About fibryga®

A highly pure fibrinogen concentrate.

It high specific activity of approximately 98% clottable protein, based on total protein, is almost identical to the theoretical value of 1.0, for a fully native fibrinogen. Additionally, it contains low levels of activation marker proteins and high molecular-weight proteins (HMWP)¹.

The consistent kinetic profile for y-y cross-linking indicates that fibryga^® is also a fully functional fibrinogen concentrate.¹

Reliable Pathogen Safety

fibryga® undergoes rigorous procedures to prevent any risk of infections as it is a product prepared from human blood. This includes the selection of donors, screening of individual donations and plasma pools for specific markers of infection, as well as the inclusion of effective manufacturing steps for the inactivation/removal of viruses.

These manufacturing steps include solvent/detergent treatment, which inactivates enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV), and nanofiltration (20 nm) for the removal of both enveloped viruses and non-enveloped viruses such as hepatitis A virus (HAV) and parvovirus B19. Nanofiltration also removes potentially present infectious prion proteins, such as those believed to be responsible for transmissible spongiform encephalopathy, CJD and the variant form of CJD.1,2