Leiden, The Netherlands, October 5, 2006 - Dutch biotechnology company Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) today announces the placement of the first module of its new GMP ('Good Manufacturing Practices') Process Technology Center next to Company headquarters in Leiden. The core of the facility is made up of 64 pre-fab modules, constructed off-site in Germany by technology service provider Pharmaplan, a Fresenius ProServe company. The new Center is to take the name of Crucell co-founder Dinko Valerio, becoming the 'Valerio Building'.

 

The Valerio Building will give Crucell the in-house capability to support vaccine, protein and monoclonal antibody process design and development, minimizing requirements for outsourcing. Bioreactors (of 2, 10, 30 and 100 liter capacities) have already been constructed off-site and are ready for installation. There is also room for expansion, with (multiple) 100-liter wave-bags, large scale DSP (Down Stream Processing) equipment and scale-up of fill and finish capacity.

 

When fully operational, the Valerio Building will meet the highest environmental and safety standards recommended for the laboratory activities to be conducted there, standards known as Biosafety Levels 2 and 3 (BSL-2 and BSL-3). In addition, the facility must receive approval from the Dutch government and the US Food and Drug Administration (FDA) to produce material for use in humans. Extensive precautions will be taken to ensure safety and continuity of operations. Product quality will be strictly monitored, maintained and administered in-house. The core project team has approximately 800 documents to write before the facility can qualify to become operational. This is currently scheduled for the end of 2007.

 

The Valerio Building will be a state-of-the-art Center of Excellence. "It is more like a production laboratory than a production facility per se," says project leader Nanda Doornik. "When operational, Crucell will be able to substantially increase its production capabilities. It is the only building of its kind in the world, providing an important tool for attracting talent to Crucell."

 

About Crucell

Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) is a biotechnology company focused on research, development and worldwide marketing of vaccines and antibodies that prevent and treat infectious diseases. Its vaccines are sold in public and private markets worldwide. Crucell's core portfolio includes a vaccine against hepatitis B and a virosome-adjuvanted vaccine against influenza. Crucell also markets travel vaccines, such as the only oral anti-typhoid vaccine and the only aluminum-free hepatitis A vaccine on the market. The Company has a broad development pipeline, including both early-stage products and products almost ready to go to market. Several Crucell products are based on its unique PER.C6® production technology. The Company licenses this and other technologies to the biopharmaceutical industry. Important partners and licensees include DSM Biologics, sanofi aventis, GSK and Merck & Co. Crucell is headquartered in Leiden (the Netherlands), with subsidiaries in Switzerland, Spain, Italy and Korea. The Company employs about 900 people. For more information, please visit www.crucell.com.