Abstract: Abstract: The present invention belongs to the field of biotechnology, and specifically relates to recombinant gene expression. The invention concerns a method of recombinant gene expression from a Chinese Hamster Ovary (CHO) cell, by using super-enhancer sequences for increased gene expression. Thus, the invention provides a method for producing an engineered CHO cell by introducing into the cell an exogenous nucleic acid molecule into or within 500 kb upstream or downstream of a super-enhancer as expression-enhancing sequence. The invention further provides an engineered CHO cell produced by the method. The invention further provides a method of producing a recombinant polypeptide. The invention is further directed to the use of a super-enhancer for transgene expression.

Abstract: The present invention relates in general to the field of recombinant protein expression. In particular, the present invention relates to a method for selecting a suitable candidate cell clone for recombinant protein expression and to a host cell for recombinant protein expression, the host cell exhibiting artificially modified gene expression of at least one gene selected from the group consisting of: Fkbp10, ZdhhC6, Myrip, Actc1, AC124993.19, Runx2, AC158560.4, PlekhB1, Rps6KA2, Sept1, Sprr2k, and Flt1.

Abstract: The present invention relates in general to the field of recombinant protein expression. In particular, the present invention relates to a method for selecting a suitable candidate cell clone for recombinant protein expression and to a host cell for recombinant protein expression, the host cell exhibiting artificially modified gene expression of at least one gene selected from the group consisting of: Hist1h2bc, Egrl, BX842664.2/Hist 1h3c, Dhfr, Fgfr2, AC115880.11, Mmp10, Vsnll (optional), CU459186.17, El 30203 B14Rik, Cspg4, C1qtnf1, Foxp2, and Ptpre.

Abstract: The present invention belongs to the field of pharmaceutical industry and relates to a solid pharmaceutical composition comprising androgen receptor antagonists, e.g. Enzalutamide or ARN-509, as well as to processes for preparing the same. The solid pharmaceutical compositions are useful in the treatment of prostate cancer.

Abstract: A pharmaceutical composition having a pharmaceutically active ingredient (API) that is poorly soluble in water, the pharmaceutical composition obtained by a process, which generates a dosage form containing the pharmaceutical composition. Use of the generated dosage form for the treatment of hypercholesterolemia.

Abstract: The present invention relates to processes for preparing substances with antiviral activity, in particular the integrase inhibitors dolutegravir and cabotegravir and analogues thereof, as well as intermediates useful in the processes.

Abstract: The present invention relates to non-stoichiometric crystalline hydrates of 1-(?-D-glucopyranosyl)-4-methyl-3-[5-(4-fluorophenyl)-2-thienylmethyl]benzene, processes for their preparation, and their use as medicaments. In addition the present invention relates to pharmaceutical compositions comprising an effective amount of the novel crystalline hydrates.

Abstract: The present invention is related to a cell culture medium for reducing the C-terminal heterogeneity of a polypeptide expressed in cell-culture, wherein the medium comprises at least one essential trace element in an effective amount, and to a cell culture process for reducing C-terminal heterogeneity of a protein, in which process an essential trace element is used.

Abstract: The present invention relates to coated particles and pharmaceutical dosage forms comprising the active substances sensitive to environmental influences. The coating of the present invention provides stability and protection of the active substance to environmental influences and in particular from oxidation and/or environmental humidity by coating.

Abstract: The present invention relates to processes for preparing substances with antiviral activity, in particular the integrase inhibitors dolutegravir and cabotegravir and analogues thereof, as well as intermediates useful in the processes.

Abstract: The present invention relates in general to the field of recombinant protein expression. In particular, the present invention relates to a method for selecting a suitable candidate cell clone for recombinant protein expression and to a host cell for recombinant protein expression, the host cell exhibiting artificially modified gene expression of at least one gene selected from the group consisting of: Fkbp10, ZdhhC6, Myrip, Actc1, AC124993.19, Runx2, AC158560.4, PlekhB1, Rps6KA2, Sept1, Sprr2k, and Flt1.

Abstract: The present invention relates in general to the field of recombinant protein expression. In particular, the present invention relates to a method for selecting a suitable candidate cell clone for recombinant protein expression and to a host cell for recombinant protein expression, the host cell exhibiting artificially modified gene expression of at least one gene selected from the group consisting of: Hist1h2bc, Egrl, BX842664.2/Hist 1h3c, Dhfr, Fgfr2, AC115880.11, Mmp10, Vsnll (optional), CU459186.17, El 30203 B14Rik, Cspg4, C1qtnf1, Foxp2, and Ptpre.

Abstract: The present invention relates to a process for spray-freeze-drying (SFD) a dispersion of polyelectrolyte complex (PEC) nanoparticles loaded with a protein drug, which yields a powdered product with adequate flowability properties that may readily be processed further into solid dosage forms such as tablets or capsules. The mean particle size of PEC nanoparticles obtained after redispersion of SFD powder or pharmaceutical compositions made from said powder in water is preserved in the nanometer range (<1000 nm), and so is the protein biological activity.

Abstract: The present invention relates to 1-[2-(2,4-dimethylphenylsulfanyl)phenyl]piperazine acetate in crystalline form and to methods for the preparation thereof. In addition the present invention relates to solid pharmaceutical compositions for oral administration comprising an effective amount of the crystalline 1-[2-(2,4-dimethylphenylsulfanyl)phenyl]piperazine acetate. Moreover, the present invention relates to the use of crystalline 1-[2-(2,4-dimethylphenylsulfanyl)phenyl]piperazine acetate for the preparation of pharmaceutical compositions.

Abstract: The invention relates to novel hydrates of dolutegravir sodium and to processes for their preparation. Furthermore, the invention relates to a novel crystalline form of dolutegravir sodium, which is a useful intermediate for the preparation of one of the novel hydrates. In addition, the invention relates to the use of the novel hydrates for the production of pharmaceutical compositions. Finally, the invention relates to pharmaceutical compositions comprising an effective amount of the novel hydrates, to oral dosage forms comprising said pharmaceutical compositions, to a process for preparing said oral dosage forms, and to the use of said pharmaceutical compositions or dosage forms in the treatment of retroviral infections such as HIV-1 infections.

Abstract: A pharmaceutical composition comprising an ester of 4-(1-hydroxy-1-methylethyl)-2 propyl-1-[[2?-(1H-tetrazol-5-yl)[1,1?-biphenyl]-4-yl]methyl]-1H-imidazole-5-carboxylic acid characterized in that when exposed to 75% relative humidity at 40° in open dish for one month the total amount of related substances does not increase more than 1% is described.

Abstract: The present invention relates to processes for preparing ?-aminosulfone compounds. The provided compounds are useful intermediates in the preparation of sulfone group containing isoindoline-based compounds, in particular apremilast.

Abstract: The present invention is related to a method to reduce peptide amidation activity in a given cell line, cell lines with reduced peptide amidation activity, and uses thereof.

Abstract: A stable formulation of telmisartan and hydrochlorothiazide having both substances in separate units is prepared, exhibiting exceptional stability when subjecting to stress conditions.

Abstract: The present invention relates to a medium for the cultivation of eukaryotic cells, the medium comprising as (an) additive(s) DMSO, N-acetylmannosamine (NAcMan), N-acetylglucosamine (NAcGlc), or any combination of two or more of these additives, including the combination of NAcMan and NAcGlc.