Specialist Viral Testing Service

The UKSCB is part of the Medicines and Healthcare products Regulatory Agency (MHRA). The UKSCB requires an external contractor (third party) to provide viral testing for the EU Tissue and Cellular Directive (EUTCD) compliant human pluripotent stem cell (hPSC) lines. UKSCB is licenced under the HTA Human Tissue (Quality and Safety for Human Application) Regulations 2007 for the production of starting materials for clinical application. According to HTA regulations any testing activities that are subcontracted to external contractors must be appropriately validated to demonstrate that the testing method is suitable for the product analyte.