Facilities
The facility is located in the Novum research park and has a total area of 740 sqm out of which the laboratory occupies 300 sq. m. Adjacent area of 440 sq. m is for storage, offices and general purpose uses. The incoming air as well as all outgoing air to the production unit and the laboratory passes through HEPA filters (High Efficiency Particle Absorbtion). The production unit for viral vectors has its own HEPA filters and air ducts in order to prevent any cross contamination. The HEPA filtered air is
exchanged 25 times per hour and the pressures are adjusted in order to get the lowest pressure in the lock to the viral vector unit and the laboratory with an underpressure in the cultivation rooms.
The production facilities were constructed according to BL2 (Biological safety level 2) which were facilitated by the separate construction inside the main building. In this way it was possible to select proper materials for walls, ceilings, floor and the containment required could be achieved independently of the enclosing building. A service floor with equipment for aeration, air filters and utilities could also be built above the production facilities. The production unit for viral vectors consists of three cultivation rooms connected to a common lock where two rooms are intended for cultivation in flasks and roller bottles and the third room for cultivation in a bioreactor. A preparation room for in and outgoing materials is located between the main lock to the unit and the lock to the cultivation rooms.
The production unit for plasmids consist of a cultivation room with a shaker, a fermentor and a centrifuge for harvesting and a separate room for preparation of pure plasmids. The two rooms are connected to a common lock accessible from the laboratory. The QC laboratory is also accessible only through a lock.
Vecura
Clinical Research Center, Karolinska University Hospital Huddinge,
SE-141 87 Stockholm, Sweden
Tel +46 8 58 58 38 43,
Fax +46 8 58 58 38 45
info@vecura.com
Updated: Tuesday, April 5, 2005 21:11