The present invention relates to compositions comprising erenumab and one or more erenumab variants, including isomerization variants, deamidation variants, acidic variants, and HMW species. Pharmaceutical formulations comprising the erenumab compositions and methods of using and characterizing the compositions are also described.

In certain embodiments, the invention provides a method of purifying a protein of interest from a mixture which comprises the protein of interest and one or more contaminants, comprising: a) subjecting the mixture to a first chromatography step; b) recovering the protein of interest in an elution solution; c) adding caprylic acid to the elution solution to form a contaminant precipitate; d) removing the contaminant precipitate from the elution solution; and e) subjecting the post-precipitated elution solution to a second chromatography column, thereby purifying the protein of interest.

The invention provides a method for controlling contaminants in biopharmaceutical purification processes by using light scattering and UV absorbance to establish a determinant. The invention makes use of multi-angle light scattering (MALS) and UV as a continuous monitoring system to provide information about the elution peak fractions in real-time instead of conventional pooling methods that rely on a predetermined percent UV peak max value to initiate the pooling process; regardless of product quality.

The invention relates to an immunoglobulin composition reduced in thrombogenic agents and to methods for its preparation. One method comprises subjecting an immunoglobulin containing solution to a negative cation exchanger chromatography at a pH in the range of higher than 3.8 to equal to or lower than 5.3. The solution can also be subjected to a negative anion exchanger chromatography at a pH in the range of 7 to 8.2.

The use of scorpion antivenom for the manufacture of a medicament for treatment of hypertension and/or cancer in a subject is disclosed as well as the treatment of the subject.

This invention relates to the application of hydroxyapatite chromatography to the purification of at least one antibody from a preparation containing high molecular weight aggregates. Further, this invention relates to an integration of ceramic hydroxyapatite chromatography into a combination chromatographic protocol for the removal of high molecular weight aggregates from an antibody preparation.

Among other aspects, the present invention provides methods for the manufacture of blood protein compositions from pooled plasma. In one embodiment, the invention provides an alcohol fractionation scheme that allows for significant increases in the yield of blood proteins purified from the starting plasma sample. In a specific embodiment, a method for fractionating pooled plasma is provided, the method comprising an initial low pH, high alcohol precipitation step. The present invention also provides pharmaceutical compositions of therapeutic blood proteins.

The present invention relates to a polypeptide (repebody) selectively bound to an immunoglobulin G, a polynucleotide which encodes the repebody, a vector containing the polynucleotide, a recombinant microorganism in which the polynucleotide is introduced, a method for producing the repebody using the recombinant microorganism, and a method for immobilizing or purifying an immunoglobulin G using the repebody. The repebody according to the present invention is useful as utilized for immobilization of an immunoglobulin G, purification of an immunoglobulin G, and production of an immunosensor, since the repebody selectively bound to an immunoglobulin G.

Disclosed is a method for purification of monoclonal antibodies or of a fusion protein between the Fc segment of an antibody and a second polypeptide, including a) an affinity chromatography step on a resin having as a matrix a crosslinked methacrylate polymer gel, on which the protein A is grafted, b) a viral inactivation step, c) a chromatography step exchanging cations on a resin having a crosslinked agarose gel matrix, on which sulfonate groups (—SO.sub.3—) are grafted using dextran-based spacer arms, d) a chromatography step exchanging anions on a hydrophilic membrane of polyethersulfone coated with a crosslinked polymer on which quaternary amine groups (Q) are grafted, and e) a nanofiltration step using a filter having an asymmetric polyethersulfone double membrane with a porosity of approximately 20 nm.

Camelid blood products their peptide isolates and synthetic sequences for wound fluid elevated protease enzyme inhibition. The present invention provides evidence that Metalloprotease and other Protease enzyme (e.g. elastase) peptide inhibitors are present in camelid serum/plasma can be used alone or combined with other agents to enhance healing in the treatment of chronic wounds and burns by inhibiting elevated wound fluid protease activity. These protease enzymes inhibitors present in camelid serum/plasma can be demonstrated to inhibit chronic non-healing wound fluid proteolytic enzymes by the use of wound fluid assay kits specifically designed to measure wound fluid protease activity. The serum/plasma and isolated or synthesised peptides of this patent have use in the treatment of a range of cosmetic skin indications and diseases such as disorders of the gastrointestinal tract, cardiovascular conditions and specifically in the treatment of wound healing and burns and in scar tissue healing.