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2020 Virus Forum

PDA Europe Virtual Conference - Virus Forum

Jun 22 - Jun 23, 2020
9:00 AM
-
5:00 PM
| Central Europe Standard Time
Online
  • Virtual
  • Conference
  • Online
  • Europe

Overview

Dear Colleagues,

We would like to warmly invite you to join us once again for PDA Europe Virus Forum! 
In response to the expansion of Covid-19, PDA Europe has decided to present the Forum as a virtual conference on 22-23 June 2020!

All participants will be given the opportunity to connect with the presenters speaking from different locations simply by using their web browsers.

You will have the chance to hear regulatory representatives from European regulatory agencies and the U.S. FDA, academics, and industry experts share their newest insights on a variety of topics around viral safety. Most current topics such updates on the novel Corona virus will be included alongside considerations on viral clearance and inactivation studies, virus detection and the specifics needed for continuous manufacture.
The revision of the Guideline ICH Q5A on viral safety evaluation of biotechnology products derived from cell lines of human and animal origin will also be addressed. Join the exchange on how technological developments in virus detection and virus reduction are taken into account.
Hear updates from the Advanced Virus Detection Technologies Interest Group and engage with speakers in live discussions provided for each conference module!

The conference will be accompanied by an interactive virtual exhibition & scientific poster session. 
Throughout the day, you will have the opportunity to explore new developments and learn about the latest technologies and trends from our exhibitors and sponsors. 

Do not miss the chance to meet key decision makers in our industry by taking advantage of this new PDA format and be at the forefront of innovation!

See you online!

Agenda

  • Day 1
  • Day 2
  • Monday, 22 June 2020

    Module I: Opening, Current Challenges with COVID-19 & Addressing Viral Clearance
    12:30 - 14:55 CEST

    Hear industry experts present newest insights on SARS-COV-2 infectability of standard cell lines as well as detectability by adventitious virus test panels. This session will also address operational risk mitigation aspects on current challenges with the novel Corona Virus.
    The detergent Triton X-100 widely implemented in the manufacture of biological medicinal products for virus inactivation has recently raised environmental concerns and its use will therefore be prohibited in the European Union. This session addresses proposed replacement agents for Triton X-100, their effectiveness, and considerations for designing an effective detergent treatment.
    Welcome & Introductions Falk Klar, PDA Europe
    Welcome from the Chair Johannes Blümel, Paul-Ehrlich-Institut

    Current Challenges with COVID-19

    Moderator: 
    Johannes Blümel, Paul-Ehrlich-Institut
    News from the Biotech Vireome and SARS-CoV-2 as a Recent Reminder Thomas Kreil, Takeda
    Operational Controls to Mitigate the SARS-CoV-2 Challenge to the Virus Control Framework in Industrial GMP Manufacturing Facilities Annes Stokes, GSK

    Addressing Viral Clearance

    Moderator: 
    Andy Bailey, ViruSure
    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?

    Michael Karbiener, Takeda

    Live Q & A, Discussion

     

    Break and Virtual Exhibition
    14:55 - 16:15 CEST

     

    Module II: Considerations on Continuous Manufacture
    16:15 - 17:30 CEST

    Considerations on Continuous Manufacture

    Moderator: 
    Sebastian Teitz, Asahi Kasei
    Continuous downstream processing has the potential to transform the manufacture of biotherapeutic products through improvements to efficiency, cost and quality. Significant effort has been made in both academic and industry settings to adapt batch unit operations to their continuous counterparts. This session explores basic considerations for the design and validation of unit operations integrated into continuous downstream purification processes, and data will be presented that illustrates the impacts of potential continuous process conditions on viral clearance.
    Regulatory Considerations for Viral Clearance Strategies in a Continuous Setting Scott Lute, U.S. FDA
    Novel Spiking Methods Developed for Anion Exchange Chromatography Operating in a Continuous Process Kathryn Martin-Remington, BioReliance
    Continuous Viral Inactivation: Utilizing Viral Particles to Define the Minimum Residence Time within a Plug Flow Reactor Matthew Brown, Boehringer Ingelheim

    Live Q & A, Discussion

     

    Virtual Networking Event
    17:30 - 18:30 CEST

    Meet your peers in our virtual Networking Lounges

    Details subject to change without notice

  • Tuesday, 23 June 2020

    Module III: Viral Clearance and Inactivation Studies
    9:00 - 11:05 CEST

    Progress within the viral clearance arena continues to gather pace. Medical devices have become a focus due to the incorporation of components of animal origin and the inactivation of virus on solid matrices present several challenges in particular in the generation of suitable data for regulatory review. In addition, the inactivation properties of Hepatitis E virus (HEV), the causative agent of hepatitis E, have been difficult to study due to inefficient cell culture systems to assess HEV infectivity in vitro. Two presentations on robust HEV cell culture systems are presented which further allow the study of viral-host interactions. Recommendations for nanofiltration under PDA TR 41 are fully described and finally a presentation by CSL Behring will present a number of studies looking at the capacity of different nanofilters to remove viruses with different physicochemical properties and sizes.

