Abstract: The present invention relates to crystalline valbenazine ditosylate, in particular to a crystalline hydrate of valbenazine ditosylate and a crystalline anhydrate of valbenazine ditosylate, and to methods for their preparation. Furthermore, the invention relates to a pharmaceutical composition comprising the crystalline hydrate or the crystalline anhydrate, preferably in an effective and/or predetermined amount and to the use of said pharmaceutical composition as a medicament, in particular for the treatment of hyperkinetic movement disorders such as tardive dyskinesia.

Abstract: The present invention relates in general to a nucleic acid encoding human granulocyte-colony stimulating factor (G-CSF), wherein the first leucine residue occurring on the N-terminal end of the encoded G-CSF is encoded by a codon other than the CTG/CUG codon, and wherein the nucleic acid does neither comprise the nucleic acid sequence according to SEQ ID NO: 1, nor according to SEQ ID NO: 2, nor according to SEQ ID NO: 3, nor according to SEQ ID NO: 4. The present invention also relates to a nucleic acid 100% complementary to the aforementioned nucleic acid, as well as to vectors and host cells comprising the aforementioned nucleic acids. Finally, the present invention relates to methods for producing human G-CSF using these nucleic acids, vectors and/or host cells and resulting G-CSF compositions.

Abstract: The present invention relates to a solid dispersion comprising amorphous brigatinib and methods for preparing the same. The invention also concerns a pharmaceutical composition comprising an effective amount of said solid dispersion and at least one further pharmaceutically acceptable excipient as well as methods for its preparation. The pharmaceutical composition of the present invention may be used as a medicine in particular for the treatment of ALK (anaplastic lymphoma kinase)-positive metastatic non-small cell lung cancer (NSCLC) and other diseases.

Abstract: The invention relates to a process for the preparation of avibactam sodium in polymorphic form C comprising the steps (i) providing a mixture comprising avibactam or a salt thereof and a solvent, wherein the mixture has a water content of less than 2% by weight based on the weight of the mixture; (ii) increasing the temperature of the mixture provided in (i) to at least 55° C. and providing a positive pressure; adding a sodium source to the mixture in step (i) and/or (ii) if the form of avibactam provided in (i) is not avibactam sodium; thereby obtaining avibactam sodium in polymorphic form C.

Abstract: The present invention relates to crystalline forms of cabotegravir sodium and to methods for their preparation. Furthermore, the invention relates to a pharmaceutical composition comprising one of said crystalline forms of cabotegravir sodium, preferably in a predetermined and/or effective amount, and at least one pharmaceutically acceptable excipient. The pharmaceutical composition of the present invention can be used as a medicament, in particular for the treatment and/or prophylaxis of viral infections such as HIV infections.

Abstract: The present invention relates to a pharmaceutical composition containing a stable polymorph of rifaximin and a wicking agent as well as a method of preparing the same.

Abstract: The invention relates to acid addition salts of ridinilazole and processes for the preparation of ridinilazole using these acid addition salts. In addition, the present invention relates to processes for the preparation of ridinilazole in pure form using acid addition salts of ridinilazole as process intermediates.

Abstract: The present invention deals with a method for detecting a protein in a protein sample by amplifying and enhancing small differences between proteins contained in the protein sample. In particular, the present invention uses a cascade of enzymatic modification steps to detect and identify a protein in a protein sample by enhancing small differences between the protein and other proteins contained in the protein sample. Further, the present invention provides a method for distinguishing two proteins having substantially identical or similar amino acid sequences but different protein conformations.

Abstract: A method for producing a protein of interest on a manufacturing scale is based on integration, by homologous recombination, of the DNA encoding the protein of interest into a bacterial cell's genome at a pre-selected site. The manufacturing scale production of recombinant proteins is in the fed-batch mode, semi-continuous or in a chemostat.

