Abstract: The present invention relates to the use of proline for reducing the viscosity of a protein preparation.

Abstract: A nano-sized chitosan/VS2 nanocomposite for use in various pharmaceutical applications. The nano-sized chitosan/VS2 nanocomposite can be formed as a flower nanocomposite.

Abstract: Ophthalmic formulations comprising aflibercept and a lysine salt tonicifying agent are disclosed that are suitable for a method of treatment of an eye disorder or disease by intravitreal or topical administration.

Abstract: The present invention provides a method of treating a subject afflicted with cancer comprising administering to the subject an effective amount of a PP2A inhibitor.

Abstract: A nano-sized chitosan/VS2 nanocomposite for use in various pharmaceutical applications. The nano-sized chitosan/VS2 nanocomposite can be formed as a flower nanocomposite.

Abstract: The invention is in the field of antibody formulations, and particularly relates to a pharmaceutical composition of a humanized monoclonal anti-PD-L1 antibody, wherein the pharmaceutical composition comprises 1-150 mg/ml of the humanized monoclonal anti-PD-L1 antibody, a buffer at 3-50 mM, 2-150 mg/ml of an isotonic adjuster/stabilizer and 0.01-0.8 mg/ml of a surfactant, and has a pH of about 4.5-6.8. The formulations prevent antibody aggregates therein from increasing, while enabling better maintenance of the biological binding activity of the antibody for a long time.

Abstract: The present invention provides a method of producing a recombinant antibody efficiently and at low cost. Disclosed is a method of producing an antibody or a fragment thereof, comprising allowing a cell to produce the antibody or the fragment, wherein the cell contains a larger number of copies of an exogenous DNA encoding the light chain or a fragment thereof of the antibody than the number of copies contained in the cell of an exogenous DNA encoding the heavy chain or a fragment thereof of the antibody. The present invention also provides a recombinant vector comprising one copy of a DNA encoding the heavy chain or a fragment thereof of an antibody and two or more copies of a DNA encoding the light chain or a fragment thereof of the antibody; and a transformant.

Abstract: The invention relates to novel bispecific antigen binding molecules, comprising (a) at least one antigen binding domain capable of specific binding to CD40, and (b) at least one antigen binding domain capable of specific binding to a target cell antigen, in particular Fibroblast Activation Protein (FAP), and to methods of producing these molecules and to methods of using the same.

Abstract: The present invention pertains to a pharmaceutical product comprising a polyclonal immunoglobulin solution in a pre-filled polymer syringe in secondary packaging comprising an oxygen scavenger.

Abstract: The present disclosure provides stable liquid pharmaceutical formulations comprising anti-CD200 antibodies or antigen-binding fragments thereof, and articles of manufacture and kits containing the formulations. Also featured are methods of using the formulations in cancer and autoimmune therapies, and for preventing, delaying or treating cell, tissue, or organ transplant rejection.

Abstract: Disclosed herein are surfactant free antibody and antibody-drug-conjugate (ADC) formulations for anti-AXL antibodies and ADCs, including aqueous formulations, lyophilized formulations, and reconstituted formulations, as well as related processes and uses. The formulations are particularly suitable for an anti-AXL ADC based on an auristatin or DM1 derivative or other similarly hydrophobic drugs. Some formulations comprise histidine and mannitol.

Abstract: The present invention relates to a method for producing an ustekinumab antibody in CHO cells. It further relates to the use of the produced antibody in the treatment of plaque psoriasis, psoriatic arthritis and inflammatory bowel disease.

Abstract: Compositions relating to thermostable vaccines and methods of preparing the same. Specifically, methods of preparing thermostable vaccines based on a recombinant ricin neurotoxin protein and uses of co-adjuvants to develop a composition capable of eliciting an immune response in a subject.

Abstract: The present invention provides compositions comprising emulsion adjuvant and one or more active agents or substances formulated for infusion or injection into a subject (e.g., using a syringe and needle), as well as methods of formulating and using the same (e.g., as an injectable medicinal composition (e.g., a vaccine)). The emulsion adjuvant of an immunogenic composition of the invention in its preferred form comprises a cationic lipid containing a polar head group and a hydrophobic component (e.g., a dual chain hydrophobic group (e.g., the cationic surfactant dioctadecyl dimethyl ammonium chloride (DODAC) and dioctadecyl dimethyl ammonium bromine (DODAB))). Compositions of the invention comprising emulsion adjuvant and one or more active agents or substances formulated for administration via injection to a subject find use in treatment and/or prevention of infectious disease, cancer and/or allergy.

Abstract: The present invention relates to stable and low viscosity liquid pharmaceutical compositions comprising antibodies binding to human alpha synuclein and to methods for use of antibodies binding to human alpha synuclein for treating synucleinopathies or prodromal synucleinopathy, incl. suitable doses and/or dosing regimens. These antibodies for use in treatment of synucleinopathies or prodromal synucleinopathy may be formulated in the stable and low viscosity liquid pharmaceutical compositions of the invention.

Abstract: The present invention provides pharmaceutical formulations comprising a human antibody that specifically binds to human interleukin-6 receptor (hIL-6R). The formulations may contain, in addition to an anti-hIL-6R antibody, at least one amino acid, at least one sugar, and/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.

Abstract: The present invention provides a vaccine containing a complex of a peptide consisting of the amino acid sequence of SEQ ID NO: 1 and an epitope of a disease-causing biological protein such as DPP4, IL-17A, IgE, S100A9 or PCSK9, which vaccine uses a less antigenic carrier protein and is capable of inducing antibody production to serve as an effective vaccine.

Abstract: The present disclosure provides a stable protein composition containing a surfactant and having less than 400 subvisible particles of 10 microns or greater diameter per container, or less than 10,000 subvisible particles of 2 microns or greater per container. A method of manufacturing such a stable protein composition is disclosed, which includes a unit of operation that removes or decreases an esterase activity that degrades the surfactant. The unit of operation may be hydrophobic interaction chromatography or filtration, mixed mode chromatography, or the like.

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: A stable liquid pharmaceutical preparation of an anti-influenza virus antibody and, more specifically, a stable liquid pharmaceutical preparation that comprises: (A) an anti-influenza virus antibody or a mixture of two or more different types of anti-influenza virus antibodies; (B) a surfactant; (C) a sugar or a sugar derivative; and (D) an amino acid. The stable liquid pharmaceutical preparation for an anti-influenza virus antibody disclosed herein has excellent storage stability at low temperature (5° C.), room temperature (25° C.), and high temperature (40° C.) and excellent long-term (12 months) storage stability, and may be administered intravenously, intramuscularly, transdermally, subcutaneously, intraperitoneally, topically, or in combinations thereof.