Abstract: The present invention relates to Vitamin K-dependent protein compositions having a very low, or negligible, content of protein contaminants. The present invention also relates to method applicable in the preparation of such Vitamin K-dependent protein compositions. Such methods may either be used alone or in sequential combination with the purpose of reducing the relative content of protein contaminants. The present invention is particularly relevant in the preparation of compositions of coagulation factors selected from Factor X polypeptides (FX/FXa), Factor IX polypeptides (FIX/FIXa), Factor VII polypeptides (FVII/FVIIa), and the anticoagulant Protein C, in particular Factor VII polypeptides.

Abstract: The invention relates to a method of quality control testing a Factor XIII (FXIII) containing sample which comprises the step of detecting the presence of and/or measuring the concentration of pre-activated FXIII (FXIIIao) in said sample and to a quality control kit for determining the quality of a Factor XIII (FXIII) containing sample. Preferably, an anion-exchange chromatographic column is used, as well as the fluorescent substrate Abz-NE (Cad-Dnp) EQVS PLTLLK-OH.

Abstract: A mixing system (1) adapted to allow first contents of a first container (2) and second contents of a second container (3) to mix to form a material. The mixed material is retrieved to a syringe (20) without being foamed. The mixing system (1) comprises a transfer unit (5) which is adapted to receive the first container (2) at a first port (11), the second container (3) at a second port (12) and the syringe (20) at a third port (13). The transfer unit (5) further houses a number of fluid pathways (14, 15, 16) interconnecting the three ports (11, 12, 13) as well as a number of flow control members (17, 18, 19, 22) for controlling fluid flow between the containers (2, 3) and the syringe (20).

Abstract: The invention relates to chemically as well as physically stable kits and compositions comprising polypeptides, in particular Factor VII or Factor VII-related polypeptides, such that these compositions can be stored, handled and used at room temperature.

Abstract: The present invention relates generally to a novel method of introducing property modifying groups to a protein. In particular, the present invention relates to the derivatization of lysine residues, as well as new conjugates of growth hormones with improved pharmacological properties, and methods for their preparation and use in therapy.

Abstract: The present invention relates to a process for the purification of a protease.

Abstract: The invention relates to chemically as well as physically stable compositions comprising Factor VII or a Factor VII-related polypeptide such that these compositions can be stored, handled and used at room temperature.

Abstract: A device (1) for mixing substances to obtain an injectable medical product, the device (1) comprising a cartridge (50), a front piston (5), a front chamber (17) containing a liquid or a powder, a rear piston (6), a rear chamber (18) containing a liquid, a piston rod (7), and a bypass channel (19). The piston rod (7) is adapted to advance the rear piston (6) to collapse the rear chamber (18), whereby the liquid in the rear chamber (18) is forced to move to the front chamber (17) via the bypass channel (19). The piston rod (7) has a projection (10) which is adapted to mate with a recess (12) in the front piston (5) to provide an interlocking between the two components.

Abstract: The present invention relates to a novel method for improving the viral safety of liquid Factor VII compositions, in particular those comprising active Factor VII polypeptides (a Factor VIIa polypeptide).

Abstract: The present invention is directed to liquid, aqueous pharmaceutical compositions stabilised against chemical and/or physical degradation containing Factor VII polypeptides, and methods for preparing and using such compositions, as well as vials containing such compositions, and the use of such compositions in the treatment of a Factor VII-responsive syndrome. The main embodiment is represented by a liquid, aqueous pharmaceutical composition comprising at least 0.01 mg/mL of a Factor VII polypeptide (i); a buffering agent (ii) suitable for keeping pH in the range of from about 4.0 to about 9.0; and at least one stabilising agent (iii) comprising a —C(?N—Z1—R1)—NH—Z2—R2 motif, e.g. benzamidine compounds and guanidine compounds such as arginine.

Abstract: The present invention relates to a process for the purification of a protease.

Abstract: The present invention relates to novel covalent complexes of a Factor VII polypeptide and a Tissue Factor polypeptide, in particular to such complexes which are functionally active and which have an enhanced proteolytic activity towards Factor X compared to the corresponding free Factor VII polypeptide as well as methods for production of these novel complexes.

Abstract: The invention relates to a method for preventing or attenuating one or more complications of intracerebral haemorrhage (ICH), the method comprising: (i) selecting an ICH patient who exhibits one or more of the following characteristics: age?70, baseline ICH volume?60 mL, baseline IVH volume?5 mL, and elapsed time since onset of symptoms of less than about 2.5 hours; and (ii) administering to said patient in need thereof an effective amount of a first coagulation agent comprising Factor VIIa or a Factor VIIa equivalent.

Abstract: A drug storage and delivery device (1) comprising a reservoir (102) containing a liquid, a vial (101) containing a dry drug, such as a lyophilized drug, means (110) for forcing the liquid from the reservoir to the vial, via an established fluid connection, and valve means (106-108) to ensure a tight fluid connection between reservoir and vial can be established before the fluid paths are opened.

Abstract: The invention relates to a method for purifying a factor XIII polypeptide from a biological material, the method comprising subjecting the material to sequential chromatography on an anion-exchange matrix and a hydrophobic interaction matrix.

Abstract: The invention relates to the use of a Factor VIIa for the manufacture of a medicament for treatment of a condition affectable by Factor VIIa, said medicament being for subcutaneous, intramuscular or intradermal administration, and to the use of a Factor VIIa for the manufacture of a medicament for treatment of a condition affectable by Factor VIIa, wherein said medicament, when administered subcutaneously, intradermally or intramuscularly, shows a prolonged biological half-life.

Abstract: The present invention relates to novel coagulation Factor VII polypeptides, polynucleotide constructs encoding such polypeptides, as well as vectors and host cells comprising and expressing the polynucleotide, pharmaceutical compositions, uses and methods of treatment.

Abstract: The present invention encompasses isolated human coagulation Factor VII variants comprising a substitution of Phe in position 374 of SEQ ID NO 1 with another amino acid residue.

Abstract: A method for reducing or substantially preventing formation of a trisulfide derivative of a polypeptide in a liquid medium containing the polypeptide ijn question comprises stripping the liquid medium with a gas, suitably a chemically unreactive gas such as nitrogen or argon.

Abstract: The invention relates to the use of a Factor VIIa-related polypeptide for the manufacture of a medicament for treatment of a condition affectable by Factor VIIa, in particular a bleeding episode, said medicament being for subcataneous or intramuscular administration.