Abstract: The present disclosure provides methods for enriching, identifying, and/or characterizing at least one host cell protein (HCP) impurity in a sample containing a viral vector. The HCP impurities can be enriched through the utilization of a library of bead-based peptide ligands. The enriched HCPs can subsequently be subjected to enzymatic digestion, generating peptides which can be identified by liquid chromatography-mass spectrometry (LC-MS) analysis to specifically identify and/or characterize said at least one HCP impurity.

Abstract: This application relates to various crystalline forms of (S)—N-(4-((5-(1,6-dimethyl-1H-pyrazolo[3,4-b]pyridin-4-yl)-3-methyl-4,5,6,7-tetrahydro-1H-pyrazolo[4,3-c]pyridin-1-yl)methyl)bicyclo[2.2.2]octan-1-yl)morpholine-3-carboxamide in its free form, as well as compositions, method of making and methods of using the same. In some embodiments the crystalline forms also contain water (“hydrates”). These materials are useful in the treatment of various autoimmune diseases, including systemic lupus erythematosus, cutaneous lupus, discoid lupus, mixed connective tissue disease, primary biliary cirrhosis, immune thrombocytopenia purpura, hidradenitis suppurativa, dermatomyositis, polymyositis, Sjögren's syndrome, arthritis, rheumatoid arthritis and psoriasis.

Abstract: The present invention provides a compound, or a pharmaceutically acceptable salt thereof, of formula (I): wherein R1, R2, R3, R4, R5, R26, R27, y, R, M, W, L, V, T, Y, J, K and A are as described herein, therapeutic uses of said compounds, uses of said compounds as research chemicals, a pharmaceutical composition and combinations comprising said compounds, and methods for manufacturing the compounds of the invention.

Abstract: This application relates to various crystalline forms of (S)—N-(4-((5-(1,6-dimethyl-1H-pyrazolo[3,4-b]pyridin-4-yl)-3-methyl-4,5,6,7-tetrahydro-1H-pyrazolo[4,3-c]pyridin-1-yl)methyl)bicyclo[2.2.2]octan-1-yl)morpholine-3-carboxamide in its free form, as well as compositions, method of making and methods of using the same. In some embodiments the crystalline forms also contain water (“hydrates”). These materials are useful in the treatment of various autoimmune diseases, including systemic lupus erythematosus, cutaneous lupus, discoid lupus, mixed connective tissue disease, primary biliary cirrhosis, immune thrombocytopenia purpura, hidradenitis suppurativa, dermatomyositis, polymyositis, Sjögren's syndrome, arthritis, rheumatoid arthritis and psoriasis.

Abstract: The present invention provides a compound, or a pharmaceutically acceptable salt thereof, of formula (I): wherein R1, R2, R3, x, R4, R5, y, R, M, W, L, V, T, Y, J, K and A are as described herein, therapeutic uses of said compounds, uses of said compounds as research chemicals, a pharmaceutical composition and combinations comprising said compounds, and methods for manufacturing the compounds of the invention.

Abstract: The present invention provides methods and systems to identify host cell protein (HCP) impurities in a sample containing high-abundance proteins. The HCP impurities can be enriched using interacting peptide ligands which have been attached to solid support. The HCP impurities can be eluted from the solid support. The isolated HCP impurities can be subjected to limited digestion to generate components of the isolated HCP impurities which can subsequently be identified using a mass spectrometer. The present invention also provides methods and systems to identify sequence variant (SV) peptides or proteins in a sample containing high-abundance proteins. The SV peptides or proteins can be enriched using interacting peptide ligands which have been attached to solid support. The SV peptides or proteins can be eluted from the solid support.

Abstract: The present invention provides a compound, or a pharmaceutically acceptable salt thereof, of formula (I): wherein R1, R2, R3, R4, R5, R26, R27, y, R, M, W, L, V, T, Y, J, K and A are as described herein, therapeutic uses of said compounds, uses of said compounds as research chemicals, a pharmaceutical composition and combinations comprising said compounds, and methods for manufacturing the compounds of the invention.

Abstract: The present invention generally pertains to methods of quantifying free fatty acids in a pharmaceutical formulation. In particular, the present invention pertains to a method of quantifying free fatty acids released from polysorbate hydrolysis in a pharmaceutical formulation comprising a pharmaceutical product, polysorbate and free fatty acids, using liquid chromatography-mass spectrometry, without the use of an extraction step.

Abstract: Methods for identifying a binding site between a protein pharmaceutical product and a host-cell protein (HCP) using hydrogen exchange mass spectrometry are provided. The present application also provides methods to modify protein pharmaceutical products to eliminate the cleavage or modification by HCPs. In addition, the present application provides methods to block the identified binding site in protein pharmaceutical products to eliminate the cleavage or modification by HCPs.

Abstract: The present disclosure pertains to compositions with reduced presence of host-cell proteins and methods of making such compositions. In particular, it pertains to compositions methods of making compositions with reduced presence of host-cell proteins from a host-cell.

Abstract: The present disclosure pertains to compositions with reduced residual amount of lipases and methods of making such compositions. In particular, it pertains to compositions and methods of such making compositions by depleting the compositions of certain lipases, such as, liver carboxylesterase B-1-like protein and liver carboxylesterase 1-like protein.

Abstract: This application relates to various crystalline forms of (S)—N-(4-((5-(1,6-dimethyl-1H-pyrazolo[3,4-b]pyridin-4-yl)-3-methyl-4,5,6,7-tetrahydro-1H-pyrazolo[4,3-c]pyridin-1-yl)methyl)bicyclo[2.2.2]octan-1-yl)morpholine-3-carboxamide in its free-form, as well as compositions, method of making and methods of using the same. In some embodiments the crystalline forms also contain water (“hydrates”). These materials are useful in the treatment of various autoimmune diseases, including systemic lupus erythematosus, cutaneous lupus, discoid lupus, mixed connective tissue disease, primary biliary cirrhosis, immune thrombocytopenia purpura, hidradenitis suppurativa, dermatomyositis, polymyositis, Sjögren's syndrome, arthritis, rheumatoid arthritis and psoriasis.

Abstract: The present disclosure pertains to compositions with reduced presence of host-cell proteins and methods of making such compositions. In particular, it pertains to compositions methods of making compositions with reduced presence of host-cell proteins from a host-cell.