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. Also provided is the transscleral, transcorneal or transocular delivery of high molecular weight, biologically active substances to a patient, with or without pulsed infrared (IR) light. The compositions may also incorporate nanotechnologies to formulate the active substances.

The present disclosure provides pharmaceutical compositions comprising fibronectin based scaffold domain proteins that bind, for example, proprotein convertase subtilisin kexin-9 (PCSK9).

The present invention provides antibodies having improved stability. Included are antibodies that are capable of binding to KIR3DL2 polypeptides. The antibodies are suitable for the treatment of disorders characterized by KIR3DL2-expressing cells, particularly CD4+ T cells, including malignancies such as Mycosis Fungoides and Sezary Syndrome, and KIR3DL2-expressing autoimmune disorders.

A composition comprising a protein and at least one single-stranded linear RNA oligonucleotide with an unfolded tertiary structure, which is characterized by: a) a relative content of each of the nucleotides A, C, U, and G, which is the number of each of the nucleotides per total nucleotide number in the oligonucleotide, which relative content is the same ±10% (number of nucleotides per total nucleotide number) as compared to the relative content of the respective nucleotide in a reference; and/or b) a relative content of at least 50% (number of nucleotides per total nucleotide number) of one type of nucleotide selected from the group consisting of nucleotides A, C, U, and G, which exhibits the highest relative content (number of each of the nucleotides per total nucleotide number) in a reference; wherein the reference consists of a native mRNA or a set of different RNA sequences that covers all RNA sequences allowed by the universal genetic code, each encoding an amino acid sequence of at least three amino acids within a p re-determined aggregation-prone target region of said protein, wherein the oligonucleotide has a length which is the same length as the reference, or longer.

The present invention relates to novel liquid pharmaceutical compositions of adalimumab, which include adalimumab or a biosimilar thereof, arginine and/or methionine, and a small polyol stabiliser such as glycerol. Such a combination of components furnishes formulations having a stability (e.g. on storage and when exposed to stress) which is comparable to or an improvement upon those known in the art, and with fewer ingredients. Such advances will help adalimumab treatments to become more widely available at lower cost, and prolong the viability of pre-loaded delivery devices (e.g. pre-filled syringes) to reduce unnecessary waste of the drug.

The present invention relates to novel liquid pharmaceutical compositions of adalimumab, which include adalimumab or a biosimilar thereof, EDTA, and a small polyol stabiliser such as glycerol. Such a combination of components furnishes formulations having a stability (e.g. on storage and when exposed to stress) which is comparable to or an improvement upon those known in the art, and with fewer ingredients. Such advances will help adalimumab treatments to become more widely available at lower cost, and prolong the viability of pre-loaded delivery devices (e.g. pre-filled syringes) to reduce unnecessary waste of the drug.

Disclosed herein are multivalent and multispecific binding proteins, methods of making the binding proteins, and their uses in the diagnosis, monitoring, inhibition, prevention and/or treatment of cancers, tumors, and/or other angiogenesis-dependent diseases diseases characterized by aberrant DLL4 and/or VEGF expression or activity.

A pharmaceutical composition for improving insulin sensitivity in diseases accompanied by impaired glucose tolerance is disclosed. The pharmaceutical composition contains an antibody or an antigen-binding fragment thereof that specifically recognizes ITIH1 exhibiting increased expression in diseases accompanying high blood sugar. The pharmaceutical composition can be effectively used for improving insulin sensitivity in various diseases accompanying high blood sugar.

Disclosed herein are formulations with improved stability or reduced viscosity that comprise a therapeutic protein and a lyo-enhancing excipient, wherein the improved stability formulation is characterized by improved stability in comparison to a control formulation otherwise identical to the stability-enhanced formulation but lacking the lyo-enhancing excipient, and the reduced viscosity formulation is characterized by reduced viscosity in comparison to a control formulation otherwise identical to the reduced viscosity formulation but lacking the lyo-enhancing excipient. Further disclosed herein are methods of improving stability of therapeutic formulations, reducing viscosity of therapeutic formulations, or improving parameters of lyophilization processes.

The present invention provides methods to prevent the formation of visible particles in aqueous protein formulations, as well as compositions and pharmaceutical products obtained with said method.