Abstract: Antibody formulations and methods useful for prophylaxis or treatment of amyloidosis, including AA amyloidosis and AL amyloidosis.

Abstract: The invention provides anti-MCAM antibodies that inhibit the ability of human MCAM to bind a laminin alpha-4 chain. The invention also provides pharmaceutical compositions and pharmaceutical formulations, methods of generating such antibodies, and their use in the manufacture of medicaments for treatment of neuroinflammatory disease, autoimmune disease, or cancer.

Abstract: Antibody formulations and methods useful for prophylaxis or treatment of amyloidosis, including AA amyloidosis and AL amyloidosis.

Abstract: The invention provides antibody formulations and methods useful for prophylaxis or treatment of synucleinopathies, including Parkinson's disease.

Abstract: The invention concerns the field of biomolecule formulation screening and stability testing. It concerns a method for the evaluation of the colloidal stability of liquid biopolymer solutions. The present invention describes a method for determining the stability of a liquid pharmaceutical composition comprising: a) providing a liquid pharmaceutical composition in a container, b) shaking said container on a shaker, whereby the shaker performs an oloid movement, c) determining the stability of said liquid pharmaceutical composition.

Abstract: Antibody formulations and methods useful for prophylaxis or treatment of amyloidosis, including AA amyloidosis and AL amyloidosis.

Abstract: The present invention relates to anti-IL-23p19 binding compounds, in particular new humanized anti-IL-23p19 antibodies, pharmaceutical compositions and therapeutic and diagnostic methods and compositions for using the same.

Abstract: Antibody formulations and methods useful for prophylaxis or treatment of amyloidosis, including AA amyloidosis and AL amyloidosis.

Abstract: Provided herein, in one aspect, are antibodies that immunospecifically bind to PSGL-1, polynucleotides comprising nucleotide sequences encoding such antibodies, and expression vectors and host cells for producing such antibodies. Also provided herein are kits and pharmaceutical compositions comprising antibodies that specifically bind to PSGL-1, as well as methods of treating a disorder or disease caused by or associated with increased proliferation and/or numbers of activated T cells using the antibodies described herein.

Abstract: Provided herein, in one aspect, are antibodies that immunospecifically bind to PSGL-1, polynucleotides comprising nucleotide sequences encoding such antibodies, and expression vectors and host cells for producing such antibodies. Also provided herein are kits and pharmaceutical compositions comprising antibodies that specifically bind to PSGL-1, as well as methods of treating a disorder or disease caused by or associated with increased proliferation and/or numbers of activated T cells using the antibodies described herein.

Abstract: The invention relates to a method for preparing highly concentrated liquid protein formulations. They are prepared by concentrating a protein solution by carrier gas drying at a reduced process pressure.

Abstract: Provided herein, in one aspect, are antibodies that immunospecifically bind to PSGL-1, polynucleotides comprising nucleotide sequences encoding such antibodies, and expression vectors and host cells for producing such antibodies. Also provided herein are kits and pharmaceutical compositions comprising antibodies that specifically bind to PSGL-1, as well as methods of treating a disorder or disease caused by or associated with increased proliferation and/or numbers of activated T cells using the antibodies described herein.

Abstract: The invention therefore relates to protein-containing powders, wherein the proportion of phenylalanine is at least 30% (w/w), or at least 40% (w/w). It has been shown that phenylalanine-containing powders, particularly after spray drying, are very suitable in terms of their aerodynamic characteristics and protein stabilization for preparing powders or protein compositions with improved aerodynamic properties. The main component is phenylalanine and the optional further component is an excipient which has good water-solubility compared with phenylalanine, preferably a sugar or a polyol.

Abstract: Double chamber container for holding and combining, e.g., a lyophilizate and a liquid reconstitution medium, comprising an integral cylindrical body (15) with a closure (20, 60) at each of the two ends (5, 70), an upper movable closure (60) to the side of the reconstitution medium and a lower closure (20) to the side of the lyophilizate, a separating stopper (40) that can be moved in the cylindrical body (15) as a seal between the upper chamber (50) and the lower chamber (30), a bypass (35), arranged below the separating stopper (40), having a length L greater than the height H of the separating stopper (40), wherein at the lower end (5) in the wall of the cylindrical body (15) or in the lower stopper (20) there are provided means (21, 25, 28) that allow connection of the interior of the cylindrical body (15) to the environment during the lyophilization.

Abstract: A double chamber container for holding and combining a solid lyophilizate and a liquid reconstituting medium, comprising a cylindrical body with a closure at each of the two ends, an upper displaceable closure at the reconstituting medium end, and a lower closure at the lyophilizate end, a separating stopper that can be pushed in the cylindrical body and act as a seal between the upper chamber and the lower chamber, and a bypass arranged underneath the separating stopper, with a length L that is preferably greater than the height H of the separating stopper, wherein at the upper end in the wall of the cylindrical body or in the separating stopper means are provided that allow partial connection of the interior of the cylindrical body to the environment during the lyophilization.

Abstract: The present invention relates to an apparatus for determining the shear sensitivity of particles in solutions and methods of determining the respective shear velocities or the respective shear stress.

Abstract: The invention relates to a method for preparing powder mixtures, one component consisting of spray-dried powder. The invention also relates to a method for coating spray-dried particles with nanoscale particles, a method for mixing spray-dried powder with microscale particles and a method for covering carrier substances with spray-dried particles.

Abstract: The present invention concerns powders containing a pharmaceutical active substance and a combination of excipients comprising at least one 1,4 O-linked saccharose derivative selected from the compounds: 1,4 O-linked D-Gal-saccharose (lactosucrose), 1,4 O-linked D-Glu-saccharose (glucosyl sucrose), or 1,4 O-linked Glu-Glu-saccharose (maltosyl sucrose) in combination with at least one further excipient. The other excipient is preferably an amino acid, a peptide and/or a mono-, di- and/or oligosaccharide, wherein the oligosaccharide may be a second 1,4 O-linked saccharose derivative, provided that this is different from the first.

Abstract: The present invention relates to a spray-dried powder and method for its manufacture. A spray dried powder containing a pharmaceutical active substance and one or more 1,4 O-linked saccharose derivatives chosen from the compounds: 1,4 O-linked D-gal-saccharose (lactosucrose), 1,4 O-linked D-glu-saccharose (glucosyl sucrose) or 1,4 O-linked glu-glu-saccharose (maltosyl sucrose). Preferred combinations are such that they contain glucosyl and maltosyl sucrose.

Abstract: Disclosed are applications of oligosaccharides/oligosaccharide mixtures for the production and stabilization of pharmaceutical compositions, chiefly powders, that contain antibodies or antibody derivatives as pharmaceutical active substance. The production of powders is accomplished through spray drying or freeze drying. Also disclosed are the corresponding antibody-containing powders as well as processes for their production.