Property, plant and equipment
Our corporate offices and research activities are located in facilities of approximately 8.700 square meters in Leiden, the Netherlands. The section of this building that we use in Leiden includes 3.500 square meters of laboratories, with BioSafety Level (BSL) 1, BSL 2 and BSL 3 labs. The remainder of the main building is divided into 2,800 square meters of office space and 2,400 square meters for storage, technical areas, washrooms, waste destruction and sterilization.
In addition, we lease 1200 square meters of space adjacent to the corporate main building. In 2007 we closed our pilot plant and production facility, which was located in a separate building in the Leiden BioScience Park.
In 2005, we began to construct a new GMP Process Technology Center of 5.400 square meters in Leiden. This new facility will be a BioSafety Level (BSL) 3 facility, in which two concurrent products can be produced, on either BSL 2 and/or BSL 3 safety level. The building will consist of 1,500 square meters of production space; 220 square meters of quality control labs; 185 square meters BSL 3 research and development labs; 80 square meters filling (up to 2,000 ampoules); 40 square meters of buffer and medium preparation; 310 square meters of offices; 350 square meters of
storage and 2,715 square meters for utilities, washing area, waste destruction and sterilization and technical areas.
The new centre is named after Crucell co-founder Dinko Valerio, and is known as PTC Valerio Building. The PTC Valerio Building will give us 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 installed. There is also room for expansion, with multiple 100-liter wave-bags, disposable stirred tank bioreactors, and large scale 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. The facility must receive approval from the Dutch government 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.
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The facility is currently scheduled to become operational in the first half of 2008.
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Since our 2006 acquisitions, we also have office space, laboratories, production facilities, pre-clinical facilities and storage space in Switzerland, Spain, Germany, Sweden and Korea.
The following table sets out information regarding our main facilities outside the Netherlands:
Bern, Switzerland
(two locations)
Research and development
(including pre-clinical facilities)
8,618 m2 and production facilities
(12,427 m2); office space
(5,635 m2) and storage
buildings (15,988 m2) (owned)
Madrid, Spain
Production facilities
(1600 m2), storage buildings
(2400 m2) and office space/labs
(1409 m2) (owned)
Seoul, Korea
Development and
production facilities
(2,201 m2), pre-clinical facilities
(999 m2), storage facilities
(1,305 m2), office space
(1,819 m2) (leased until 2010)
Stockholm, Sweden
Development and
production facilities
(4,866 m2), pre-clinical facilities
(1606 m2), storage facilities
(5,990 m2), office space
(2,662 m2) (leased until 2020)
Our manufacturing facilities in Switzerland are FDA/EMEA-approved and are used primarily for the production of Inflexal V, Vivotif, Epaxal and mammalian cell culture-based products. One of our facilities also includes facilities for lyophilization and a Center of Mammalian Cell Culture, which is currently not in use.
Our manufacturing facilities in Korea are World Health Organization-approved and are used primarily for the production of Quinvaxem and Hepavax-Gene and for formulating and filling vials. The manufacturing process used at our Korean facilities are based on the patented Hansenula polymorpha yeast expression technology.
In Spain, the center of our European filling and packaging operations, we operate a filling line for syringes.
In Sweden, our manufacturing facilities are EMEA/WHO-approved and are used for the production of Dukoral and the recombinant protein rCTB.
In 2007 € 27,156 was invested in property, plant and equipment compared to € 20,337 in 2006. The investments in 2007 mainly related to our new GMP production facility in Leiden, the Netherlands and investments in our facilities in Bern, Switzerland that will improve current production processes and allow in-house production of materials currently acquired from third parties.
In 2006 € 20,337 was invested in property, plant and equipment compared to € 17,137 in 2005. Investments were mainly related to building and equipping our new GMP production facility in Leiden, the Netherlands.