A61K39/39525

HYPERIMMUNE IGG AND/OR IGM COMPOSITIONS AND METHOD FOR PREPARING THEREOF AND METHOD FOR OBTAINING HYPERIMMUNE HUMAN PLASMA FROM A DONOR

Hyperimmune IgG and/or IgM compositions and method for preparing thereof and method for obtaining hyperimmune human plasma from a donor. A liquid therapeutic hyperimmune globulin composition including human plasma-derived immunoglobulin G (IgG) having antibody titre between 250 and 2,500 per mg/mL of IgG and/or a SARS-CoV-2 neutralization activity (IC50 neutralization titer) between 1.5 and 15 per mg/mL of IgG for use in the treatment of coronavirus disease 2019 (COVID-19) in a patient in need thereof. A liquid therapeutic or prophylactic hyperimmune immunoglobulin composition including human plasma-derived immunoglobulin M (IgM) having a SARS-CoV-2 titre between 2,000 and 17,000 and/or a SARS-CoV-2 neutralization activity (IC50 neutralization titre) between 200 and 70,000, methods for preparing thereof, and the use thereof for the treatment or prophylaxis of COVID-19. A method for obtaining hyperimmune human plasma from a donor for use in the treatment of COVID-19.

MODIFIED TNF AS A CAPTURE LIGAND

A column is disclosed for removal of sTNF-R2 from a body fluid. The column has a compartment, an inlet coupled to the compartment and configured to receive the body fluid, and a substrate disposed within the compartment. A capture ligand is coupled to the substrate and has a modified sequence with an amino acid substitution in a reference sequence that includes a portion of a natural TNF sequence. The modified sequence has an affinity for the sTNF-R2 that is greater than an affinity of the reference sequence for the sTNF-R2.

Method for purification of immunoglobulin

The present invention relates to an improved method of purifying an immunoglobulin, and more particularly to a method of purifying an immunoglobulin which is capable of sufficiently removing impurities from an immunoglobulin-containing plasma protein sample through a simple process, comprising a single anion-exchange chromatography and a single cation-exchange chromatography.

Method for Reduced Aggregate Formation in Downstream Processing of Bispecific Antigen-Binding Molecules

The present disclosure provides a downstream manufacturing method for the production of bispecific antigen-binding molecule products, which comprise at least two different binding domains. The process comprises at least one filtration step, wherein the filtration is ultrafiltration/diafiltration (UF/DF), and/or viral filtration (VF), wherein a β-cyclodextrin is applied in the process either in a buffer applied in the filtration step or added to the filtration pool after the UF/DF filtration step wherein the buffer or the pool have a concentration of about 0.1 to 3% (m/v) of a (3-cyclodextrin, to preferably keep the product in a non-aggregated form.

Anti-CCR7 antibody drug conjugates

This application discloses anti-CCR7 antibodies, antigen binding fragments thereof, and antibody drug conjugates of said antibodies or antigen binding fragments. The invention also relates to methods of treating or preventing cancer using the antibodies, antigen binding fragments, and antibody drug conjugates. Also disclosed herein are methods of making the antibodies, antigen binding fragments, and antibody drug conjugates, and methods of using the antibodies and antigen binding fragments as diagnostic reagents.

Process technology for biological product manufacturing and downstream purification

Provided herein are, inter alia, biological manufacturing and downstream purification processes.

COMPOSITIONS AND METHODS FOR PRODUCING HUMAN POLYCLONAL ANTIBODIES

The disclosure provides compositions and methods for generating polyclonal antibodies, for example, using circular polyribonucleotides and non-human animals having humanized immune systems.

PROCESS TECHNOLOGY FOR BIOLOGICAL PRODUCT MANUFACTURING AND DOWNSTREAM PURIFICATION

Provided herein are, inter alia, biological manufacturing and downstream purification processes.

METHODS OF PREPARING PROTEIN-OLIGONUCLEOTIDE COMPLEXES
20220306685 · 2022-09-29 · ·

Aspects of the disclosure relate to methods of purifying complexes comprising a protein (e.g., antibody) covalently linked to an oligonucleotide. In some embodiments, complexes comprising a protein covalently linked to an oligonucleotide are purified and isolated from unlinked oligonucleotide using an mixed-mode resin that comprises positively-charged metal sites and negatively charged ionic sites, e.g., hydroxyapatite resin. In some embodiments, complexes comprising a protein covalently linked to an oligonucleotide are purified from a mixture comprising the complexes, unlinked protein, and unlinked oligonucleotide using a purification step involving hydrophobic interaction chromatography resin followed by a purification step involving mixed-mode resin.