Virus Safety Services

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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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