Pharmaceutical Services

Pharmaceutical Services (SPS) is a business unit specialized in a broad array of pharmaceutical services aiming at the development and quality testing of biologicals intended for therapeutical application in humans. These services include the development of adequate production processes, contract production of mammalian cell products (monoclonal antibodies and/or r-DNA) as well as safety testing and designing validation studies for assays and processes, including viral reduction studies.

Contract production

Pharmaceutical Services has ample experience in designing production strategies and scaling up of production in compliance with EU and FDA guidelines. For this purpose, SPS holds a GMP-license for the production of clinical grade pharmaceuticals including large scale fermentation, purification and sterile filling. The use of a specially developed serum-free culture medium in fermentation, guarantees a process free of concerns related to the transmission of pathogens such as prions and mammalian viruses. Several generic purification schemes for different types of proteins are available, allowing Pharmaceutical Services to provide their clients already in an early stage of development with a validated process. In their multipurpose plant several projects can be handled simultaneously, allowing for fast turn around times.

Biosafety testing

Pharmaceutical Services is also experienced in conducting a broad array of biosafety tests required for the pharmaceutical release of biotech products in compliance with both EU and FDA guidelines. For this purpose, all assays have been GCLP (Good Control Laboratory Practice) accredited. Other QC services such as protein characterization, stability test programs, formulation studies and as well as the validation of client based assays are part of their dedicated activities.

Virus and prion validation studies

Virus Safety Services (VSS) is a separate unit within Pharmaceutical Services dedicated to conducting virus and prion validation studies of plasma-derived products and other biologicals. VSS has extensive experience in validation of various process steps, including the more delicate ones, like column and nanofiltration steps. VSS uses for their activities state-of-the art BSL3 facilities, including strict separation between virus negative and virus positive areas. An Endorsement of Compliance with the OECD principles of GLP based on assessments performed according to the Netherlands GLP Compliance Monitoring Program and according to Directive 2004/9/EC was granted for these activities in 2005. VSS provides tailor-made solutions for virus validation problems using a broad range of virus systems, which meet with the latest requirements of national and international regulatory bodies. The following virus systems are available:

More information may be found on the Sanquin Pharmaceutical Services Home Page.