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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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PCI Pharma Services Announces Appointment of Angi Calkins as Chief Human Resources Officer
Philadelphia, PA – January 28, 2019. Leading biopharmaceutical services provider PCI Pharma Services (PCI) is pleased to announce the appointment of Angi Calkins as Senior Vice President and Chief Human Resources Officer. Angi joins PCI as the company experiences considerable growth and global expansion, currently with more than 3,500 associates, spanning eight locations comprised of 20 facilities across three continents. PCI features a broad portfolio of outsourced development and commercialization services focused in drug development and manufacturing, clinical trial supply, as well as commercial contract packaging.
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White Papers |
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Translating Cancer Genomics Into A Personalised Approach For Cancer Patients
PRA Health Sciences (PRA)
Over the past few decades, the approach to prevention, diagnosis and treatment of cancer has radically shifted from organ-based to morphology-based and most recently, to genetics-based. Personalized or precision medicine (tailoring a treatment for a patient’s particular disease at a precise time point) is being performed every day at different levels in the clinical setting.
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Industry Events |
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SMi Presents the 11th Adaptive Designs in Clinical Trials Conference 2019
1-2 April 2019, Holiday Inn Kensington Forum, London
SMi Group are proud to announce the 11th annual Adaptive
Designs in Clinical Trials conference and exhibition will return to London from
the 1st – 2nd April 2019. With the growing popularity in use and acceptance of
adaptive designs in clinical trials - demonstrated most recently with the new
FDA draft guidance on adaptive designs – there is a pressing need for a forum
which explores this increasingly normalized medical methodology.
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