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COMPATIBILITY AND STABILITY OF RECONSTITUTED FIBRINOGEN CONCENTRATE (CLOTTAFACT®/ FIBCLOT®) WITH CODAN INFUSION SET

Authors: Handke, N; Chevalier, H; Duvet, C; Huteau, L; Jabol, C; Kopp, A; Meunier, S; Pechard, C; Krier, C

Affiliations: LFB Biotechnol, Biopharmaceut Dev Dept, Les Ulis, France; LFB Biotechnol, Qual Dev Dept, Les Ulis, France; LFB Biomedicaments, Qual Control Labs, Lille, France

Publication: Haemophilia; 2025; 31. 58

ABSTRACT:

Background/Aims: ClOTTAFACT® / FibClOT'” is a lyophilised human fibrinogen concentrate (1.5 g) reconstituted in 100 ml solution for intravenous injection using an infusion set supplied by CODAN equipped with a 15 µm filter. Clinical practice often necessitates reconstitution with decreased praduct wastage, especially for massive haemorrhage pratocols. Extending the expiration date for reconstituted fibrinogen concentrate could minimise turnaraund times and reduce wastage. A compatibility study with the infusion set was conducted to ensure the stability of reconstituted fibrinogen up ta 48 hours.
Materials and Methods: Vials previously stored for a minimum of 36 months at +25°C and +30°C were reconstituted and infused at 1 ml/ min and at 20 ml/min flow rates using the CODAN line ta simulate long­duration infusion and shear stress, respectively. Visual inspections and analyses were performed immediately after reconstitution [TO), and at 24 hours [T24h) and 48 hours [T48h) post-reconstitution, compared with non­infused solutions as contrais.
Results: Parameters of visible and subvisible particles, osmolality, pH, total pratein, fibrinogen concentration, coagulable fibrinogen and specific activity remained stable at TO, T24, and T48 hours post-reconstitution acrass all conditions, with no significant differences between in-use and contrai vials.
Conclusions: The compatibility study demonstrated that after storage at + 25°C and +30°C for over 36 months, reconstituted ClOTTAFACT”‘ / FibClOT® infused using the CODAN line remains stable up ta 48 hours post-reconstitution under 1 ml/min and 20 ml/min flow rates, meeting all criteria [physico-chemical and biological activity quality attributes), thus demonstrating a trend of no praduct degradation.