about plasma

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Rigorous standards

BPL employs a variety of virus inactivation and removal procedures for its products.

These procedures are chosen to ensure maximum virus inactivation or removal whilst retaining the biological function of the plasma proteins.

Virus filtration: A filter with a pore size of just 15 or 20 nm, removing both lipid-enveloped and non-enveloped viruses.  It is a relatively gentle method and allows high levels of protein recovery.

Copper affinity chromatography: Preferentially binds Factor IX leaving other material such as viruses to pass to waste.

CM-Sepharose chromatography: Preferentially binds positively charged IgGs, leaving other material such as viruses to pass to waste.

Pasteurisation: 60°C for 10 hours (solutions).

Solvent/detergent treatment: Inactivates lipid-enveloped viruses.

Terminal dry-heat treatment: 80°C for 72 hours (freeze-dried powder). Inactivates both lipid-enveloped and non-enveloped viruses.

Terminal low pH incubation: Incubated at 30°C for 2 weeks. A low pH formulation contributes to effective inactivation of lipid enveloped viruses.

Patient information leaflets