Abstract: The present invention relates in general to a stable, preferably liquid, pharmaceutical formulation comprising an antibody, a buffer, a surfactant, a stabilizer selected from the group consisting of sugars and sugar alcohols, and further optionally a chelator and/or oxygen-scavenger. Furthermore, the present invention relates to an article of manufacture comprising a container and a stable pharmaceutical formulation of the invention.

Abstract: The present invention discloses an immediate release tablet comprising at least a tablet core, wherein the tablet core comprises at most 20% brexpiprazole relative to the total of the tablet core, and at least one pharmaceutically acceptable excipient, wherein the tablet core is made by direct compression. Also disclosed are a batch of such immediate release tablets, and a process for preparing such immediate release tablets.

Abstract: The present invention relates to crystalline brexpiprazole having a particle size distribution (PSD) characterized by a d(90) of 30 ?m to 100 ?m, by a d(10) of at least 1.0 ?m, and by a d(4,3) of at least 15.0 ?m. The present invention also relates to a pharmaceutical composition comprising a crystalline brexpiprazole having a PSD characterized by a d(90) of 30 ?m to 100 ?m, by a d(10) of at least 1.0 ?m, and by a d(4,3) of at least 15.0 ?m, and to an aqueous suspension comprising said crystalline brexpiprazole. The present invention also relates to a composition comprising a crystalline brexpiprazole having a PSD characterized by a d(90) of 30 ?m to 100 ?m, by a d(10) of at least 1.0 ?m, and by a d(4,3) of at least 15.0 ?m, wherein said composition is essentially free from secondary particles of brexpiprazole.

Abstract: The present invention relates to the field of biotechnology, and in particular to the field of antibodies. Provided herein are novel methods for removing glycosylated antibody variants from an antibody preparation, an antibody preparation obtained by said method, and a pharmaceutical composition comprising the same.

Abstract: The present invention relates to a method for determining the disintegration time of a film-shaped pharmaceutical dosage form and a disintegration testing device for use in such a method.

Abstract: The present invention relates to a pharmaceutical composition comprising linagliptin or a pharmaceutically acceptable salt thereof as active ingredient, wherein the pharmaceutical composition does not comprise a binder and wherein the pharmaceutical composition is obtained by direct compression.

Abstract: The present invention discloses possibilities to make use of a substance or a material arranged to block, absorb and/or reflect UV exposure of a certain wavelength region to reduce or prevent UV-induced dimerization and optionally further UV-induced brexpiprazole impurities of brexpiprazole in a brexpiprazole dihydrate comprising pharmaceutical composition.

Abstract: The present invention discloses an immediate release tablet comprising at least a tablet core, wherein the tablet core comprises at most 20% brexpiprazole relative to the total of the tablet core, and at least one pharmaceutically acceptable excipient, wherein the tablet core is made by direct compression. Also disclosed are a batch of such immediate release tablets, and a process for preparing such immediate release tablets.

Abstract: The present invention relates to the field of biotechnology, and in particular to the field of antibodies. Provided herein are novel methods for removing glycosylated antibody variants from an antibody preparation, an antibody preparation obtained by said method, and a pharmaceutical composition comprising the same.

Abstract: The present invention belongs to the field of pharmaceutical industry and relates to a pharmaceutical composition comprising an intragranulate phase and an extragranulate phase, wherein the pharmaceutically active ingredient (API) 2-({6-[(3R)-3-aminopiperidin-1-yl]-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl}methyl)benzonitrile or a pharmaceutically acceptable salt thereof, is present in the intragranulate phase, wherein said intragranulate phase is free from microcrystalline cellulose. Further, the present invention relates to a process for preparing the same.

Abstract: The present invention relates to a brexpiprazole dihydrate crystalline form having a particle size distribution of d50 of at most 10 ?m and less than 5% w/w of brexpiprazole anhydrate. The present invention also relates to a process for preparing this brexpiprazole dihydrate crystalline form and to pharmaceutical compositions thereof. The present invention also relates to a process for determining the absence of brexpiprazole anhydrate in this brexpiprazole dihydrate crystalline form. This brexpiprazole dihydrate crystalline form is used for the preparation of pharmaceutical compositions having delayed release properties upon intramuscular injection.

Abstract: The present invention relates to a solid oral pharmaceutical composition comprising vortioxetine hydrobromide in a matrix formed from at least one polyethylene oxide and optionally one or more further matrix forming polymers.

Abstract: The present invention relates to orodispersible films comprising a plant extract and to film forming suspensions comprising a plant extract. Further, the present invention relates to processes for preparing the orodispersible films and the film forming suspensions.

Abstract: The present invention relates to a method or process of producing a glycoprotein that interacts with, or acts as an agonist to, the erythropoietin receptor (EpoR), which glycoprotein has modified efficacy, wherein the method or process comprises the heterologous expression of said glycoprotein in a suitable expression system, and wherein at least one step is provided that results in a reduced acetylation rate of sialic acid residues in the glycoprotein (FIG. 16).

Abstract: The present invention relates to a brexpiprazole dihydrate crystalline form having a particle size distribution of d50 of at most 10 ?m and less than 5% w/w of brexpiprazole anhydrate. The present invention also relates to a process for preparing this brexpiprazole dihydrate crystalline form and to pharmaceutical compositions thereof. The present invention also relates to a process for determining the absence of brexpiprazole anhydrate in this brexpiprazole dihydrate crystalline form. This brexpiprazole dihydrate crystalline form is used for the preparation of pharmaceutical compositions having delayed release properties upon intramuscular injection.

Abstract: The present invention relates to a method for analysing protein variants of a recombinant protein of interest, such as antibodies or Fc-fusion proteins, in a liquid sample of a mammal. Specifically the method comprises a step of affinity purifying the recombinant protein of interest from the sample together with an internal standard, and analyzing the protein variants using an analytic separating method such as HPLC, capillary electrophoresis or MS. This method is particularly suited to measure pharmacokinetic parameters of a recombinant protein of interest, such as a biopharmaceutical, in a mammal in clinical or pre-clinical studies. It allows for the use of a small sample volume and the possibility to operate with high throughput, such as in a 96-well plate sample preparation. It also provides high sensitivity and allows analysis of protein variants individually.

Abstract: The present invention relates to a method of producing syringes. Said method comprises fixing a needle to a syringe body by use of an adhesive followed by subjecting the syringes thus obtained to heat treatment. The invention further relates to a method of reducing leachables and/or extractables in prefilled syringes, said method comprising heat treating pre-fabricated syringes at a temperature of at least 40° C. before filling.

Abstract: The invention is concerned with a transdermal therapeutic system (TTS) comprising buprenorphine and a method of manufacturing such a TTS. The transdermal therapeutic system is used for the transdermal administration of buprenorphine and analogues thereof. In particular, the invention relates to the use of a transdermal therapeutic system (TTS) for analgesic purposes. The TTS according to the invention comprises a transdermal drug delivery composition comprising buprenorphine and an adhesive component, which is a mixture of a crosslinked and a non-crosslinked acrylic polymer and a penetration enhancer comprising a keto acid.

Abstract: The present invention relates to a pharmaceutical composition comprising amorphous vortioxetine hydrobromide, a process for the preparation thereof, use thereof and a method for stabilizing said pharmaceutical composition.

Abstract: The invention relates to a pharmaceutical film formulation comprising one or more bitter-tasting drug(s) or pharmaceutically acceptable salts thereof, one or more film formers, a bitterness masker containing one or more inorganic and/or organic salt(s) and at least two monocyclic monoterpenes, and one or more sweetening agents.