Drug – bio-affecting and body treating compositions – Enzyme or coenzyme containing – Hydrolases
Reexamination Certificate
2002-01-17
2004-08-24
Priebe, Scott D. (Department: 1632)
Drug, bio-affecting and body treating compositions
Enzyme or coenzyme containing
Hydrolases
C424S443000, C424S444000, C424S484000, C514S002600, C514S053000, C530S381000, C530S382000, C530S383000
Reexamination Certificate
active
06780411
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to recombinant human fibrin sealant (rhFS), which comprises recombinant human fibrinogen (rhFbgn), recombinant human thrombin (rhThrombin) and optionally recombinant human FXIII.
Fibrin sealant (FS) is a mixture of three protein components: Fibrinogen (Fbgn), Thrombin, and Factor XIII (FXIII). Fbgn forms the structural matrix of the sealant and is present in the largest concentration. Thrombin and FXIII are enzymes, and are present in much lower concentrations. Existing FS are prepared using Fbgn purified from human blood, and thrombin purified from either bovine or human sources. The Fbgn for commercial FS is derived from pooled plasma, but Fbgn for FS is also purified from single-donor and autologous sources by many blood banks. Regardless of the source of the components, FS are typically formulated as two solutions: Fbgn+FXIII, and Thrombin+CaCl
2
. When mixed, the thrombin converts Fbgn to fibrin (Fbn), and polymerises to form a gel. Thrombin also converts the zymogen (inactive) form of FXIII to the active form that, in the presence of calcium, covalently cross-links the polymerised Fbn molecules to strengthen the gel and modify its physical properties (FIG.
1
). When Fbgn is purified from human plasma, the FXIII is normally co-purified as a contaminant of the Fbgn. (FS prepared from blood-derived Fbgn may also contain other proteins, such as fibronectin (FN) and growth factors, as contaminants.)
DETAILED DESCRIPTION OF THE INVENTION
The present invention provides a totally recombinant Fibrin Sealant (rhFS), which comprises recombinant human Fbgn (rhFbgn), recombinant human thrombin (rhThrombin) and optionally recombinant human FXIII (rhFXIII) (zymogen or active). Recombinant human fibrin sealant (rhFS) is an alternative to existing fibrin sealants (FS) derived from non-recombinant components.
REFERENCES:
patent: 6117425 (2000-09-01), MacPhee et al.
patent: WO 93/05067 (1993-03-01), None
patent: WO 96/4025 (1996-07-01), None
Lewis et al., “The use of recombinant human fibrinogen, thrombin, and factor XIII to make a fully functional fibrin sealant,” Circulation 96 (8): I-352, Nov. 1997.*
Prunkard et al., “Heterologous production of recombinant human fibrinogen, thrombin, and factor XIII as components of completely recombinant fibrin sealants,” Thrombosis and Haemostasis, Supp. [S], p. OC152, ,Jun. 1997.*
Prunkard et al., “High-level expression of recombinant human fibrinogen in the milk of transgenic mice,” Nature Biotechnology, 14: 867-871, Jul. 1996.
Bishop Paul D.
Brown Paul A.
Lasser Gerald W.
Lewis, Jr. Kenneth B.
Lunn Paul G.
Parker Gary E.
Priebe Scott D.
ZymoGenetics Inc.
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