The CellMa Advanced Therapies Clean Room is a facility with highly specialised infrastructure for the manufacture of sterile medicines for human use, whose active ingredient consists of somatic cells (Somatic Cell Therapy).
For the proper development of its activity it must comply with the requirements imposed by the European Medicines Agency (EMA). In addition, the manufacture of sterile medicines is covered by the Pharmaceutical Quality System of Good Manufacturing Practices (GMP), which is governed by the European Regulation EudraLex Volume 4, more specifically by Part IV “GMP requirements for Advanced Therapy Medicinal Products”. The use of these Advanced Therapies is covered by Regulation (EC) No. 1394/2007 of the European Parliament and Directive 2009/120/EC.
The CellMa Clean Room has an area of 75m2 that is distributed in three changing rooms, a communicating corridor, three processing rooms, a quality control laboratory and a warehouse. A multipurpose room, cryogenics room and specific high-end equipment enhance the functionality of the CellMa Clean Room.
Recently, the approval of the facilities and the monitoring system of the CellMa Clean Room has been obtained and the last stage of the implementation of the GMP Pharmaceutical Quality System has begun, hoping that said facility can be certified this very year by the Spanish Medicines Agency (AEMPS) as a Cell Therapy Clean Room.
C/ Irunlarrea 3
Navarrabiomed-Centro de Investigación Biomédica
Complejo Hospitalario de Navarra
31008 Pamplona, Navarra. España