Biogenerix Ag

Biogenerix Gmbh

Ratiopharm Gmbh

Christian Scheckermann

Walter Hinderer

Stefan Arnold

Dietmar Eichinger

Axel Angermann

Karsten Schmidt

The present invention relates to a method for the production and purification of a sialyltransferase polypeptide, in particular a N-Acetylgalactosamine (Gal NAc)-&#x3b1;-2,6-sialyltransferase I (ST6GalNAcI) polypeptide. The method comprises the steps of producing the sialyltransferase polypeptide in a Chinese Hamster Ovary (CHO) cell and purifying the polypeptide with a combination of chromatography steps. The method results in high yield of sialyltransferase polypeptide which is highly pure and active. The obtained sialyltransferase, especially ST6GalNAcI, can be employed for the glycosylation of therapeutic proteins such as G-CSF.

Method of producing and purifying an active soluble sialyltransferase

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

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.

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Ehrenkirchen, Germany

Christian Scheckermann