    Viral Clearance and Inactivation Studies

    Moderator: 
    Alison Armstrong, Merck KGaA
    Validating Virus Clearance for Medical Devices: Challenges and Regulatory Expectations when Validating Inactivation Steps on Solid Matrices

    Andy Bailey, ViruSure

    The Cell Culture-derived HEV and the Virus Clearance Study of Plasma Derived Products Kaoru Sakai, Japan Blood Products Organization
    Robust Hepatitis E Virus Infection in Human Hepatocytes Eike Steinmann, Ruhr University Bochum
    PDA Activities and Updates on Virus Filtration TR 41 Sebastian Teitz, Asahi Kasei
    Nanofiltration as a Robust Methodology Contributing to Viral Safety of Plasma-Derived Therapeutics: 20 Years' Experience of Plasma Protein Manufacturers Nathan Roth, CSL Behring

    Live Q & A, Discussion

     

    Break and Virtual Exhibition
    11:05-12:30 CEST

     

    Module IV: Advanced Virus Detection Technologies Interest Group Session and Virus Detection
    12:30 - 14:45 CEST

    Advanced Virus Detection Technologies Interest Group Session

    Moderators:
    Arifa S. Khan, U.S. FDA
    Jean-Pol CassartGSK

    The Advanced Virus Detection Technologies Interest Group (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 bioinformatics 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.

    Updates on the Activities of the AVDTIG and Short Data Presentations Arifa S. Khan, U.S. FDA
    Jean-Pol Cassart, GSK
    Live Q & A, Discussion

    Virus Detection

    Moderator: 
    Arifa S. Khan, U.S. FDA
    Next generation sequencing has capabilities for sensitive and broad virus detection, including known and novel adventitious viruses. There are ongoing international efforts by regulators, industry, and CROs toward standardization and validation of NGS as an alternative assay for replacing or supplementing the current adventitious virus testing of biologics. This would facilitate achieving the global objective of reducing animal use and could potentially contribute to accelerating product development by providing results in a shorter time compared with the conventional in vivo and in vitro assays, which can take at least around 30 days. This session will provide the current perspectives on using NGS for virus safety testing in vaccines and other biologics, data from a study evaluating NGS as a replacement assay for in vivo testing, and an effort toward implementation of NGS for adventitious virus detection for product development.
    Updates from the US FDA Arifa S. Khan, U.S. FDA
    Evaluation of RNA Next Generation Sequencing (transcriptomics analysis) to Replace in Vivo Tests for Assessing the Viral Safety of Cells Marc Eloit, Pathoquest 
    Horst Ruppach, Charles Rivers
    Efforts Towards Development of a Next-Generation Sequencing Method for Adventitious Virus Detection Maria Bednar, Biogen

    Live Q & A, Discussion

     

    Break and Virtual Exhibition
    14:45-15:30 CEST

     

    Module V: Closing: Viral Safety of Biological Products
    15:30 - 17:00 CEST

    Viral Safety of Biological Products

    Moderator: 
    Thomas Kreil, Takeda
    Since the inception of the ICH Q5A Guidance on the Viral Safety of Biotechnology Products Derived from Cell Lines of Human or Animal Origin in 1995, it has been the basis for the regulatory evaluation of a broad range of products. While designed to already cover "products derived from in vitro cell culture, such as interferons, monoclonal antibodies and recombinant DNA-derived products including recombinant subunit vaccines, and also includes products derived from hybridoma cells grown in vivo as ascites" , now cell- and gene-therapy products also fall within the scope of the guidance, products it has hardly been focused on during its development. With a revision now under way, the future status is expected to be quite impactful for the work of regulators and industry alike, and an update from the regulatory and industry perspective thus very welcome.
    ICH Q5A: Updates on Revision #2 Johannes Blümel, Paul-Ehrlich-Institut
    ICH Q5A Revisions – An Industry Perspective on CHO Cell Product Virus Safety Qi Chen, Genentech/Roche
    Industry Experience with Viral Contamination in the Manufacture of Biologic Products and its Implications for Emerging Products Paul Barone, Consortium on Adventitious Agent Contamination in Biomanufacturing

    Live Q & A, Discussion

    Conference Closing

    Johannes Blümel, Paul-Ehrlich-Institut

    Thank You Remarks and Farewell

    Falk Klar, PDA Europe

    Details subject to change without notice

Registration Fees

Register Now
Registration Type Two Day Access One Day Access*
Member, Non-Member, Young Professional, Poster-Presenter € 799 € 449
Govern./Health Authority/Academic € 649 € 349

* To book a one-day access, please contact [email protected].


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