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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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Turkish Cargo keeps growing in the first quarter of 2019
Maintaining its accomplished operations from Ataturk and Istanbul airports as "Dual Hub", the global brand of Turkish Cargo continued its strong growth momentum during the first quarter of the year despite the shrinkage of the global air cargo sector.
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White Papers |
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Detecting Integrity Breaches in a range of Pharmaceutical Blister Package Types using Sepha VisionScan
Sepha Limited
Demonstrating the integrity of pharmaceutical blister packs is critically important, as any defects can affect the shelf life and efficacy of the contents. Compared to bulk packaging, blister packs offer improved product integrity, tamper evidence and reduce the likelihood of misuse. Packs can be composed of either a thermoformed polymer or cold formed aluminium tray, with a number of individual pockets to hold the product. After the tablets or capsules are placed in the pockets, the packs are heat sealed with a paper or foil laminate sheet. These various stages can be completed separately or integrated into a single form, fill and seal process. There is a risk of microbial containment or degradation of the contents if any defects are present in the packaging. Such defects can take the form of rips or pinholes in the tray, or lid materials, faulty seals and channel leaks between pockets.
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Industry Events |
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SCOPE Summit for Clinical Ops Executives
18-21 February 2020, Hyatt Regency, Orlando, Florida, US
Celebrating its 11th successful year,
SCOPE Summit 2020 takes place February 18-21 in Orlando, FL. Over the course of
four stimulating days of in-depth discussions in 20 different conferences, 3
plenary keynote sessions, the annual Participant Engagement Awards, and the
ever-popular interactive breakout discussions, the programming focuses on advances
and innovative solutions in all aspects of clinical trial planning, management
and operations
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