The Emmen Manufacturing Facility
Vaccinogen has a plant in Emmen, Netherlands for the manufacture of OncoVAX®. The Dutch National Institute of Public Health and Environmental Protection (“RIVM”) has approved Vaccinogen’s sterile vaccine manufacturing process. On July 23, 2013, the Dutch Ministry of Health, Welfare and Sport (“VWS”) performed a formal inspection on the manufacturing facility.
The Vaccinogen BV manufacturing group in Emmen, The Netherlands, passed its previous inspection in 2010 and subsequently received a certificate of cGMP. Based on the July 23, 2013 inspection result, the cGMP certification has been reestablished.
This 900-m² (9600 ft²) facility has five class C manufacturing suites and two class B quality control laboratories with a capacity to produce 2,000 OncoVAX® vaccines per year – a production amount sufficient to cover the pivotal phase IIIb clinical trial and the initial European sales, as authorizations permit.