Join us and your peers for the 2nd European Viral Safety Experts Forum.
November 14-15, 2017 at the Merck KGaA, Darmstadt, Germany office and M Lab™
The forum will bring together viral safety experts to exchange around viral safety strategies for biopharmaceuticals.
During this two-day forum, you will have the opportunity to share scientific knowledge, industry trends, and best practices towards the implementation of viral safety, looking for innovative solutions to today's evolving processing requirements.
We look forward to seeing you.
Agenda*
Tuesday, November 14
| 9:00 - 09:45 | Breakfast and registration |
| Process development and validation related topics | |
| 9:45 - 10:00 | Welcome and introduction |
| Sarah Le Merdy, Technology Manager, Clarification, Viral Safety, Merck KGaA, Darmstadt, Germany | |
| 10:00 - 11:00 | Virus risk mitigation in the development of biological medicinal products: a global regulatory perspective |
| Martin Wisher, Senior Director, Global Head of Regulatory Affairs, Bioreliance | |
| 11:00 - 11:45 | Parvovirus-retentive filter performance and removal mechanisms during process interruptions |
| David Bohonak, PhD, Senior Applications Engineer, Manufacturing Sciences and Technology, MilliporeSigma | |
| 11:45 - 12:30 | Screening and selection of prefiltration options prior to virus filtration |
| Jérôme Pezzini, DSP Breakthrough Technologies Manager, Sanofi | |
| 12:30 - 13:30 | Poster session and lunch |
| 13:30 - 14:15 | Differential retention of animal parvoviruses by virus filtration |
| Dr. Thomas Nowak, Senior Manager in Virus Safety Development, Global Pathogen Safety of R&D, CSL Behring | |
| 14:15 - 14:45 | Nanofiltration optimisation using micro-titer plates |
| Alison Tang, PhD, Downstream Development Scientist, MedImmune | |
| 14:45 - 15:30 | Overcoming filter fouling and virus breakthrough - Scale-down model qualification study |
| Shohei Kobayashi, Supervisor of Downstream Development, API Process Development Department, Chugai Pharmaceutical Co., Ltd. | |
| 15:30 - 16:00 | Poster session and break |
| 16:00 - 16:45 | Effect of product concentration on continuous parvovirus-retentive filtration |
| David Bohonak, PhD, Senior Applications Engineer, Manufacturing Sciences and Technology, MilliporeSigma | |
| 16:45 - 17:30 | Best practices for supplier initiated changes to virus clearance validated steps: virus filtration and chromatography resins |
| Michael O’Donohoe, PhD, Process & Technology Lead, Merck KGaA, Darmstadt, Germany Dawn MacNeill, Strategic Program Manager, Marketing Operations Filtration & Chromatography, MilliporeSigma | |
| 17:30 onwards | Evening event and networking dinner |
Wednesday, November 15
| 8:30 - 10:00 | Step into an M Lab™ Collaboration Center |
| Register to join us for a visit! | |
| 10:00 - 10:30 | Poster session and break |
| Viral inactivation | |
| 10:30 - 11:15 | Viral inactivation step and impact of REACH regulation for LFB products: efforts to address substitution to Triton X-100 |
| Caroline Goussen, Viral & TSE Clearance Studies Manager, LFB Biotechnologies | |
| 11:15 - 12:30 | Paradigm shift in detergent virus inactivation: a novel detergent virus inactivation technology for biologics production |
| Dr. Shengjiang Shawn Liu, Head and Principal Scientist, Pathogen Safety Department, Bayer | |
| 12:30 - 13:15 | Virus inactivation using chemicals: alternatives to Triton X-100 |
| Patricia Greenhalgh, Head of Virology Team, MilliporeSigma | |
| 13:15 - 14:00 | Poster session and lunch |
| Upstream related topics | |
| 14:00 - 14:45 | Risk based upstream viral clearance approach at Biogen |
| Aaron Mack, Engineer III, Materials Science, Biogen | |
| 14:45 - 15:45 | Defend your bioreactor: using nanofiltration to prevent virus contamination of cell culture processes |
| Christina Carbrello, Senior Scientist in Filtration R&D, MilliporeSigma | |
| 15:45 - 16:00 | Closing remarks |
| Sarah Le Merdy, Technology Manager, Clarification, Viral Safety, Merck KGaA, Darmstadt, Germany |
The life science business of Merck KGaA, Darmstadt, Germany operates as MilliporeSigma in the U.S. and Canada.
Space is limited, register now!
*Agenda subject to change. Attendance to the "2nd European Viral Safety Experts Forum" is limited and available to pharma or biopharma manufacturers and academics only. The offer does not extend to any company that provides pharma or biopharma products or services. We reserve the right to revoke or refuse participation at any time. The meeting is free of charge. Dinner, lunches, and coffee breaks are provided compliments of Merck KGaA, Darmstadt, Germany. Hotel accommodations and travel costs are at the expense of the attendees. A block of rooms has been booked at different hotels close to the meeting venue.
We are Now One
EMD Millipore + Sigma-Aldrich =
MilliporeSigma
The life science business of
Merck KGaA, Darmstadt, Germany