Abstract: 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.

Abstract: 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.

Abstract: This invention relates to methods of using weak partitioning chromatography for the purification of a product from a load fluid containing one or more impurities. Further, the invention relates to methods of weak partitioning chromatography defined by operating conditions which cause a medium to bind least 1 mg of product per mL of medium, or alternatively, defined by a partition coefficient of at least 0.1.

Abstract: The invention relates to methods for isolating a product and/or reducing turbidity and/or impurities from a load fluid comprising the product and one or more impurities by passing the load fluid through a medium, followed by at least one wash solution comprising arginine, and collecting the product using an elution solution. The invention further relates to a product prepared using a method as described herein.

Abstract: This invention relates to methods of using weak partitioning chromatography for the purification of a product from a load fluid containing one or more impurities. Further, the invention relates to methods of weak partitioning chromatography defined by operating conditions which cause a medium to bind least 1 mg of product per mL of medium, or alternatively, defined by a partition coefficient of at least 0.1.

Abstract: The present invention provides, among other things, methods of purifying or recovering proteins, in particular, small modular immunopharmaceutical (SMIPs™) proteins, from protein preparations containing high molecular weight (HMW) aggregates and other impurities based on hydroxyapatite chromatography. In some embodiments, the hydroxyapatite chromatography is used in combination with affinity chromatography and/or ion exchange chromatography. In some embodiments, inventive methods according to the invention involve no more than three chromatography steps. The present invention also provides proteins such as SMIPs™ purified according to the invention and pharmaceutical compositions containing the same.

Abstract: This invention relates to methods of using weak partitioning chromatography for the purification of a product from a load fluid containing one or more impurities. Further, the invention relates to methods of weak partitioning chromatography defined by operating conditions which cause a medium to bind least 1 mg of product per mL of medium, or alternatively, defined by a partition coefficient of at least 0.1.

Abstract: The present invention provides a method of removing product-related inactive or partially active species, high molecular weight aggregates, as well as other process-related impurities from preparations of acidic proteins by using ceramic hydroxyapatite chromatography.

Abstract: The invention relates to methods for isolating a product and/or reducing turbidity and/or impurities from a load fluid comprising the product and one or more impurities by passing the load fluid through a medium, followed by at least one wash solution comprising an arginine derivative, and collecting the product using an elution solution. The invention further relates to a product prepared using a method as described herein.

Abstract: The present invention provides a method of removing product-related inactive or partially active species, high molecular weight aggregates, as well as other process-related impurities from preparations of acidic proteins by using ceramic hydroxyapatite chromatography.

Abstract: The invention relates to methods for isolating a product and/or reducing turbidity and/or impurities from a load fluid comprising the product and one or more impurities by passing the load fluid through a medium, followed by at least one wash solution comprising an arginine derivative, and collecting the product using an elution solution. The invention further relates to a product prepared using a method as described herein.

Abstract: The invention relates to methods for isolating a product and/or reducing turbidity and/or impurities from a load fluid comprising the product and one or more impurities by passing the load fluid through a medium, followed by at least one wash solution comprising arginine, and collecting the product using an elution solution. The invention further relates to a product prepared using a method as described herein.

Abstract: The present invention provides a process for dissociating Fc-containing molecules from complexes of Protein A/Fc-containing molecules or mixtures containing Fc-containing molecules and Protein A. The association, e.g., by hydrophobic interactions, between the Fc-containing molecules and Protein A can be reduced or inhibited by raising the pH of dissociation. The pH of dissociation can be raised by addition of agents capable of inhibiting hydrophobic interactions, including buffers containing arginine and/or ethylene glycol, to the mixture, either prior to adding the mixture to the column chromatography substrate, after adding the mixture to the column chromatography substrate, or both prior to and after adding the mixture to the column chromatography substrate.

Abstract: This invention relates to methods of using weak partitioning chromatography for the purification of a product from a load fluid containing one or more impurities. Further, the invention relates to methods of weak partitioning chromatography defined by operating conditions which cause a medium to bind least 1 mg of product per mL of medium, or alternatively, defined by a partition coefficient of at least 0.1.

Abstract: This invention relates to methods of using weak partitioning chromatography for the purification of a product from a load fluid. Further, the invention relates to methods of weak partitioning chromatography defined by operating conditions which cause a medium to bind least 1 mg of product per mL of medium, or alternatively, defined by a partition coefficient of at least 0.1.

Abstract: This disclosure provides methods for the detection of antibodies to a GDF-8 modulating agent such as, e.g., MYO-029, in a biological sample. Methods to detect an immune response to a GDF-8 modulating agent are also included. In particular, methods to assess an immune response in animals, including humans, to a GDF-8 modulating agent such as a GDF-8 inhibitor are provided herein.

Abstract: Methods to detect GDF-8 modulating agents in animals, including humans, are provided herein, including methods to detect the presence of exogenous GDF-8 modulating agent such as a GDF-8 inhibitor in a biological sample. In particular, methods to assess the presence and/or quantity of a GDF-8 modulating agent in a biological sample are provided.

Abstract: The present invention provides a process for isolating and purifying highly anionic target proteins, for example, sulfated proteins. Sulfated proteins have five (5) or more, sulfations. In a preferred embodiment, the sulfated protein has six (6) sulfations, e.g., six sulfations on N-terminal tyrosine residues, as embodied in PSGL-1 (P-selectin glycoprotein ligand).

Abstract: 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.

Abstract: The present invention provides a process for dissociating Fc containing molecules from complexes of Protein A/Fc containing molecules.