Biochemical characterization, stability, and pathogen safety of a new fibrinogen concentrate (fibryga®).
Biologicals
; 52: 72-77, 2018 Mar.
Article
en En
| MEDLINE
| ID: mdl-29336864
ABSTRACT
Fibryga® is a new lyophilized fibrinogen concentrate for intravenous use for the treatment of congenital fibrinogen deficiency. fibryga® is produced from pooled human plasma and the final product is characterized by high purity, integrity, and pathogen safety. Functional activity of fibrinogen was demonstrated by cross-linking studies and thromboelastometry; integrity of the fibrinogen molecule was demonstrated by size exclusion chromatography and the detection of only trace amounts of activation markers in the final product. Pathogen safety of fibryga® was proved by downscaling studies for the two dedicated pathogen inactivation/removal steps, i.e. solvent detergent treatment and nanofiltration. Fibryga® is stable for at least three years when stored at room temperature. In conclusion, the performed studies demonstrated that fibryga® meets the requirements for a state-of-the-art fibrinogen concentrate, such as a satisfactory activity profile combined with a favorable pathogen safety profile and stability.
Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Fibrinógeno
/
Desinfección
Límite:
Humans
Idioma:
En
Año:
2018
Tipo del documento:
Article