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| home > white papers > Planning the Execution of a Viral Clearance Study - Eurofins BioPharma Product Testing |
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 WHITE PAPERS |
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Eurofins BioPharma Product Testing
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Planning the Execution of a Viral Clearance Study
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Viral clearance studies are a necessary component of any regulatory submission for clinical trials or commercial product approval for all biopharmaceutical products. These studies are performed to evaluate the capability of the purification process to remove or inactivate viruses that could potentially contaminate the starting material. They are complex studies that require substantial financial and personnel resources, as well as specialized scientific expertise to perform. As such, viral clearance studies are often performed at a qualified contract testing laboratory rather than in-house. When multiple parties are involved in this process, clear communication and a comprehensive understanding of the approach and timeline is critical.
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News and Press Releases |
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Reify Health Raises $220 Million to Eliminate Waiting in Clinical Trials
Reify Health
today announced a $220 million Series C funding round led by Coatue
Management, joined by ICONIQ Growth and Adams Street Partners, as well
as existing investors Sierra Ventures and Battery Ventures.
More info >> |
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White Papers |
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New Temperature Profiles from a Global Study
Laminar Medica
Recently there has been an influx of temperature
mapping studies to collect sufficient ambient data to develop temperature
profiles. Solid temperature profiles on
specific shipping routes are required to ensure streamlined packaging and robust
lane qualification.
The most reliable method to develop
temperature profiles is to capture the actual reading from shipments, as well
as using the historical and meteorological data to increase the confidence
level.
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