Abstract: The present invention relates to a method for purifying a recombinant follicle stimulating hormone (FSH) or recombinant FSH variant. The method comprises the steps of subjecting a liquid containing a recombinant FSH or recombinant FSH variant to an anion exchange chromatography, to a hydrophobic interaction chromatography, and to a dye affinity chromatography, wherein these chromatographies may be performed in any order, and wherein the method neither comprises a weak anion exchange chromatography nor a reverse phase chromatography. The method of purification results in a high yield of recombinant FSH having a desired degree of purity. The obtained FSH is especially useful for the prophylaxis and treatment of disorders and medical indications where FSH preparations are considered as useful remedies.

Abstract: The present invention relates to a method for the production and purification of a sialyltransferase polypeptide, in particular a N-Acetylgalactosamine (Gal NAc)-?-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.

Abstract: The present invention relates to a method for purifying a recombinant follicle stimulating hormone (FSH) or recombinant FSH variant. The method comprises the steps of subjecting a liquid containing a recombinant FSH or recombinant FSH variant to an anion exchange chromatography, to a hydrophobic interaction chromatography, and to a dye affinity chromatography, wherein these chromatographies may be performed in any order, and wherein the method neither comprises a weak anion exchange chromatography nor a reverse phase chromatography. The method of purification results in a high yield of recombinant FSH having a desired degree of purity. The obtained FSH is especially useful for the prophylaxis and treatment of disorders and medical indications where FSH preparations are considered as useful remedies.

Abstract: The present invention relates to a method for purifying a recombinant follicle stimulating hormone (FSH) or recombinant FSH variant. The method comprises the steps of subjecting a liquid containing a recombinant FSH or recombinant FSH variant to an anion exchange chromatography, to a hydrophobic interaction chromatography, and to a dye affinity chromatography, wherein these chromatographies may be performed in any order, and wherein the method neither comprises a weak anion exchange chromatography nor a reverse phase chromatography. The method of purification results in a high yield of recombinant FSH having a desired degree of purity. The obtained FSH is especially useful for the prophylaxis and treatment of disorders and medical indications where FSH preparations are considered as useful remedies.

Abstract: 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.

Abstract: The present invention relates to a method for the production and purification of a sialyltransferase polypeptide, in particular a N-Acetylgalactosamine (Gal NAc)-?-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.

Abstract: 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.

Abstract: 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.

Abstract: A method for the production of human glycosylated Interferon-beta (IFN-?) is described, comprising two affinity chromatography steps followed by hydrophobic interaction chromatography step preferably with a subsequent anion exchange chromatography step. IFN-? obtained by the method as described is characterized by a high purity and specific biologically activity, because of which it is particularly suitable for the production of pharmaceutical compositions.

Abstract: 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.

Abstract: The present invention relates to a method for purifying a recombinant follicle stimulating hormone (FSH) or re-combinant FSH variant. The method comprises the steps of subjecting a liquid containing a recombinant FSH or recombinant FSH variant to an anion exchange chromatography, to a hydrophobic interaction chromatography, and to a dye affinity chromatography, wherein these chromatographies may be performed in any order, and wherein the method neither comprises a weak anion exchange chromatography nor a reverse phase chromatography. The method of purification results in a high yield of recombinant FSH having a desired degree of purity. The obtained FSH is especially useful for the prophylaxis and treatment of disorders and medical indications where FSH preparations are considered as useful remedies.

Abstract: 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.

Abstract: 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.