The Biological Safety Centre – BioSC, specialized in viral validation studies, more specifically “studies for inactivation/removal of viral and non-viral pathogens (prions) for biological and biotechnological productions” for in-house and outsourced services, has been opened. BioSC’s mission is to respond with full capabilities to the current and future requirements in terms of safety from biological contamination, with a view to the consistent innovation and continuous improvement of its services.
The new laboratories, which have been opened at Kedrion Group’s Bolognana (Lucca) plants, respond to the double goal of making Kedrion independent in its safety studies that had been commissioned to external laboratories so far and becoming a national and international safety landmark for all those who need to conduct viral validation studies on their products or processes (manufacturers and suppliers of biological and biotechnological products and devices or auxiliary products to be used in biological and biotechnological productions).
Viral validation studies are the core business (selection and analysis of raw materials, product analysis at appropriate stages of the production process, verification of method’s ability to inactivate and/or remove contaminant pathogens), and some services developed for viral validation processes are available for individual applications (PCR tests – GMO search, tests for the detection of contaminants in cell cultures used in bio-pharmaceutical productions, development of and advice on PCR methods, advice on analytical statistical methods, cell culture characterization).
The facility, which has recently received the GLP (Good Laboratory Practice) certification from the Health Ministry, is the result of the sound experience gained by Kedrion in the area of plasmaderivatives safety, the expertise it gained through its cooperation with leading industry partners and international regulatory bodies, such as EMA and FDA, and first and foremost the highly skilled staff trained by Kedrion who work in compliance with the most innovative quality and safety procedures.
«The studies we have been engaged in since the mid-2009 – explained Claudia Nardini, Industrial Development & Research Director at Kedrion and Test Facility Director at BioSC – are focused on the investigation of the process steps in order to prove their effectiveness in removing prions, currently acknowledged as pathogens representative of unknown contaminant agents, in other words agents that, according to European and American industry guidelines, are to be associated with very complex scenarios as hard-to-diagnose pathogens».
«We are the only company in Italy and one of the few in Europe that can provide such service – concluded Claudia Nardini – and what makes us stand out most as a safety centre in support of regulatory bodies, is our established knowledge of the current scenario and our keen outlook on future scenarios».
For info on BioSC, email [email protected]