Novo Nordisk Healthcare Ag

Novo Nordisk A/s

Troels Kornfelt

Michael Bech Jensen

Birthe Lykkegaard Hansen

Niels Kristian Klausen

Henrik Rasmussen

Kirsten Kramer Jakobsen

Lars Lindgaard Hansen

Flemming Steen Jensen

Hanne Nedergaard

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.

Stabilised solid compositions of factor VII polypeptides

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.

Stabilised compositions of factor VII polypeptides

Provided are storage containers for proteinaceous pharmaceutical compositions which are characterized in, among other things, comprising (i) a wall portion, wherein an inner wall material thereof is selected from silica-coated glass, silicone-coated glass, polymers of non-cyclic olefins, cycloolefin polymers and cycloolefin/linear olefin copolymers and (ii) one or more closure portions not constituting part of the wall portion, and which contains a formulation of a protein. Also provided are new methods of storing proteinaceous compositions. In one aspect, the stored protein is characterized as having an amino-terminal &#x3b3;-carboxyglutamic acid (Gla) domain with 9-12 Gla residues.

Protein stabilization in solution

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 8.0; (iii) an agent selected from the list of: a calcium salt, a magnesium salt, or a mixture thereof; wherein the concentration of (iii) is at least 15 mM is described.

Liquid composition of factor VII polypeptides

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 8.0; (iii) an agent selected from the list of: a calcium salt, a magnesium salt, or a mixture thereof; wherein the concentration of (iii) is at least 15 mM.

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.

The present invention relates to a pharmaceutical preparation comprising glucagon and a stabilizing amount of a pharmaceutically acceptable ampholyte, especially an amino acid or dipeptide or a mixture thereof and optionally an excipient. The preparation is stable for extended periods of time in solution at room temperature.

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Virum, Denmark

Troels Kornfelt