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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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The Latest Innovations in HPAPI Manufacturing Technologies
SMi’s inaugural Highly Potent Active Pharmaceutical Ingredients USA Conference, will focus on the latest innovative manufacturing technologies with a special spotlight presentation on effective and safe containment solutions for biologics based HPAPIs, along with cleaning and cross contamination requirements.
More info >> |
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White Papers |
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Spotlight on Quality in Study Startup
Oracle Health Sciences
This white paper addresses the growing interest in quality in clinical trial execution and how workflows play an essential role by building in the steps needed to comply with TMF guidelines, reducing downstream problems. This proactive strategy limits issues caused by siloes, yielding process improvements measurable by performance metrics.
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Industry Events |
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The Universe of Pre-filled Syringes and Injection Devices
22-23 October 2019, The Swedish Exhibition & Congress Centre Gothia Towers Hotel
PDA’s Universe of Pre-filled Syringes and Injection
Devices has become the must-attend meeting for everyone
working in the field, and is now the world’s largest conference on this subject
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