A pasteurised concentrate of human plasma factor XIII for therapeutic use.
A therapeutic concentrate of factor XIII containing both A and B sub-units has been prepared from 300 kg pools of human plasma. The process starts from a cold-ethanol fraction from cryoprecipitate supernatant and therefore does not interfere with the recovery of other clinically valuable plasma proteins. Factor XIII is purified approximately 600-fold from plasma by precipitation with sodium citrate and by the removal of fibrinogen by brief heating. The product has been pasteurised in sorbitol solution to inactivate blood-borne viruses, ultrafiltered to remove sorbitol, adsorbed with bentonite and freeze-dried in a formulation meeting requirements for intravenous injection.
D004340:Drug Contamination; D005176:Factor XIII / Q000009:adverse effects / Q000302:isolation & purification* / Q000627:therapeutic use; D005177:Factor XIII Deficiency / Q000188:drug therapy; D005612:Freeze Drying; D006525:Hepatitis, Viral, Human / Q000517:prevention & control; D006801:Humans; D013012:Sorbitol; D013242:Sterilization
D013012:Sorbitol; D005176:Factor XIII