Kedrion’s dedication to the safety of its products, as well as to the safety and well-being of the people it serves, led it to establish its Biological Safety Centre (BioSC) in Italy. These laboratories conduct pathogen clearance validation studies on manufacturing processes according to Good Laboratory Practice (GLP).
BioSC specializes in studying the inactivation and removal of viral and non-viral pathogens in production of biological and biotechnological products including monoclonal antibodies, recombinant proteins, plasma-derived products and medical devices. It offers these highly regarded services to other producers and suppliers of such products in Italy as well as other countries:
- Polymerase Chain Reaction (PCR) testing, also known as Nucleic Acid Testing
- Identification of contaminants in cell cultures
- In vitro studies
- Protein characterization
- Process optimization
- Management/Good Laboratory Practices
- Regulatory compliance
The Centre anticipates expansion of the testing and research capacities offered externally by including more specialized tests such as for immunoneutralization, characterization of cell lines.
If you are interested in learning more about the services offered by BioSC, please contact us.