MANUFACTURING
Fluart Innovative Vaccines manufactures its seasonal or optionally its pandemic influenza virus vaccines meeting the GMP (Good Manufacturing Practices) principles and a high level of product safety.
The seasonal vaccine is manufactured on the basis of the H1N1, H3N2 and B virus strains as seasonally recommended by the World Health Organization and the European Union.
The 3Fluart seasonal vaccine is a trivalent vaccine that contains an inactivated, whole virion, and an aluminum-phosphate adjuvant. The vaccine contains an active substance of 6µg HA/0.5ml of each virus strain.
The manufacturing of the vaccine requires special expertise since the production technology ensures safe procession of the whole virion, which includes special propagation, purification, separation, and formulation.
The applied aseptic production technology, the available pharmaceutical environment as well as several decades of professional experience guarantee a high level of product safety, and quality that meet the regulations.
One of the greatest microbiological collections of the world, the American Type Culture Collection (ATCC), classifies microorganisms and the related products according to the biosafety level (BSL) required for their delivery and procession.
There are 4 classes based on the risks they represent. (BSL-1: Biological active substances that do not pose or pose very little potential hazard to laboratory personnel and the environment; BSL-2: Biological active substances that pose moderate potential hazard to laboratory personnel and the environment; BSL-3: Biological active substances that cause serious or potentially lethal hazard disease via inhalation route; BSL-4: Hazardous and special biological active substances that pose the highest hazard to personnel and the environment. They usually cause lethal infection).
The manufacturing area and environment for the seasonal influenza vaccine require BSL-1 or maximum BSL-2 biosafety levels. In case of pandemics (epidemics caused by infectious disease) the manufacture might require contact with a virus strain that belongs to BSL-3 biosafety level. Our manufacturing processes and environment are established so that they are suitable for vaccines that require BSL-3 biosafety level in case of a pandemic.
The whole of the manufacturing environment as well as the applied manufacturing processes are continuously controlled. They involve the qualification, calibration, and the regular maintenance of all the supply systems, equipment, and device as well as the validation of all the technological process. The manufacturing steps, the related process parameters, and the environmental conditions are monitored by a validated Building Management (BMS) system.
RESEARCH AND DEVELOPMENT
The Fluart Innovative Vaccines considers it of high importance to continuously develop its manufacturing environment so that it meets the challenges of a possible influenza epidemic under all circumstances.
As a result of our continuous R&D activity, we are prepared for both H5N1 and H1N1 pandemic threats well before their outbreak. Also, we can quickly and effectively respond to any future pandemic situation.
A further R&D achievement is that the currently available 3Fluart vaccine is effective with an active substance content of 6µgHA/0.5ml instead of the formerly applied 15µgHA/0.5ml.
