Abstract: The invention provides for mammalian cells capable of producing recombinant CTLA4-Ig and variants thereof. The invention also provides for compositions comprising CTLA4-Ig and formulations thereof. The invention further provides for methods for mass-producing CTLA4-Ig from mammalian cells capable of producing this recombinant protein, and for purifying the CTLA4-Ig.

Abstract: Disclosed are methods for generating humoral and cytotoxic T lymphocyte (CTL) immune responses in a subject and related compositions.

Abstract: Methods and kits for purifying protein-nanoparticle conjugates are provided. In some embodiments, a multimodal medium having a size exclusion mode and a capture mode is used to purify the protein-nanoparticle conjugates.

Abstract: The invention provides stable aqueous pharmaceutical formulations comprising a therapeutic antibody, trehalose, a buffer, and optional surfactant, and having a pH in the range of about 5.5 to about 7.0. The invention also provides methods for making such formulations and methods of using such formulations.

Abstract: Disclosed are targeted lipid based particles for delivery of nucleic acid molecules (such as siRNA) to leukocytes (such as T-Cells and B-cells). Further disclosed are uses of the targeted lipid based particles for treating Leukocytes-associated diseases, such as, cancer.

Abstract: Disclosed is a water-in-oil-in-water (W/O/W) double emulsion including a first water phase, an oil phase and a second water phase, wherein the W/O/W double emulsion is disposed in an isotonic solution, and related methods of making the W/O/W double emulsion. Also disclosed is a method of making an artificial antigen presenting cell including: providing a W/O/W double emulsion that is stored in an isotonic solution, wherein the W/O/W double emulsion includes a peptide associated with a Major Histocompatibility (pMHC) complex or a glycolipid antigen associated with a CD1d molecule, and a costimulatory molecule; and transferring the W/O/W double emulsion to an electrolyte solution, wherein the double emulsion undergoes a morphological transformation to become the artificial antigen presenting cell. Also disclosed is a method of drug delivery including administering to a subject a unilamellar vesicle containing the drug.

Abstract: In a broad aspect the present invention generally relates to novel dimer-complexes (herein called “non-fused-dimers” or NFDs) comprising single variable domains, methods of making these complexes and uses thereof. These non-covalently bound dimer-complexes consist of two identical monomers that each comprises of one or more single variable domains (homodimers) or of two different monomers that each comprises on or more single variable domains (heterodimers). The subject NFDs have typically altered e.g. improved binding characteristics over their monomeric counterpart. The NFDs of the invention may further be engineered through linkage by a flexible peptide or cysteines in order to improve the stability. This invention also describes conditions under which such NFDs are formed and conditions under which the formation of such dimers can be avoided.

Abstract: Addition of argininamide or valinamide to a highly concentrated antibody solution was found to lead to remarkable stabilization, in particular, stabilization against photostress.

Abstract: Described herein are methods for maintaining PEGylation and inhibiting dePEGylation of polypeptides, such as fibronectin-based scaffold proteins, during storage.

Abstract: The present invention relates to nanoparticles for the targeted delivery of antigen to liver cells, in particular, liver sinusoidal endothelial cells (LSEC) and/or Kupffer cells, and for the in vivo generation of regulatory T cells, notably CD4+CD25+FOXP3+ regulatory T cells (Treg). The invention provides pharmaceutical compositions and methods for the prevention and treatment of autoimmune diseases, allergies or other chronic inflammatory conditions, and for generation of regulatory T cells. The nanoparticles used in the invention comprise a) a micelle comprising an amphiphilic polymer rendering the nanoparticle water-soluble, and b) a peptide comprising at least one T cell epitope associated with the outside of the micelle. The micelle may or may not comprise a solid hydrophobic core.

Abstract: Bifunctional conjugate compositions are provided comprising a Signal-1 moiety bound to a first polymer carrier, wherein the combined size of the Signal-1 moiety and the first polymer carrier is about 1 nanometer to about 500 nanometers; and a Signal-2 moiety bound to a second polymer carrier, wherein the combined size of the Signal-2 moiety and the second polymer carrier is about 1 nanometer to about 500 nanometers. In some embodiments, the Signal-1 moiety and the Signal-2 moiety are bound to the same polymer carrier. Associated methods are also provided.

Abstract: The invention provides stable aqueous pharmaceutical formulations comprising an anti-PDL1 antibody. The invention also provides methods for making such formulations and methods of using such formulations.

Abstract: The invention provides for mammalian cells capable of producing recombinant CTLA4-Ig and variants thereof. The invention also provides for compositions comprising CTLA4-Ig and formulations thereof. The invention further provides for methods for mass-producing CTLA4-Ig from mammalian cells capable of producing this recombinant protein, and for purifying the CTLA4-Ig.

Abstract: Concentrated, low-viscosity, low-volume liquid pharmaceutical formulations of proteins have been developed. Such formulations can be rapidly and conveniently administered by subcutaneous or intramuscular injection, rather than by lengthy intravenous infusion. These formulations include low-molecular-weight and/or high-molecular-weight proteins, such as mAbs, and viscosity-lowering agents that are typically bulky polar organic compounds, such as many of the GRAS (US Food and Drug Administration List of compounds generally regarded as safe) and inactive injectable ingredients and FDA approved therapeutics.

Abstract: The invention relates to stable, multi-dose liquid compositions containing proteins, in particular, but not exclusively stable antibodies, and to the use of said compositions in therapy, in particular for the subcutaneous delivery of said stable protein.

Abstract: A liposomal vaccine composition comprises a ?-amyloid (A?)-derived peptide antigen displayed on the surface of the liposome. The vaccine composition also comprises a peptide comprising a universal T-cell epitope encapsulated within the liposome. The vaccine composition also comprises an adjuvant, which may form part of the liposome and may be displayed at least in part on the surface of the liposome. These vaccine compositions are used for treating, preventing, inducing a protective immune response against or alleviating the symptoms associated with an amyloid-beta associated disease or condition or a condition characterised by, or associated with, loss of cognitive memory capacity in a subject. The vaccine compositions may be provided as a kit. Related methods of producing a liposomal vaccine composition are also provided.

Abstract: Concentrated, low-viscosity, low-volume liquid pharmaceutical formulations of proteins have been developed. Such formulations can be rapidly and conveniently administered by subcutaneous or intramuscular injection, rather than by lengthy intravenous infusion. These formulations include low-molecular-weight and/or high-molecular-weight proteins, such as mAbs, and viscosity-reducing ionic liquids.

Abstract: Concentrated, low-viscosity, low-volume liquid pharmaceutical formulations of proteins have been developed. Such formulations can be rapidly and conveniently administered by subcutaneous (SC) or intramuscular (IM) injection, rather than by lengthy intravenous infusion. These formulations include low-molecular-weight and/or high-molecular-weight proteins, such as mAbs, and organophosphates. The viscosity of the formulation is significantly reduced by the addition of one or more organophosphates.

Abstract: The invention provides for mammalian cells capable of producing recombinant CTLA4-Ig and variants thereof. The invention also provides for compositions comprising CTLA4-Ig and formulations thereof. The invention further provides for methods for mass-producing CTLA4-Ig from mammalian cells capable of producing this recombinant protein, and for purifying the CTLA4-Ig.

Abstract: The invention provides aqueous pharmaceutical adalimumab compositions suitable for long-term storage of adalimumab, methods of manufacture of these compositions, methods of administration, and kits containing same.