C07K1/14

Method for producing low viscous and highly concentrated biopharmaceutical drug products in liquid formulation

The present invention relates to a method of producing low viscous and highly concentrated biopharmaceutical drug products comprising a biomolecule of interest, the method comprising: (a) a first phase of preparing a drug substance of the biomolecule of interest, said first phase comprising at least one processing step selected from (a1) harvesting, (a2) purification, (a3) re-buffering, and (a4) enrichment, wherein said at least one processing step in this first phase is carried out in the presence of a composition comprising at least three amino acids, wherein the combination of said at least three amino acids provides at least one positively charged functional group, at least one anti-oxidative functional group, at least one osmolytic function, and at least one buffering function, and (b) a second phase of further processing the drug substance prepared in (a) to obtain a low viscous and highly concentrated biopharmaceutical drug product, said second phase comprising at least one processing step selected from (b1) re-buffering, (b2) freezing, (b3) thawing, and (b4) filling; wherein said at least one processing step in this second phase is carried out in the presence of a composition comprising (i) at least three amino acids, wherein the combination of said at least three amino acids provides at least one positively charged functional group, at least one anti-oxidative functional group, at least one osmolytic function, and at least one buffering function; and (ii) one or more sugar(s); in an amino acid:sugar ratio between 10:1 to 1:100 (w/w). The present invention further relates to a low viscous and highly concentrated biopharmaceutical drug product obtained or obtainable by the method of the invention.

Method for producing low viscous and highly concentrated biopharmaceutical drug products in liquid formulation

The present invention relates to a method of producing low viscous and highly concentrated biopharmaceutical drug products comprising a biomolecule of interest, the method comprising: (a) a first phase of preparing a drug substance of the biomolecule of interest, said first phase comprising at least one processing step selected from (a1) harvesting, (a2) purification, (a3) re-buffering, and (a4) enrichment, wherein said at least one processing step in this first phase is carried out in the presence of a composition comprising at least three amino acids, wherein the combination of said at least three amino acids provides at least one positively charged functional group, at least one anti-oxidative functional group, at least one osmolytic function, and at least one buffering function, and (b) a second phase of further processing the drug substance prepared in (a) to obtain a low viscous and highly concentrated biopharmaceutical drug product, said second phase comprising at least one processing step selected from (b1) re-buffering, (b2) freezing, (b3) thawing, and (b4) filling; wherein said at least one processing step in this second phase is carried out in the presence of a composition comprising (i) at least three amino acids, wherein the combination of said at least three amino acids provides at least one positively charged functional group, at least one anti-oxidative functional group, at least one osmolytic function, and at least one buffering function; and (ii) one or more sugar(s); in an amino acid:sugar ratio between 10:1 to 1:100 (w/w). The present invention further relates to a low viscous and highly concentrated biopharmaceutical drug product obtained or obtainable by the method of the invention.

METHODS FOR ISOLATING SPIDER SILK PROTEINS VIA HIGH SHEAR SOLUBILIZATION
20220372086 · 2022-11-24 ·

The present disclosure relates to methods of isolating and purifying synthetic block copolymer proteins via the application of solvents and high shear microfluidization methods.

Compositions of prokaryotic phenylalanine ammonia-lyase variants and methods of using compositions thereof

Provided herein are phenylalanine ammonia-lyase (PAL) variants produced by prokaryotes, wherein such prokaryotic PAL variant has a greater phenylalanine-converting activity and/or a reduced immunogenicity as compared to a wild-type PAL. Further provided are compositions of prokaryotic PAL and biologically active fragments, mutants, variants or analogs thereof, as well as methods for the production, purification, formulation, and use of such compositions for industrial and therapeutic purposes, e.g., treating hyperphenylalaninemia, including phenylketonuria, and other disorders, including cancer.

Method for separating larvae in a pulp and a liquid fraction

The present invention relates to a method for separating larvae into a pulp fraction and a liquid fraction, including the steps of introducing living larvae into a grinding apparatus whist adding water, grinding the larvae by means of counter-rotating screws and separating the ground biomass of larvae into a pulp and liquid fraction. In particular, the invention is applicable to the larvae of the black soldier fly and produces a chitin-rich pulp and a fat-and-protein-rich liquid fraction.

Method for separating larvae in a pulp and a liquid fraction

The present invention relates to a method for separating larvae into a pulp fraction and a liquid fraction, including the steps of introducing living larvae into a grinding apparatus whist adding water, grinding the larvae by means of counter-rotating screws and separating the ground biomass of larvae into a pulp and liquid fraction. In particular, the invention is applicable to the larvae of the black soldier fly and produces a chitin-rich pulp and a fat-and-protein-rich liquid fraction.

Polypeptides based on a scaffold

The disclosure provides a population of polypeptide variants based on a common scaffold, each polypeptide in the population comprising the scaffold amino acid sequence X.sub.sc1AELDX.sub.sc2X.sub.sc3GVG AXXIKXIX.sub.sc4XA XXVEXVQXXK QXILAX. The disclosure also provides methods for selecting and identifying polypeptides from the population, as well as such polypeptides themselves.

Polypeptides based on a scaffold

The disclosure provides a population of polypeptide variants based on a common scaffold, each polypeptide in the population comprising the scaffold amino acid sequence X.sub.sc1AELDX.sub.sc2X.sub.sc3GVG AXXIKXIX.sub.sc4XA XXVEXVQXXK QXILAX. The disclosure also provides methods for selecting and identifying polypeptides from the population, as well as such polypeptides themselves.

METHODS FOR HARVESTING BIOMOLECULES
20230058276 · 2023-02-23 ·

The disclosure provides methods of purifying native and recombinant biomolecules, e.g., proteins, from mammalian cells using purification protocols incorporating harvest recovery operations involving decanter centrifugation of at least one target biomolecule from at least one particulate component of cell culture fluid. The unexpected capacity of decanter centrifuge separation of biological materials of similar densities found in mammalian cell culture fluid has been found to yield high quantities of functional protein in efficient, low-cost harvest recovery steps of biomolecule purification protocols.

High concentration antibody-containing liquid formulation

The problem to be solved is to provide a humanized anti-IL-6 receptor antibody MRA-containing formulation which is suitable for subcutaneous administration, wherein dimerization or deamidation is prevented during long-term storage. The present application is directed to a stable antibody-containing liquid formulation characterized by containing arginine and histidine buffer. A method of inhibiting deamidation or dimerization of such an antibody in a concentrated liquid formulation includes histidine buffer in the liquid formulation.