Skip To The Main Content

Virus Forum

May 08 - May 09, 2018
Florence, Italy

Advanced Technologies for Virus Detection & Clearance in Biological Products

  • Conference
  • Europe

left to register

Program Highlights
The brochure is now available.
Call for Abstracts

Overview

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!

Sincerely,

Johannes Blümel, PhD, Paul Ehrlich Institut

Agenda

  • Tuesday, 8 May 2018

    9:00
    Welcome and Introduction
    Falk Klar, PDA Europe
    Johannes Blümel, Conference Chair, PEI

    9:10 - 9:40
    Keynote
    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

    9:40
    European Regulatory Developments
    Johannes Blümel, PEI

    10:00
    Advances in Viral Safety of Biotechnology Products: Office of Biotechnology Product's Perspectives
    Speaker, US FDA invited

    10:30
    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

    11:30
    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

    12:00
    Establishment of A Highly Efficient Hepatitis E Virus (HEV) Cell Culture System in Human Liver Cells
    Eike Steinmann, Twincore

    12:30
    Development of An Efficient Hepatitis E Virus Cell Culture Infectivity Assay for Evaluating the Clearance Capacity of Biological Manufacturing Processes
    Nathan Roth, CSL Behring

    13:00
    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

    14:30
    Viral Safety of Multi-Modal Chromatography
    Speaker, US FDA, invited

    15:00
    HTS Application in Virus Clearance by Chromatography, Two Case Studies
    Min Zhang, Genentech

    15:30
    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

    14:30
    Virus Filtration – An Update on Performance and Use in Continuous Processing Data
    Horst Ruppach, Charles River Labs

    15:00
    Virus Filtration in Continuous Bioprocessing
    Morven McAlister, PALL

    15:30
    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

    16:30
    Facilitating Efficient Chromatography-Free Virus Validations in Early Stage Purification Processes of Therapeutic Antibodies
    Moritz Bennecke, Roche Pharma

    17:00
    Retrovirus Clearance Risk Evaluation and Clearance Target for CHO Cells
    Bin Yang,, Genentech

    17:30
    Q&A, Discussion

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

    16:30
    Continuous Processing – The Challenges and Chances of Virus Retentive Filtration
    Birte Kleindienst, Sartorius Stedim

    17:00
    Challenges of Implementing Virus Filtration into Continuous Manufacturing
    Daniel Strauss, Asahi Kasei

    17:30
    Q&A, Discussion

    18:30
    Networking Dinner

    Wednesday, 9 May 2018

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

    8:00
    Virus Detection Interest Group Meeting

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

    09:00
    Next Generation Sequencing Efforts at CBER
    Speaker, US FDA invited

    09:30
    High -Throughput Sequencing as a Method to Qualify Virus Stocks
    Davide Scaglione, Merck KGaA

    10:00
    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

    11:00
    An Innovative Next Generation Sequencing Approach for the Specific Detection of Replicative Viruses in Cell Substrates
    Audrey Brussel, LFB

    11:30
    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

    13:00
    Inactivation of Enveloped Viruses with non-eco-toxic Detergents
    Shengjiang Shawn Liu, Bayer

    13:25
    Possibility of Effective Removal of Porcine Circo-Viruses from Manufacturing Process of Plasma and Bio-Products
    Mikihiro Yunoki, Japan Blood Products Organization

    13:50
    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

    14:45
    Viral Clearance Across Intensified Polishing and Virus Filtration Operations
    David Bohonak, EMD Millipore

    15:10
    Adsorptive Pre-Filtration: Impact on Virus Filtration Performance and Design of Virus Spiking Studies
    Peter Kosiol, Sartorius Stedim

    15:35
    Probing Virus Capture by Parvovirus Filters Using Confocal Microscopy and Scanning Electron Microscopy (SEM
    Dayue Chen, Eli Lilly

    16:00
    Q&A, Closing Panel Discussion

    16:30
    Summary & End of Conference

Additional Information

  • Call for Abstracts

    Download Call for Papers

    Call for Papers/Abstracts is available now.

    Download

    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

    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.

Got a Question? We have answers

Contact Us

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.

  • Accommodations
  • Amenities

How to Get Here

By Air

By Car

Other Options

Directions

Registration Fees

Early Registration
Regular Registration

* For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to receive this rate.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact registration@pda.org or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent by , no fee will be charged. After , a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent by , a full refund will be given minus a $200 fee. After , no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to registration@pda.org. Phone messages are not accepted.

Sponsors

Become a Sponsor

Interested in becoming a sponsor? Learn about opportunities and benefits.

Request Information

Featured Exhibitors

Attendee List Email Scam

Unfortunately, emails are circulating that offer to sell attendee lists for many of PDA’s conferences and events. These emails are sent by scammers.

Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Statements claiming to offer our attendee lists are fraudulent. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately.

Become an Exhibitor

Interested in becoming an exhibitor? Learn about opportunities and benefits.

Request Information

Media Partners

Contact

Program Inquiries
Exhibition Inquiries
Training Course Inquiries
Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
registration@pda.org

 

Stay Informed

Get the latest on registration, speakers, session details, exhibitor information, courses, and more by signing up to receive updates on .
Select choices
 

PDA Members Save Substantially