http://rdf.ncbi.nlm.nih.gov/pubchem/patent/AR-109494-A1
Outgoing Links
| Predicate | Object |
|---|---|
| assignee | http://rdf.ncbi.nlm.nih.gov/pubchem/patentassignee/MD5_aca152ba4602da5909c80dcbdef46ef5 |
| classificationCPCAdditional | http://rdf.ncbi.nlm.nih.gov/pubchem/patentcpc/C07K2317-94 http://rdf.ncbi.nlm.nih.gov/pubchem/patentcpc/A61K2039-545 |
| classificationCPCInventive | http://rdf.ncbi.nlm.nih.gov/pubchem/patentcpc/A61K47-26 http://rdf.ncbi.nlm.nih.gov/pubchem/patentcpc/A61K47-183 http://rdf.ncbi.nlm.nih.gov/pubchem/patentcpc/A61K47-12 http://rdf.ncbi.nlm.nih.gov/pubchem/patentcpc/A61P25-26 http://rdf.ncbi.nlm.nih.gov/pubchem/patentcpc/C07K16-40 http://rdf.ncbi.nlm.nih.gov/pubchem/patentcpc/A61P7-02 http://rdf.ncbi.nlm.nih.gov/pubchem/patentcpc/A61K9-0019 http://rdf.ncbi.nlm.nih.gov/pubchem/patentcpc/A61K39-3955 http://rdf.ncbi.nlm.nih.gov/pubchem/patentcpc/A61P7-06 http://rdf.ncbi.nlm.nih.gov/pubchem/patentcpc/A61P13-12 http://rdf.ncbi.nlm.nih.gov/pubchem/patentcpc/A61K9-08 |
| classificationIPCInventive | http://rdf.ncbi.nlm.nih.gov/pubchem/patentipc/A61K47-26 http://rdf.ncbi.nlm.nih.gov/pubchem/patentipc/A61K9-10 http://rdf.ncbi.nlm.nih.gov/pubchem/patentipc/A61P13-00 http://rdf.ncbi.nlm.nih.gov/pubchem/patentipc/A61P9-10 http://rdf.ncbi.nlm.nih.gov/pubchem/patentipc/A61P37-06 http://rdf.ncbi.nlm.nih.gov/pubchem/patentipc/A61K47-18 http://rdf.ncbi.nlm.nih.gov/pubchem/patentipc/A61K9-08 |
| filingDate | 2017-08-31-04:00^^<http://www.w3.org/2001/XMLSchema#date> |
| inventor | http://rdf.ncbi.nlm.nih.gov/pubchem/patentinventor/MD5_9c02e881894335fc8804c58f0394589e http://rdf.ncbi.nlm.nih.gov/pubchem/patentinventor/MD5_46d1214506ebe605cc38d4905a671ea9 http://rdf.ncbi.nlm.nih.gov/pubchem/patentinventor/MD5_3b05515bac4b3d27bb7824b07819a522 http://rdf.ncbi.nlm.nih.gov/pubchem/patentinventor/MD5_9ab1aaff0d5ace0b537a0b4e32ee7e42 |
| publicationDate | 2018-12-12-04:00^^<http://www.w3.org/2001/XMLSchema#date> |
| publicationNumber | AR-109494-A1 |
| titleOfInvention | FORMULATIONS OF INHIBITING ANTIBODIES OF LOW VISCOSITY MASP-2 AND HIGHLY CONCENTRATED, KITS, AND METHODS |
| abstract | This refers to high concentration and low viscosity formulations of MASP-2 inhibitor antibodies, kits comprising formulations and therapeutic methods that use formulations and kits to inhibit the adverse effects of MASP-2-dependent complement activation. Claim 1: A stable pharmaceutical formulation suitable for parenteral administration to a mammalian subject, comprising: (a) an aqueous solution comprising a buffer system with a pH of 5.0 to 7.0; and (b) a monoclonal antibody or fragment thereof that specifically binds to human MASP-2 at a concentration of about 50 mg / mL to about 250 mg / mL, where such antibody or fragment thereof comprises (i) a heavy chain variable region comprising the amino acid sequence established in SEQ ID No. 2 and (ii) a light chain variable region comprising the amino acid sequence established in SEQ ID No. 3; where the formulation has a viscosity between 2 and 50 centipoise (cP), and where the formulation is stable when stored between 2ºC and 8ºC for at least six months. Claim 38: The pharmaceutical formulation of claim 1, wherein the formulation comprises: about 20 mM sodium citrate, about 200 mM L-arginine HCl, wherein the concentration of the antibody in the formulation is about 175 mg / mL at about 195 mg / mL, and