A61K39/39591

LOW-VISCOSITY, HIGH CONCENTRATION EVOLOCUMAB FORMULATIONS AND METHODS OF MAKING THE SAME

Provided herein are formulations of PCSK9-binding polypeptides, such as those comprising evolocumab, that comprise N-acetyl arginine and have reduced viscosities when compared to formulations lacking N-acetyl arginine. Provided herein are also methods of formulating such compositions that are advantageous in that they conserve certain components. Such formulations comprising PCSK9-binding polypeptides can be administered to patients to treat and/or prevent PCSK9-related diseases, conditions, and disorders.

EXCIPIENT COMPOUNDS FOR BIOPOLYMER FORMULATIONS

Disclosed herein are reduced viscosity liquid formulations comprising a protein and an excipient compounds. Further disclosed are methods of reducing the viscosity of a liquid formulation comprising a protein, methods of treatment, and methods of improving protein processing.

Formulation for anti-α4β7 antibody

Antibody formulations are described comprising a mixture of an anti-α4β7 antibody, an antioxidant or chelator, and at least one free amino acid. The disclosed formulations may have improved stability, reduced aggregate formation, or both. The present invention further provides a safe dosing regimen of these antibody formulations that is easy to follow, and which results in a therapeutically effective amount of the anti-α4β7 antibody in vivo.

Viscosity-reducing compounds for protein formulations

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.

Anti-IL31 antibodies for veterinary use

Provided are various embodiments relating to anti-IL31 antibodies binding to canine IL31. Such antibodies can be used in methods to treat IL31-induced conditions in companion animals, such as canines, felines, and equines.

Methods for purifying antibodies having reduced high molecular weight aggregates
11697670 · 2023-07-11 · ·

Provided herein, in some embodiments, are methods and compositions for purifying antibodies from cellular cultures using one or more thiol containing additives during a purification process, for example in a chromatographic purification process.

ADOPTIVE IMMUNOTHERAPY
20230210984 · 2023-07-06 ·

Disclosed herein is the use of a first population of allogeneic T-cells recognizing a first EBV epitope, and a second allogeneic population recognizing a second EBV epitope in the treatment of EBV-associated disorders. Also disclosed is the use of a population of allogeneic T-cells recognizing an EBV antigen in combination with a further therapeutic agent such as an immunotherapeutic agent, a MAPK, BET or MEK. pathway inhibitor for treating EBV-associated disease.

ADOPTIVE IMMUNOTHERAPY
20230210984 · 2023-07-06 ·

Disclosed herein is the use of a first population of allogeneic T-cells recognizing a first EBV epitope, and a second allogeneic population recognizing a second EBV epitope in the treatment of EBV-associated disorders. Also disclosed is the use of a population of allogeneic T-cells recognizing an EBV antigen in combination with a further therapeutic agent such as an immunotherapeutic agent, a MAPK, BET or MEK. pathway inhibitor for treating EBV-associated disease.

ANTIBODY-CONTAINING FORMULATION

In one non-limiting embodiment, the present disclosure is an antibody-containing formulation comprising an anti-IL-6 receptor antibody as an active ingredient, and contains histidine-aspartate buffer or histidine-glutamate buffer, Poloxamer 188, and arginine, and has a pH of 5.5 to 6.6. In one non-limiting embodiment, the present disclosure is a method of stabilizing an antibody-containing solution, a method of suppressing antibody association (e.g., dimerization), and a method of suppressing the generation of insoluble particles, wherein L-aspartic acid or L-glutamic acid, and optionally, Poloxamer 188 are added.

FGF21 mimetic antibodies and uses thereof
11692046 · 2023-07-04 · ·

The present disclosure relates to monoclonal antibodies and antigen-binding fragments thereof that bind to human β-klotho, and pharmaceutical compositions and methods of treatment comprising the same.