Abstract: The present invention relates to a composition comprising factor VII or a factor VII-related polypeptide, and factor V or a factor V-related polypeptide, and the use thereof for treating bleeding episodes.
Abstract: The invention provides a method for large-scale production of a polypeptide, such as a Factor VII or Factor VIIa polypeptide, in eukaryote cells, such as mammalian cells, contained in a culture liquid, said method comprising: monitoring the concentration of dissolved CO2 in the culture liquid, and constantly or intermittently sparging atmospheric air through the culture liquid, wherein the sparging rate of the air is controlled in relation to the monitored concentration of dissolved CO2 in the culture liquid. The method reduces or eliminates the use of bases while providing an excellent pH control. The invention also provides a culture vessel suitable for the methods.
Abstract: The invention concerns a pharmaceutical preparation comprising a factor VII or factor VII-related polypeptide and a factor IX or factor IX-related polypeptide. The invention also concerns use of a factor VII or factor VII-related polypeptide and a factor IX or factor IX-related polypeptide for manufacture of a medicament for pharmaceutical use as well as methods for prevention or treatment of bleeding episodes in subjects.
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.
Type:
Application
Filed:
March 3, 2006
Publication date:
September 14, 2006
Applicant:
Novo Nordisk HealthCare A/G
Inventors:
Henrik Ostergaard, Soren Bjorn, Egon Persson
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.
Type:
Application
Filed:
February 14, 2006
Publication date:
September 14, 2006
Applicant:
Novo Nordisk HealthCare A/G
Inventors:
Michael Jensen, Anders Petersen, Andrew Bowler
Abstract: This invention relates to novel compounds, methods for selective chemical conjugation of protractor molecules and the use thereof for diagnostic and/or therapeutic purposes.
Abstract: The invention provides a method for production of polypeptides in eukaryote microcarrier cell culture, the method comprising the steps of (i) Culturing cells expressing said polypeptide on microcarriers under conditions and at a setpoint temperature appropriate for expression of said polypeptide; (ii) Cooling the culture to a predetermined temperature below said setpoint; (iii) Sedimenting the microcarriers; and (iv) Harvesting all or part of the culture medium.
Abstract: The invention concerns a liquid aqueous composition comprising (i) a factor VII polypeptide, (ii) an agent suitable for keeping pH in the range of from about 4.0 to about 9.0; (iii) an agent selected from the group consisting of: a calcium salt, a magnesium salt, or a mixture thereof; wherein the concentration of (iii) is less than 15 mM; and (iv) An ionic strength modifying agent; wherein the ionic strength of the composition is at least 200 mM.
Type:
Application
Filed:
December 15, 2005
Publication date:
August 17, 2006
Applicant:
Novo Nordisk HealthCare A/G
Inventors:
Birthe Hansen, Michael Jensen, Troels Kornfelt
Abstract: The present invention is directed to liquid, aqueous pharmaceutical compositions 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, e.g., bleeding disorders, including those caused by clotting Factor deficiencies (e.g. haemophilia A, haemophilia B, coagulation Factor VII deficiency); by thrombocytopenia or von Willebrand's disease, or by clotting Factor inhibitors, and intra cerebral haemorrhage, or excessive bleeding from any cause. The preparations may also be administered to patients in association with surgery or other trauma or to patients receiving anticoagulant therapy. More particularly, the invention relates to liquid compositions stabilised against chemical and/or physical degradation.
Type:
Application
Filed:
December 15, 2005
Publication date:
July 27, 2006
Applicant:
Novo Nordisk HealthCare A/G
Inventors:
Michael Jensen, Birthe Hansen, Troels Kornfelt, Kirsten Jakobsen
Abstract: The present invention relates to a composition comprising factor VII or a factor VII-related polypeptide and alpha2-antiplasmin or an alpha2-antiplasmin-related polypeptide, and the use thereof for treating bleeding episodes.
Abstract: The present invention relates to novel human coagulation Factor VIIa variants having coagulant activity as well as polynucleotide constructs encoding such variants, vectors and host cells comprising and expressing the polynucleotide, pharmaceutical compositions, uses and methods of treatment.
Abstract: The present invention relates to novel human coagulation Factor VIIa variants having coagulant activity as well as nucleic acid constructs encoding such variants, vectors and host cells comprising and expressing the nucleic acid, pharmaceutical compositions, uses and methods of treatment.
Abstract: The invention relates to a liquid, aqueous pharmaceutical composition comprising a Factor VII polypeptide (e.g. human Factor VIIa) and a buffering agent; wherein the molar ratio of non-complexed calcium ions (Ca2+) to the Factor VII polypeptide is lower than 0.5. The composition may further comprise a stabilizing agent (e.g. copper or magnesium ions, benzamidine, or guanidine), a non-ionic surfactant, a tonicity modifying agent, an antioxidant and a preservative. The composition is useful for treating a Factor VII-responsive syndrome, such as bleeding disorders, including those caused by clotting Factor deficiencies (e.g. haemophilia A, haemophilia B, coagulation Factor XI deficiency, coagulation Factor VII deficiency); by thrombocytopenia or von Willebrand's disease, or by clotting Factor inhibitors, and intra cerebral haemorrhage, or excessive bleeding from any cause.
Type:
Application
Filed:
September 15, 2005
Publication date:
March 23, 2006
Applicant:
Novo Nordisk HealthCare A/G
Inventors:
Michael Jensen, Birthe Hansen, Troels Kornfelt, Kirsten Jakobsen, Janus Krarup, Egon Persson, Anders Petersen, Andrew Bowler
Abstract: The present invention relates to a composition comprising factor VII or a factor VII-related polypeptide, and PAI-1 or a PAI-1-related polypeptide, and the use thereof for treating bleeding episodes.
Abstract: The present invention relates to a composition comprising factor VII or a factor VII-related polypeptide and a protein C inhibitor, and the use thereof for treating bleeding episodes.
Abstract: The present invention relates to compositions comprising factor VII or a factor VII-related polypeptide and tranexamic acid, and the use thereof for treating bleeding episodes.
Abstract: The present invention relates to a composition comprising factor VII or a factor VII-related polypeptide and a tPA inhibitor, and the use thereof for treating bleeding episodes.