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Virus Forum

May 08 - May 09, 2018
Florence, Italy

Advanced Technologies for Virus Detection & Clearance in Biological Products

  • Conference
  • Europe

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Program Highlights
The brochure is now available.
Call for Abstracts


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!


Johannes Blümel, PhD, Paul Ehrlich Institut


  • Tuesday, 8 May 2018

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

    9:10 - 9:40
    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

    European Regulatory Developments
    Johannes Blümel, PEI

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

    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

    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

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

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

    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

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

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

    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

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

    Virus Filtration in Continuous Bioprocessing
    Morven McAlister, PALL

    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

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

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

    Q&A, Discussion

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

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

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

    Q&A, Discussion

    Networking Dinner

    Wednesday, 9 May 2018

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

    Virus Detection Interest Group Meeting

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

    Next Generation Sequencing Efforts at CBER
    Speaker, US FDA invited

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

    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

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

    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

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

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

    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

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

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

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

    Q&A, Closing Panel Discussion

    Summary & End of Conference

Additional Information

  • Call for Abstracts

    Download Call for Papers

    Call for Papers/Abstracts is available now.


    Abstract Submission

    Call for Papers/Abstracts is available now.

    Submit Abstract
  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • Accreditation


    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    Type of Activity:

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.

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