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08:25 08:30 (5 mins)

Main agenda

Chairperson's Opening Remarks

  • Marie Murphy - Microbiologist, Biotechnology Operations , Eli Lilly and Company, Ireland

08:30 09:30 (60 mins)

Main agenda

Breakfast briefing: Regulatory strategies and considerations for viral safety and raw materials

This will be a session of 1hr 10 minutes, in which a panel of regulators and health authorities will interact with the audience and respond to regulatory concerns. All attendees and speakers will be asked to send their questions in anonymously in advance of the meeting.

Topics to be discussed include:

  • Virus seed and harvest testing
  • Raw material testing
  • Viral Clearance
  • Virus testing
  • Inactivation: incl. column re-use and cleaning studies
  • Prion testing Vs. TSE Risk
  • Viral safety and raw material testing for non-traditional products i.e. ATMPs etc.
  • Arifa Khan - Senior Investigator, FDA/CBER
  • Albert Stühler - Deputy Head, Virus Safety, Paul-Ehrlich-Institut

09:30 09:55 (25 mins)

Main agenda

Comparison of virus retentive filter performance in viral clearance studies and unusual performance issues

In viral clearance studies, virus retentive filter performance issues are still observed even with the use of highly purified virus stocks, improved experimental set-ups and pre-filters. Based on our internal database, we analyzed the overall performance of different filters looking specifically for filter blockage and virus breakthrough. Some cases with unusual performance issues, the possible causative reason and how the obstacles could be overcome will be presented as well.

  • Anja Tessarz - Viral Clearance Study Director, Charles River, Germany

10:00 10:45 (45 mins)

Main agenda

Morning Coffee

10:45 11:15 (30 mins)

Main agenda

Virus inactivation by disinfection and sanitization – Do we really know?

  • Johanna Kindermann - Senior Scientist, Shire, Austria

11:15 11:45 (30 mins)

Main agenda

Viral and TSE risk assessment considering production systems of recombinant proteins

  • Juergen Blusch - Scientific Expert, BTDM Technical Development Quality, Novartis Pharma AG, Switzerland

11:45 12:15 (30 mins)

Main agenda

Strategies for minimizing adventitious virus risk

Regulatory guidelines have shaped industry best practices around adventitious virus contamination risk mitigation in terms of patient safety. A recent survey indicated that the cost to remediate a virus contamination can run into millions of dollars, not including commercial impact. Today, the industry is taking a closer look at minimizing the business risk associated with viral contaminations and is taking a more holistic view of risk mitigation. This approach includes virus prevention and detection in addition to removal. From cell culture seed train to final fill vial, the discussion will describe the potential risks associated with different areas of biotech processes and what can be done to minimize adventitious virus risk in those areas. The overarching strategy of risk mitigation will include evaluation of raw materials, modified expression systems, environmental controls, upstream and downstream processing, testing and regulatory considerations.

  • Alison Armstrong - Senior Director, Global Head of Field Development Services, Merck BioReliance® Services, UK

12:15 13:30 (75 mins)

Main agenda


13:30 14:00 (30 mins)

Main agenda

Scientific review on the changes in the EMA – TSE Guidance

  • Review of scientific basis for changes to the EMA guidance on TSE
  • What amendments are being looked at/made?
  • Draft expected Q4 2016

14:00 14:30 (30 mins)

Main agenda

Novel virus filter design to overcome the challenges of continuous processing

Recent studies in virus retentive filtration have changed our perception of the worst case scenarios for maximizing virus safety, with low flow and pressure interruptions increasing risk. We link fundamental understanding to filter design in order to open up the opportunity of optimal continuous processing at low flow.

  • Nigel Jackson - Principal Engineer R&D, PALL Life Sciences

14:30 15:00 (30 mins)

Main agenda

Risk assessment for Prions: What method to apply?

  • Mark Plavsic - Chief Technology Officer, Lysogene, USA

15:00 15:30 (30 mins)

Main agenda

Robust Virus Filter for Your Process

The presentation will elaborate on 3 different aspects of robustness such as 1) virus removal capabilities, 2) filtration flux/capacity and 3) quality of virus filters. Why is this critical and essential at R&D and industrial/commercial stages?

  • Sebastian B. Teitz - Product Manager, Asahi Kasei Bioprocess

15:30 16:00 (30 mins)

Main agenda

Afternoon Coffee

16:00 16:30 (30 mins)

Main agenda

Emerging viruses: Ensuring the correct processes are in place

  • Zika 
  • Safety relative to plasma derived products
  • Detection methods
  • Epidemiology of the virus

  • Bjoern Keiner - Senior Manager, Virus Safety Development, CSL Behring, Germany

16:30 17:00 (30 mins)

Main agenda

Risk assessment for plasma-derived medicinal products: application to HEV and ZIKV

  • virus inactivation/removal steps in plasma products manufacturing processes
  • model viruses approach for ZIKV
  • HEV reduction in manufacturing processes
  • Benoit Flan - Director, Viral Safety Biologics, LFB

17:00 17:05 (5 mins)

Main agenda

Chairperson's Closing Remarks

17:05 17:05 (0 mins)

Main agenda

End of Conference