2019 PDA Virus Safety Forum

8:45 a.m. – 10:30 a.m.  
P1: Virus Testing and Detection: Conventional Assays and New Technologies
Moderator: Dominick Vacante, PhD, Scientific Director, Janssen R&D, LLC

Strategies to mitigate risk of adventitious viruses in biologics include: using qualified raw materials; incorporating steps during the manufacturing for viral clearance; and extensive testing at various steps in the manufacturing process with the greatest potential for detection of contamination. Testing is aimed at detection of both known and unknown viruses. Broad virus detection is particularly important for safety of live products, since their manufacturing cannot generally include steps for viral inactivation and removal. Although the conventional assays have generally been effective for demonstrating absence of adventitious viruses, they are not sufficiently broad to detect known, unexpected viruses, and viruses that are distant to known viruses or novel viruses. This session will present perspectives on using conventional assays and next generation sequencing technologies for adventitious virus detection in biologics.

1. Considerations for Validating Virus Filtration in Continuous Bioprocessing Applications
   Ross A. Turmell, Senior Scientist, Pall Corporation
2. Alternative Detergents for Viral Inactivation
   Gabriella T. Perell, PhD, Postdoctoral Process Development Fellow, Amgen
3. Beyond Animal Testing: Accelerating Cell Line Characterization by Replacing MAP/HAP with a Rapid Degenerate PCR and Fragment Analysis Sequencing Method 
   Afshin Sohrabi, PhD, Head Molecular R&D, MilliporeSigma

11:15 a.m. – 12:45 p.m.   
P2: Viral Mitigation: Critical Evaluation of Current Practice
Moderator: Veronica L. Fowler, PhD, Senior Virologist, Merck & Co., Inc.

Viruses are the most abundant class of biological entity on Earth. Did you know that your genome is part viral, and that you are persistently infected with at least two viruses as you read this? Viral contamination in pharma is reality, illustrated by numerous high-profile events. Prevention is governed by the robustness of viral mitigation strategies, and the viral awareness of the people involved.

Within this exciting session, presenters will share case study experiences of their companies’ approach to the control of viral contamination, in terms of:

• Prevention assumptions drawn from the control strategy
• Critical evaluation of the risk mitigation
• Identification of remaining risks
• Strategies for addressing remaining risks

2:15 p.m. – 3:45 p.m.
P3: Virus Clearance: The Central Pillar of Pathogen Safety
Moderator: Sebastian B. Teitz, PhD, Scientific Coordinator, ASAHI Kasei Bioprocess

Impactful and tragic pathogen contamination events in the past lead us, the biopharma industry, into embracing a comprehensive virus safety strategy, commonly referred to as the “safety tripod” consisting of selecting, testing and clearance. The clearance pillar alone typically contributes an estimated 10,000-fold increase in safety assurance as compared to the pillars of selecting and testing combined.

This session will look into the state-of-the-art technologies and the future of protecting patients from virus transmission through sound virus clearance concepts.

4:30 p.m. – 5:30 p.m.  
P4: Think Tank: Practical Considerations and Applications for Viral Safety Challenges
Moderator: Brian J. Hawkins, PhD, Chief Technology Officer, Pluristyx, Inc.

In this session, panel members and the audience will engage in discussions on advancements in virus detection technologies and methods for viral inactivation and removal, and their implementation and applications to mitigate risk of virus contamination in different biological products. Technologies to prevent potential virus contaminants entering the process stream will also be discussed.