Abstract: The present invention relates to a co-crystal of roxadustat with L-proline and to a process for its preparation. Furthermore, the invention relates to a pharmaceutical composition comprising said roxadustat L-proline co-crystal, at least one pharmaceutically acceptable excipient and optionally at least one photostabilizing agent. The pharmaceutical composition of the present invention can be used as a medicament, in particular for the treatment and/or prevention of anemia in patients with end-stage renal disease (ESRD) and/or chronic kidney disease (CKD).

Abstract: The present invention relates to new promoter sequences and uses thereof, in particular expression cassettes, vectors, and methods of expressing genes using the new promoters.

Abstract: Amino acid residue misincorporations are necessarily found in sequence variants at low concentrations in admixture with expressed polypeptides, resulting from one or more base mismatches within codons susceptible to amino acid residue misincorporation during transcription and/or translation. The invention provides a method of optimizing the coding sequences of a polynucleotide that encodes a polypeptide, wherein at least one codon is susceptible to amino acid residue misincorporation. The method of the invention can be used to reverse-engineer an unknown coding sequence, which encodes the same polypeptide, but differs in said at least one codon from the known coding sequence. The method can further be used to alter the immunogenic potential of an expressed polypeptide. Thus, the invention is useful in engineering optimized polynucleotides encoding polypeptides.

Abstract: The present disclosure generally relates to crystalline valbenazine. The present disclosure also generally relates to a pharmaceutical composition comprising crystalline valbenazine, as well of methods of using crystalline valbenazine in the treatment of hyperkinetic disorders, and methods for obtaining such forms.

Abstract: The invention relates to crystalline eravacycline bis-hydrochloride and to a process for its preparation. Furthermore, the invention relates to the use of crystalline eravacycline bis-hydrochloride for the preparation of pharmaceutical compositions. The invention further relates to pharmaceutical compositions comprising an effective amount of crystalline eravacycline bis-hydrochloride. The pharmaceutical compositions of the present invention can be used as medicaments, in particular for treatment and/or prevention of bacterial infections e.g. caused by Gram negative pathogens or Gram positive pathogens, in particular caused by multidrug resistant Gram negative pathogens. The pharmaceutical compositions of the present invention can thus be used as medicaments for e.g.

Abstract: The present invention refers to pellets comprising pharmaceutically active ingredient and binder. Further, the invention refers to a process for preparing said pellets, to the use of said pellets for preparing a pharmaceutical composition, and to a dosage form comprising said pellets or pharmaceutical composition. Finally, the present invention refers to a dosage from for use in a method of treating a disease selected from the group consisting of gastro esophageal reflux disease, peptic ulcer disease, and Zollinger-Ellison syndrome and for prevention of upper gastrointestinal bleeding in people who are at high risk.

Abstract: The present invention provides novel methods of cell disruption and release of biomolecules from a cell. The invention comprises the use of positively and/or negatively charged microparticles comprising ground resin. It is particularly useful for purification of biomolecules from cell culture.

Abstract: The present invention relates to a polymorphic form of masitinib mesylate, processes for its preparation, pharmaceutical compositions comprising it and their medical use.

Abstract: The present invention relates to a pharmaceutical composition containing rifaximin in the form of two different polymorphs as well as a method of preparing the same.

Abstract: The present invention relates to crystalline valbenazine ditosylate, in particular to a crystalline hydrate of valbenazine ditosylate and a crystalline anhydrate of valbenazine ditosylate, and to methods for their preparation. Furthermore, the invention relates to a pharmaceutical composition comprising the crystalline hydrate or the crystalline anhydrate, preferably in an effective and/or predetermined amount and to the use of said pharmaceutical composition as a medicament, in particular for the treatment of hyperkinetic movement disorders such as tardive dyskinesia.

Abstract: The invention relates to an amorphous solid dispersion comprising elagolix sodium and at least one silicon-based inorganic compound and to a process for preparing the same. Furthermore, it relates to a pharmaceutical composition comprising said solid dispersion and one or more additional pharmaceutical acceptable excipient(s), wherein the pharmaceutical composition can be used as a medicament, in particular for the treatment of endometriosis and uterine fibroids.