Register for our Live Webinar:
Tuesday, April 16, 2024 | 11am EDT | 8am PDT | 5pm CET
Event Overview
Tuesday, April 16, 2024 | 11am EDT | 8am PDT | 5pm CET
Event Overview
Ensuring that viral clearance studies achieve the needed log reduction values (LRV) or viral reduction values (VRV) for regulatory requirements is critical in avoiding delays in clinical trials or manufacturing schedules. While researchers and contract manufacturing organizations (CMOs) may be knowledgeable about their specific molecules and purification processes, they often lack comprehensive understanding of the various factors influencing virus selection for clearance studies.
The selection of specific viral strains, ideally a non-human infectious model virus, is critical to ensuring the viral challenge to the purification evaluation is representative of endogenous or introduced viral contaminants. The chosen strains must also align with regulatory guidelines based on intended filing location, product development stage, and exposure risks. Additionally, the evaluation of viral clearance should consider worst-case scenarios, including factors such as time, temperature, pH, and robust virus titers.
The critical aspects of viral clearance studies are essential for meeting regulatory standards and preventing delays in clinical trials or manufacturing. Join our webinar as we explore:
- Understanding the significance of achieving log reduction values or viral reduction.
- Identifying common gaps in knowledge among researchers and contract manufacturing organizations.
- Importance of selecting appropriate viral strains, including non-human infectious models.
- Consideration of worst-case scenarios in viral clearance evaluation.
- Balancing minimal virus volume with maximum challenge by adjusting environmental and solution matrix conditions.
- Highlighting crucial components of viral clearance studies to ensure successful outcomes and regulatory compliances.
Presenters:
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Noah Horn Manager Eurofins BioPharma Product Testing |
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As a Manager of BioPharma Viral Clearance at Eurofins BioPharma Product Testing, Noah Horn is experienced with the breadth of the vaccine development pipeline from R&D genome editing and vaccine design to purification in process development. Noah has over ten years’ experience working in various aspects of biological product development. In his nearly five years with Eurofins, he has operated in several capacities from performing viral clearance studies in the lab as a scientist to overseeing the viral clearance team as manager . Noah holds a B.S. in Biology from Grove City College.
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Alex Rodriguez Scientific Group Leader II Eurofins BioPharma Product Testing |
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Alex Rodriguez is a Scientific Group Leader II with Eurofins BioPharma Product Testing’s Viral Clearance team and has over 5 years of experience performing and overseeing viral clearance studies. He has first-hand knowledge of sample generation at lab-scale purification processes all the way down to endpoint assay inoculation and quantification of results. Alex regularly consults with clients on ongoing studies and offers support to the in-lab teams executing clearance assays. Alex holds a B.S. degree in biology from Cornell University.
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Register for our On Demand Webinar
Event Overview
Ensuring that viral clearance studies achieve the needed log reduction values (LRV) or viral reduction values (VRV) for regulatory requirements is critical in avoiding delays in clinical trials or manufacturing schedules. While researchers and contract manufacturing organizations (CMOs) may be knowledgeable about their specific molecules and purification processes, they often lack comprehensive understanding of the various factors influencing virus selection for clearance studies.
The selection of specific viral strains, ideally a non-human infectious model virus, is critical to ensuring the viral challenge to the purification evaluation is representative of endogenous or introduced viral contaminants. The chosen strains must also align with regulatory guidelines based on intended filing location, product development stage, and exposure risks. Additionally, the evaluation of viral clearance should consider worst-case scenarios, including factors such as time, temperature, pH, and robust virus titers.
The critical aspects of viral clearance studies are essential for meeting regulatory standards and preventing delays in clinical trials or manufacturing. Join our webinar as we explore:
- Understanding the significance of achieving log reduction values or viral reduction.
- Identifying common gaps in knowledge among researchers and contract manufacturing organizations.
- Importance of selecting appropriate viral strains, including non-human infectious models.
- Consideration of worst-case scenarios in viral clearance evaluation.
- Balancing minimal virus volume with maximum challenge by adjusting environmental and solution matrix conditions.
- Highlighting crucial components of viral clearance studies to ensure successful outcomes and regulatory compliances.
Presenters:
|
Noah Horn Manager Eurofins BioPharma Product Testing |
|
As a Manager of BioPharma Viral Clearance at Eurofins BioPharma Product Testing, Noah Horn is experienced with the breadth of the vaccine development pipeline from R&D genome editing and vaccine design to purification in process development. Noah has over ten years’ experience working in various aspects of biological product development. In his nearly five years with Eurofins, he has operated in several capacities from performing viral clearance studies in the lab as a scientist to overseeing the viral clearance team as manager . Noah holds a B.S. in Biology from Grove City College.
|
|
|
Alex Rodriguez Scientific Group Leader II Eurofins BioPharma Product Testing |
|
Alex Rodriguez is a Scientific Group Leader II with Eurofins BioPharma Product Testing’s Viral Clearance team and has over 5 years of experience performing and overseeing viral clearance studies. He has first-hand knowledge of sample generation at lab-scale purification processes all the way down to endpoint assay inoculation and quantification of results. Alex regularly consults with clients on ongoing studies and offers support to the in-lab teams executing clearance assays. Alex holds a B.S. degree in biology from Cornell University.
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