Pentlands Facility

The facility at Pentlands Science Park, near Edinburgh, includes fermenters for the production of materials using mammalian cells. This facility was custom built in 1985,  has a total area of 780 sqft and consists of three rooms:

• Tissue culture with hot room
• Fermentation room
• Downstream processing and manual fill room
  

The facility has had a license for cGMP manufacture since 1996. The facility was licensed by the Medicines and Healthcare Products Regulatory Agency (MHRA) in July 2005 under the European Clinical Trials Directive (2001/20/EU). This license specifically states that Angel can manufacture autologous and stem cells for use in clinical trials. All clinical trials within Europe are subject to the requirements of this directive and Angel's Manufacturing Licence for Investigational Medicinal Products (IMPs) authorizes Angel to manufacture biopharmaceuticals to be used in clinical trials.

As well as having a license from the MHRA, the facility at Pentlands Science Park is licensed by the Human Tissue Authority (the HTA) which regulates the storage, use and disposal of human tissue in the UK.