Biogenerix Ag

Ratiopharm Gmbh

Biotest Ag

Biogenerix Gmbh

Walter Hinderer

Heinz Lubenau

Stefan Arnold

Christian Scheckermann

Gerhard Jahn

Bodo Plachter

Hans-H Sonneborn

Rolf Vornhagen

Provided are pharmaceutical liquid formulations of G-CSF, which are stable over a long time period and substantially free of excipients, as well as ready-to-use syringes containing such formulations and corresponding kits.

Methods of preparing a liquid formulation of G-CSF

Method of treatment using stable liquid formulation of G-CSF

Provided is a method of obtaining biologically active recombinant human G-CSF from inclusion bodies, wherein the solubilization and refolding process can be performed at ambient temperature and the purification step comprises reversed phase chromatography (RP), in particular RP-HPLC. The G-CSF preparation so obtained is characterized by high purity and homogeneity.

Method for obtaining biologically active recombinant human G-CSF

Stable liquid formulations of G-CSF

The present invention relates to a liquid pharmaceutical composition comprising a granulocyte colony stimulating factor polypeptide conjugated with a polymer, the composition having a pH value in the range of 4.5 to 5.5. The composition further comprises a surfactant and optionally one or more other pharmaceutically acceptable excipients. Further, the composition of the invention is free from tartaric acid or salts thereof and from succinic acid and salts thereof as buffering agents and does not contain amino acids as stabilizer. The composition has a good storage stability and is especially useful for the prophylaxis and treatment of disorders and medical indications where granulocyte colony stimulating factor preparations are considered as useful remedies.

Liquid formulation of G-CSF conjugate

The present invention relates to a liquid pharmaceutical composition comprising a granulocyte colony stimulating factor polypeptide conjugated with a polymer. In various embodiments, the composition has a pH value in the range of 4.5 to 5.5. Exemplary compositions further comprise a surfactant and optionally one or more other pharmaceutically acceptable excipients. The invention provides, inter alia, formulations free from tartaric acid or salts thereof and/or from succinic acid and salts thereof as buffering agents. Exemplary formulations are essentially devoid of not amino acids as stabilizers. The composition has good storage stability and is especially useful for the prophylaxis and treatment of disorders and medical indications where granulocyte colony stimulating factor preparations are considered as useful remedies.

Diagnostically relevant polypeptides and fusion proteins comprising an amino acid sequence which originates from cytomegalovirus and corresponds to a region of the major DNA-binding protein or of the C-terminal region of the tegument protein pp150 fused with at least one further fragment from another antigenic protein of cytomegalovirus are disclosed. The major DNA-binding protein is encoded by the reading frame UL57. The poly-peptides and fusion proteins according to the invention can be used in an advantageous manner in diagnostic tests and methods for the detection of IgM antibodies against cytomegalovirus.

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Rodgau, Germany

Walter Hinderer