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Virus Safety Services

Virus Safety Services (VSS) as part of the Sanquin business unit ' Sanquin Pharmaceutical Services' has more than twenty years experience in performing virus validation studies of cellular blood products, plasma-derived products, and other biologicals. VSS offers a complete range of virus systems compliant with the latest requirements of international regulatory bodies. VSS has ample experience with validation of various process steps, including the more delicate ones, like column and nanofiltration steps. VSS has state-of-the art biosafety level (BSL) 3 facilities, including strict separation between virus negative and virus positive areas. All projects are performed according to the principles of Good Laboratory Practices.

Why working with us?
  • more than twenty years of experience in virus validation studies
  • familiar with safety issues as being part of a product producing organisation
  • state-of-the-art facilities comprising BSL 3 level laboratories
  • GLP compliant

    Providing tailor-made solutions for virus validation issues
  • detailed information on the virus reducing capacity of process steps studied
  • dedicated experimental designs for demonstrating robustness
  • accurate insight into viral safety of a product

    Compliant with the latest requirements of international regulatory bodies
  • Note for guidance on plasma-derived medicinal products (CPMP/BWP/269/95 rev. 3, London, 25 Jan. 2001)
  • Note for guidance on virus validation studies: The design, contribution and interpretation of studies validating the inactivation and removal of viruses; Revised (CPMP/BWP/268/95, London, 14 February 1996)
  • Viral Safety Evaluation of Biotechnology Products Derived from Cell lines of Human or Animal Origin (CPMP/ICH/295/95)

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    • Virus Safety Services
    Sanquin Pharmaceutical Services
    Plesmanlaan 125
    1066 CX Amsterdam-NL

    Secretariat:
    Telephone: + 31 20 512 3549
    Fax: + 31 20 512 3550

    E-mail: pharmaceutical.services@sanquin.nl

    GLP Compliant
    Food and Consumer Product Safety Authority (VWA) of the Dutch authorities have granted an Endorsement of Compliance with the OECD principles of GLP at December 09, 2005 for the Sanquin Virus Safety Services Laboratory based on assessments performed according to the Netherlands GLP Compliance Monitoring Programme and according to Directive 2004/9/EC. Click here for the status list of the laboratory and search for Sanquin.



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