COAGADEX is manufactured from plasma obtained from healthy US donors who have passed viral screening tests
During the manufacturing process, COAGADEX undergoes 3 processing steps specifically designed to remove or inactivate viruses:
- Solvent/detergent treatment targeting enveloped viruses
- A virus filtration step designed to remove small viruses including non-enveloped viruses
- Terminal dry-heat treatment at 80°C for 72 hours in the final container to inactivate enveloped and non-enveloped viruses
*This 15 nm filtration step has also been tested by PCR using the human parvovirus B19 virus itself and confirmed to be effective, i.e. >5.9 log reduction.
BVD, bovine viral diarrhea virus, model for hepatitis C virus (HCV); CPV, canine parvovirus, model for human parvovirus B19; HAV, hepatitis A virus; HIV, human immunodeficiency virus; HSV, herpes simplex virus; IBR, infectious bovine rhinotracheitis, bovine herpesvirus model for enveloped DNA viruses including hepatitis B; NA, not applicable, solvent detergent step is limited to the inactivation of enveloped viruses; NT, not tested; SIN, Sindbis virus, model for HCV; WNV, West Nile Virus.
- Tests for prion protein reduction have reported an overall decrease of >9.2 log10: 2.5 log10 with metal chelate chromatography, >3.7 log10 with anion exchange chromatography, and 3.0 log10 for virus filtration
COAGADEX is made from human plasma and may contain infectious agents, e.g. viruses and, theoretically, the Creutzfeldt-Jakob disease agent.
Reference: COAGADEX® (Coagulation Factor X, Human) Prescribing Information. Durham, NC: BPL Limited. 2015.