Abstract: Compositions and methods for inducing immune tolerance to proteins and subsequence administration of the proteins are disclosed. Compositions comprise proteins complexed with liposomes comprising PS and PC, wherein at least part of the PS is present as lyso-PS.

Abstract: The invention encompasses formulations and methods for the production thereof that permit the delivery of concentrated protein solutions. The inventive methods can yield a lower viscosity liquid protein formulation or a higher concentration of therapeutic or nontherapeutic proteins in the liquid formulation, as compared to traditional protein solutions. The inventive methods can also yield a higher stability of a liquid protein formulation.

Abstract: Described herein are dry vaccine compositions and methods of freezing aluminum-containing vaccines such that when converted into a dried powder, the dry vaccine can be readily reconstituted to form a stable liquid vaccine without significant loss of activity.

Abstract: The present disclosure provides pharmaceutical compositions for monoclonal antibodies, antibody-related products, therapeutic proteins, peptides and other biopharmaceuticals. The compositions provide initial and long term stability of the biopharmaceutical agent, rendering them suitable for parenteral, pulmonary, transdermal, topical, intradermal, intrascleral, intracorneal, ocular and other forms of delivery. The compositions and methods lead to higher yields in dilute solutions and reduce unwanted aggregation of the biopharmaceutical agent. The compositions and methods also allow for disaggregation of previously aggregated proteins and protection from aggregation upon dilution. Additionally, provided are non-aggregating antibody reagents for analytical immunoassays including ELISA methods. The invention provides compositions and methods for topical, enteral, parenteral, pulmonary and other forms of delivery of biologically active substances.

Abstract: A stable aqueous pharmaceutical formulation comprising a therapeutically effective amount of aflibercept, wherein the formulation is free of organic co-solvent and/or free of buffer; methods for making such a formulation; and methods of using such a formulation.

Abstract: Pharmaceutical compositions containing anti-beta amyloid (A?) antibodies or AD-binding fragments thereof are provided. These pharmaceutical compositions find use in the treatment of abnormal accumulation or deposition of A? in the central nervous system, mild cognitive impairment, and AD-associated disorders such as Alzheimer's disease.

Abstract: The disclosure provides stable pharmaceutical compositions comprising an anti-CD79b immunoconjugate and a surfactant. The disclosure also provides methods for using such compositions for the treatment of cancer.

Abstract: The present invention provides a stable liquid formulation of an antibody in phosphate-amino acid based dual buffer system. The antibody formulated in phosphate-amino acid based dual buffer system imparts optimum stability to the antibody, at lower as well as higher concentrations. Further, the antibody formulated in phosphate-amino acid based buffer system has low viscosity and is suitable for therapeutic administration of high concentrations of antibody.

Abstract: Stable aqueous pharmaceutical formulations for therapeutic antibodies and methods of using such stable aqueous pharmaceutical formulations.

Abstract: The present invention relates to stable, high-concentration low-viscosity formulations of MASP-2 inhibitory antibodies, kits comprising the formulations and therapeutic methods using the formulations and kits for inhibiting the adverse effects of MASP-2 dependent complement activation.

Abstract: An objective of the present invention is to provide stable antibody-containing formulations which are suitable for subcutaneous administration and in which aggregation formation is suppressed during long-term storage. The present inventors discovered that a significant stabilization effect was achieved by using an acidic amino acid, aspartic acid or glutamic acid as a counter ion species in histidine buffer or tris(hydroxymethyl)aminomethane, specifically by using histidine-aspartate buffer or histidine-glutamate buffer, or tris(hydroxymethyl)aminomethane-aspartate or tris(hydroxymethyl)aminomethane-glutamate as a buffer. The present inventors also discovered that a significant stabilization effect was achieved by using an acidic amino acid, aspartic acid or glutamic acid, as a counter ion species to a basic amino acid such as arginine, specifically by using arginine-aspartate or arginine-glutamate.

Abstract: The subject invention provides a method of treating an individual afflicted with early stage Dupuytren's disease characterized by the presence of one or more nodules on the individual's hand which comprises injecting into each nodule a pharmaceutical composition comprising an amount of an antihuman TNFa antibody or fragment thereof effective to treat the individual, wherein the pharmaceutical composition is in the form of a liquid and between 0.1 ml and 0.6 ml of the composition is injected into each nodule. This invention also provides for a pre-filled syringe for carrying out the above-described method.

Abstract: There is provided, inter alia, an aqueous solution comprising (i) an antibody protein; and (ii) a antibody protein stabilizing mixture of arginine, methionine, and a C3 polyol.

Abstract: The present invention provides stable pharmaceutical formulations comprising a human antibody that specifically binds to human programmed death-1 protein (PD-1). In certain embodiments, the formulations contain, in addition to an anti-PD-1 antibody, a buffer, an amino acid, a non-ionic surfactant, and a sugar. The pharmaceutical formulations of the present invention exhibit a substantial degree of antibody stability upon stress and storage.

Abstract: The present invention provides pharmaceutical formulations comprising an antibody that specifically binds to human interleukin-33 (hIL-33). The formulations may contain, in addition to an anti-IL-33 antibody, a buffer, at least one amino acid, at least one sugar, or at least one non-ionic surfactant. The pharmaceutical formulations of the present invention exhibit a substantial degree of antibody stability after storage for several months and after being subjected to thermal and other physical stresses.

Abstract: The present invention relates to the formulation of adenoviral vectors in sorbitol containing compositions in combination with a further amorphous sugar, its formulation as well as a method for obtaining a dried composition.

Abstract: The present invention is directed to compositions and methods for stabilizing a protein without a surfactant. The present invention is further directed to compositions comprising a protein and at least one excipient selected from the group consisting of hindered amines, anionic aromatics, functionalized amino acids, oligopeptides, low molecular weight aliphatic polyacids, zwitterions, phospholipids, cyclodextrins, polyethylene glycols, gelatins, urea, ethanol, glycerin, dextran, xanthan gum, 2-(2-ethoxyethoxy)ethanol, hydroxypropyl cellulose, propylene glycol, a short-chain organic acid, deoxycholate, sodium nitrate, sodium sulfate, proline and lysine.

Abstract: The invention relates to a liquid pharmaceutical formulation comprising an antibody or antigen-binding fragment thereof, cyclodextrin and methionine. In addition, it relates to a method for reducing precipitation of an antibody or an antigen-binding fragment thereof in a liquid pharmaceutical formulation through addition of methionine and cyclodextrin. In particular, the liquid pharmaceutical formulations comprises an anti-sclerostin antibody, hydroxypropyl-gamma cyclodextrin and methionine and may be used in the treatment of a bone disorder associated with at least one of low bone formation, low bone mineral density, low bone mineral content, low bone mass, low bone quality and low bone strength, and especially for treating osteoporosis.

Abstract: The present invention provides a method for preparation of a lyophilized formulation of an anti-CD 20 antibody as well as to a lyophilized formulation of an anti-CD 20 antibody, comprising an anti-CD 20 antibody and having a residual moisture content in the range of 1% to 10%. The present invention also relates to the reconstituted formulation obtained by the method described herein, the use of said antibody formulation as a medicament, the use of the lyophilized formulation for the preparation of a medicament and a method of treating a patient.

Abstract: Described are low viscosity, hypotonic formulations containing one or more proteins, e.g., antibodies, at high concentration, uses of the formulations, and articles of manufacture. In particular, the formulations are useful and beneficial for the subcutaneous administration or delivery of a high concentration of a protein drug, such as an antibody, to a subject who is afflicted with a disease or condition that is treatable by the protein drug.