAL SAFETY ASSURANCE OF BIOLOGICS
    Manjula Aysola, Merck

    DEVELOPMENT OF BIODEGRADABLE, REACH-COMPLIANT ALTERNATIVES TO TRITON TM X-100 DETERGENT FOR VIRUS INACTIVATION IN BIOTHERAPEUTIC PRODUCTION APPLICATIONS
    Alice Antonello, Merck

    CURRENT APPROACHES AND CONSIDERATIONS FOR VIRAL CLEARANCE IN CELL AND GENE THERAPY (CGT)
    Anja Tessarz, BioPhorum

    REDUCING THE HAYSTACK TO FIND THE NEEDLE: IMPROVED HTS ASSAY SENSITIVITY BY HOST DEPLETION IN BIOLOGICAL SAMPLES
    Song Sun, Sanofi

    VIRUS SAFETY AGAINST EMERGING VIRUSES: HISTORY AND ADVANCES OF CHALLENGES IN VIRAL FILTRATION TECHNOLOGY
    Tomoko Hongo-Hirasaki, Asahi Kasei

    EFFICIENT VIRUS INACTIVATION FOR ACID-SENSITIVE PROTEINS USING AN ECOFRIENDLY AMINE N-OXIDE-BASED DETERGENT
    Natalie Hoerold, Rentschler Biopharma SE

    LOW-ENERGY-ELECTRON IRRADIATION
    Judith Harnau, KyooBe Tech

    APPLICATIONS OF NEXT GENERATION SEQUENCING FOR ADVENTITIOUS VIRUS DETECTION: IMPACT OF ICH Q5A REVISION
    Anna Woodward, Merck

    FILTRATION METHODS TO OVERCOME NEW CHALLENGES IN VIRAL SAFETY
    Lawrence Okorafor, Pall Cooperation

    CHARACTERIZING AND OPTIMIZING VIROSART MEDIA FOR UPSTREAM VIRUS-RETENTIVE FILTRATION OF MEDIA AND FEEDS
    Benjamin Walker, Eli Lilly and Company

Highlighted Speakers

Johannes Blümel
Johannes Blümel
Paul-Ehrlich-Institut
Noémie Deneyer
Noémie Deneyer
GSK
John Fisher
John Fisher
Genentech
Bradley Hasson
Bradley Hasson
MilliporeSigma
Sarah Johnson
Sarah Johnson
U.S. FDA
Arifa S. Khan
Arifa S. Khan
U.S. FDA
Remo Leisi
Remo Leisi
CSL Behring
Simone Olgiati
Simone Olgiati
Merck
View All

Additional Information

  • Who Should Attend
    Pharma Companies
    • Biopharmaceutical Companies
    • Start-ups/Emerging Companies
    Suppliers/Vendors
    • Raw Materials
    • Consumables
    • Equipment
    Governmental Health Authorities
    • National/Local Authorities
    • European Authorities
    • International Authorities
    Service Providers
    • CDMOs
    • Contract Test Laboratories
    • Logistic Companies
    Consultancy
    • Freelancer
    • Consulting Firms
    Academia
    • Universities
    • Academic Research Institutes

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Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Madrid Marriott Auditorium Hotel & Conference Center

Avenida de Aragon No 400
Madrid, Spain

Make a Reservation
  • Accommodations

    PDA recommends the reservation at the following hotel

    Madrid Marriott Auditorium Hotel & Conference Center
    Avenida de Aragon No 400
    28022 Madrid
    Spain

    PDA Europe has reserved a limited number of rooms by 17 May 2023.

    Book your room at the PDA Group Rate via the above-mentioned reservation button.

  • Amenities

    Madrid Marriott Auditorium Hotel & Conference Center, located between International Airport and city center, is the perfect place to hold any kind of event and conference with innovation and style.

How to Get Here

By Air

Airport Madrid-Barajas is just 7 minutes away from the conference venue. Shuttle schedule to airport from 4:00 am until 2:15 am, from Hotel main entrance to departures in each terminal. The hotel does not guarantee seats available. Please check shuttle schedule operating hours directly with the hotel at 91 400 4400, through social media channels, or by email to [email protected]

By Car

On-Site Parking opportunities are available.

Other Options

Train station Gran Via is around 20 minutes away from the Madrid Marriott Auditorium Hotel.

Directions

Registration Fees

Early Registration
Registration Type Price by 23 April
Member €1.845
Non-member €2.145
Govern./Health Authority/Academic €870
Early Career Professional (Member) €870


Regular Registration
Registration Type After 23 April
Member €2.045
Non-member €2.345
Govern./Health Authority/Academic €970
Early Career Professional (Member) €970


Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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