Abstract: The present invention relates to the use of a glass container having a contact angle of more than about 10° for preventing glass fogging during freeze drying of a pharmaceutical composition. The pharmaceutical composition comprises a therapeutic agent and a surfactant. The respective glass container and a method for freeze drying the pharmaceutical composition are also disclosed.

Abstract: The invention provides a method for reducing aggregation and inhibiting flocculation of a macromolecule, such as a protein, under physiological conditions, by the addition of 5% to 20% polyvinylpyrrolidone (PVP) with a molecular weight range of 2000 to 54,000 daltons. The invention further provides a method to minimize inflammation at the injection site during subcutaneous administration of a macromolecule. In further aspects, the invention provides pharmaceutical formulations for subcutaneous administration of a macromolecule, and methods of treating a CD20 positive cancer or an autoimmune disease, comprising administering a humanized anti-CD20 antibody in a pharmaceutical formulation of the invention. The invention further provides an in vitro dialysis method to evaluate the ability of an excipient to reduce aggregation of an antibody or other macromolecule under physiological conditions.

Abstract: The present invention relates to a method of ultra- and dialfiltrating an antibody solution containing at least one solute in addition to the antibody, which comprises diafiltrating the antibody solution with a solvent and bringing said mixture into contact with a semi-permeable membrane so as to allow the at least one solute present in the antibody solution and having a molecular weight lower than the molecular weight cut-off of the membrane to pass through the membrane, whilst retaining the antibody so that a modified antibody solution is obtained that only contains the antibody and the solvent.

Abstract: The invention relates to an aqueous pharmaceutical preparation comprising an antibody against endothelial growth factor receptor (EGF receptor). The preparation has increased storage stability, even at elevated temperatures, and can be used for the treatment of tumours.

Abstract: This invention relates to a pharmaceutical formulation of an antibody against Epidermal Growth Factor Receptor (EGFR), a process for the preparation and uses of the formulation.

Abstract: The present invention relates to a pharmaceutical composition, comprising an Insulin-like growth factor I (IGF-I) protein as active pharmaceutical ingredient (API), a tonicity agent and a buffer. This composition may be administered as injection or infusion and is especially useful for the treatment, prevention and/or delay of progression of neurodegenerative disorders, in particular Alzheimer's Disease (AD), a motor neuron disease (MND), in particular amyotrophic lateral sclerosis (ALS) or Spinal Muscular Atrophy (SMA) or a Muscular Dystrophy (MD), in particular Duchenne Muscular Dystrophy (DMD) or Myotonic Dystrophy (MMD).

Abstract: The invention relates to solid forms of antibodies against the EGF receptor, in particular precipitates and crystals of monoclonal antibodies against the EGF receptor, particularly preferably of Mab C225 (cetuximab) and Mab h425 (EMD 72000), which result in biologically active antibody protein through dissolution or suspension in aqueous medium, obtainable by precipitation of the antibody and/or one of its variants and/or fragments dissolved or suspended in aqueous medium by means of a precipitation reagent. The invention furthermore relates to pharmaceutical preparations comprising at least one solid form of above-mentioned antibodies in precipitated non-crystalline, precipitated crystalline or in soluble or suspended form, and optionally excipients and/or adjuvants and/or further pharmaceutical active ingredients, and to a process for the preparation of solid forms of anti-EGFR antibodies according to the invention.

Abstract: The present invention relates to a highly concentrated, stable pharmaceutical formulation of a pharmaceutically active anti-CD20 antibody, such as e.g. Rituximab, Ocrelizumab, or HuMab<CD20>, or a mixture of such antibody molecules for subcutaneous injection. In particular, the present invention relates to formulations comprising, in addition to a suitable amount of the anti-CD20 antibody, an effective amount of at least one hyaluronidase enzyme as a combined formulation or for use in form of a co-formulation. The said formulations comprise additionally at least one buffering agent, such as e.g. a histidine buffer, a stabilizer or a mixture of two or more stabilizers (e.g. a saccharide, such as e.g. ?,?-trehalose dihydrate or sucrose, and optionally methionine as a second stabilizer), a nonionic surfactant and an effective amount of at least one hyaluronidase enzyme. Methods for preparing such formulations and their uses thereof are also provided.

Abstract: The present invention relates to a stable pharmaceutical parenteral formulation of an antibody, antibody molecule, a mixture of antibodies and/or a mixture of antibody molecules against the amyloid-beta peptide (Abeta) and a process for the preparation. Furthermore, corresponding uses are described.

Abstract: The present invention relates to a highly concentrated, stable pharmaceutical formulation of a pharmaceutically active anti-HER2 antibody, such as e.g. Trastuzumab (HERCEPTIN™), Pertuzumab or T-DM1, or a mixture of such antibody molecules for subcutaneous injection. In particular, the present invention relates to formulations comprising, in addition to a suitable amount of the anti-HER2 antibody, an effective amount of at least one hyaluronidase enzyme as a combined formulation or for use in form of a co-formulation. The formulations comprise additionally at least one buffering agent, such as e.g. a histidine buffer, a stabilizer or a mixture of two or more stabilizers (e.g. a saccharide, such as e.g. ?,?-trehalose dihydrate or sucrose, and optionally methionine as a second stabilizer), a nonionic surfactant and an effective amount of at least one hyaluronidase enzyme. Methods for preparing such formulations and their uses thereof are also provided.

Abstract: The invention relates to a method for stabilizing an aqueous protein solution against exogenous stress and to the use of a container for stabilizing an aqueous protein solution.

Abstract: The present invention relates to an anti-IGF-1R human monoclonal antibody formulation, a process for the preparation of said formulation and uses thereof

Abstract: Pharmaceutical formulations of an antibody against OX40L and processes for making the same.

Abstract: This invention relates to a pharmaceutical formulation of an antibody against P-Selectin, a process for the preparation of the formulation and uses of the formulation.

Abstract: Pharmaceutical formulation of an antibody against IL-1R (interleukin-1 receptor), a process for the preparation and uses of the formulation.

Abstract: The present invention relates to a pharmaceutical formulation comprising an anti-CD20 antibody. The formulation may additionally comprise a buffer, a surfactant and/or an isotonicity agent.

Abstract: Pharmaceutical formulations of an antibody against IL13R?1 and processes for making the same.

Abstract: The invention relates to a method for stabilizing an aqueous protein solution against exogenous stress and to the use of a container for stabilizing an aqueous protein solution.

Abstract: The invention relates to a lyophilised pharmaceutical preparation comprising an antibody against the endothelial growth factor receptor (EGF receptor). The preparation has increased storage stability, even at elevated temperatures, and, after reconstitution, can be used parenterally for the treatment of tumours.

Abstract: The invention relates to a lyophilisate comprising N-diaminomethylene-2-methyl-4,5di(methylsulfonyl)benzamide as active compound. The composition has increased storage stability, even at elevated temperatures, and can be administered parenterally as medicament after reconstitution.