where the viscosity is less than about 25 cP. Claim 40: The pharmaceutical formulation of claim 1, wherein the formulation comprises: about 20 mM of L-histidine, about 200 mM of L-arginine HCl, wherein the concentration of the antibody in the formulation is about 175 mg / mL at about 195 mg / mL, and where the viscosity is less than about 25 cP. Claim 44: The pharmaceutical formulation of claim 43, wherein the antibody is a human IgG4 full length antibody. Claim 58: A stable aqueous pharmaceutical formulation suitable for parenteral administration to a mammalian subject, wherein the formulation consists essentially of: (a) polysorbate 80 at a concentration of about 0.01 to about 0.08% w / v; (b) L-arginine HCl a concentration of about 150 mM to about 200 mM; (c) sodium citrate at a concentration of about 10 mM to about 50 mM; and (d) a monoclonal antibody or fragment thereof that specifically binds to human MASP-2 at a concentration of about 150 mg / mL to about 200 mg / mL, where such antibody or fragment thereof comprises (i) a heavy chain variable region comprising the amino acid sequence established in SEQ ID No. 2 and (ii) a light chain variable region comprising the amino acid sequence established in SEQ ID No. 3; where the formulation has a pH of about 5.0 to about 7.0, a viscosity between 2 and 50 centipoise (cP), and where the formulation is stable when stored between 2 ° C and 8 ° C for at least six months. Claim 59: A stable aqueous pharmaceutical formulation suitable for parenteral administration to a mammalian subject, wherein the formulation consists essentially of: (a) polysorbate 80 at a concentration of about 0.01 to about 0.08% w / v; (b) L-arginine HCl at a concentration of about 150 mM to about 200 mM; (c) L-histidine at a concentration of about 10 mM to about 50 mM; and (d) a monoclonal antibody or fragment thereof that specifically binds to human MASP-2 at a concentration of about 150 mg / mL to about 200 mg / mL, where such antibody or fragment thereof comprises (i) a heavy chain variable region comprising the amino acid sequence established in SEQ ID No. 2 and (ii) a light chain variable region comprising the amino acid sequence established in SEQ ID No. 3; where the formulation has a pH of about 5.0 to about 7.0, a viscosity between 2 and 50 centipoise (cP), and where the formulation is stable when stored between 2 ° C and 8 ° C for at least six months. Claim 60: A sealed container containing a formulation according to any of claims 1, 58 or 59. Claim 61: A subcutaneous delivery device containing the formulation of any of claims 1, 58 or 59 herein. Claim 62: A kit comprising a prefilled container comprising the pharmaceutical formulation comprising the MASP-2 antibody of any of claims 1, 58 or 59 and instructions for using the formulation. Claim 63: The kit of claim 62 wherein the prefilled container is selected from the group consisting of: a syringe, a pen injector, a sealed vial, an auto-injector and a pump device. Claim 67: A method of treating a subject suffering from a disease or disorder associated with the MASP-2-dependent complement comprising administering a formulation of any of claims 1, 58 or 59 to the subject in need. |
| priorityDate | 2016-08-31-04:00^^<http://www.w3.org/2001/XMLSchema#date> |
| type | http://data.epo.org/linked-data/def/patent/Publication |
Incoming Links
Total number of triples: 42.