MXPA04003640A - Formulaciones de proteina de alta concentracion y metodo de fabricacion. - Google Patents
Formulaciones de proteina de alta concentracion y metodo de fabricacion.Info
- Publication number
- MXPA04003640A MXPA04003640A MXPA04003640A MXPA04003640A MXPA04003640A MX PA04003640 A MXPA04003640 A MX PA04003640A MX PA04003640 A MXPA04003640 A MX PA04003640A MX PA04003640 A MXPA04003640 A MX PA04003640A MX PA04003640 A MXPA04003640 A MX PA04003640A
- Authority
- MX
- Mexico
- Prior art keywords
- protein
- mixture
- pharmaceutical composition
- percent
- concentration
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title claims abstract description 304
- 102000004169 proteins and genes Human genes 0.000 title claims abstract description 301
- 108090000623 proteins and genes Proteins 0.000 title claims abstract description 301
- 238000000034 method Methods 0.000 title claims abstract description 85
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 22
- 238000009472 formulation Methods 0.000 title claims description 22
- 239000007788 liquid Substances 0.000 claims abstract description 98
- 229920000249 biocompatible polymer Polymers 0.000 claims abstract description 74
- 239000008194 pharmaceutical composition Substances 0.000 claims abstract description 71
- 238000001556 precipitation Methods 0.000 claims abstract description 40
- 230000001376 precipitating effect Effects 0.000 claims abstract description 23
- 238000012545 processing Methods 0.000 claims abstract description 22
- 239000012141 concentrate Substances 0.000 claims abstract description 8
- 239000000243 solution Substances 0.000 claims description 81
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 48
- 229920000642 polymer Polymers 0.000 claims description 47
- 239000003795 chemical substances by application Substances 0.000 claims description 39
- 238000003860 storage Methods 0.000 claims description 37
- 230000002441 reversible effect Effects 0.000 claims description 29
- 238000010790 dilution Methods 0.000 claims description 23
- 239000012895 dilution Substances 0.000 claims description 23
- 239000007924 injection Substances 0.000 claims description 23
- 238000002347 injection Methods 0.000 claims description 23
- 229920001400 block copolymer Polymers 0.000 claims description 20
- 229940124272 protein stabilizer Drugs 0.000 claims description 19
- 238000001248 thermal gelation Methods 0.000 claims description 18
- 239000004094 surface-active agent Substances 0.000 claims description 16
- 239000002244 precipitate Substances 0.000 claims description 14
- 238000007710 freezing Methods 0.000 claims description 8
- 230000008014 freezing Effects 0.000 claims description 8
- 238000002360 preparation method Methods 0.000 claims description 8
- 239000000047 product Substances 0.000 claims description 8
- 238000000710 polymer precipitation Methods 0.000 claims description 7
- 238000007865 diluting Methods 0.000 claims description 6
- 239000007864 aqueous solution Substances 0.000 claims description 5
- 238000002156 mixing Methods 0.000 claims description 5
- 238000012856 packing Methods 0.000 claims description 4
- 238000004090 dissolution Methods 0.000 claims description 3
- 238000004806 packaging method and process Methods 0.000 claims description 2
- 239000006193 liquid solution Substances 0.000 claims 1
- 239000002609 medium Substances 0.000 description 23
- 229920001983 poloxamer Polymers 0.000 description 18
- 230000002601 intratumoral effect Effects 0.000 description 17
- 238000000926 separation method Methods 0.000 description 17
- 238000007920 subcutaneous administration Methods 0.000 description 17
- 230000008569 process Effects 0.000 description 14
- 239000000654 additive Substances 0.000 description 13
- 238000007918 intramuscular administration Methods 0.000 description 13
- 230000006920 protein precipitation Effects 0.000 description 12
- 238000010586 diagram Methods 0.000 description 10
- 239000000463 material Substances 0.000 description 9
- 239000012460 protein solution Substances 0.000 description 9
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 8
- 230000008901 benefit Effects 0.000 description 8
- 230000007774 longterm Effects 0.000 description 8
- 229920005862 polyol Polymers 0.000 description 8
- 150000003077 polyols Chemical class 0.000 description 8
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 7
- 229930195725 Mannitol Natural products 0.000 description 7
- 238000007792 addition Methods 0.000 description 7
- 230000008859 change Effects 0.000 description 7
- 239000000594 mannitol Substances 0.000 description 7
- 235000010355 mannitol Nutrition 0.000 description 7
- -1 polyoxyethylene Polymers 0.000 description 7
- 235000008504 concentrate Nutrition 0.000 description 6
- 239000012897 dilution medium Substances 0.000 description 6
- 230000000694 effects Effects 0.000 description 6
- 238000004108 freeze drying Methods 0.000 description 6
- 239000000543 intermediate Substances 0.000 description 6
- 238000006384 oligomerization reaction Methods 0.000 description 6
- 229920000136 polysorbate Polymers 0.000 description 6
- 230000001225 therapeutic effect Effects 0.000 description 6
- 230000007704 transition Effects 0.000 description 6
- 108060003951 Immunoglobulin Proteins 0.000 description 5
- 241000283973 Oryctolagus cuniculus Species 0.000 description 5
- 229920002359 Tetronic® Polymers 0.000 description 5
- 230000000996 additive effect Effects 0.000 description 5
- 230000015572 biosynthetic process Effects 0.000 description 5
- 238000005119 centrifugation Methods 0.000 description 5
- 102000018358 immunoglobulin Human genes 0.000 description 5
- 229940092253 ovalbumin Drugs 0.000 description 5
- 239000006228 supernatant Substances 0.000 description 5
- 239000012736 aqueous medium Substances 0.000 description 4
- 230000009286 beneficial effect Effects 0.000 description 4
- 239000013020 final formulation Substances 0.000 description 4
- 239000012530 fluid Substances 0.000 description 4
- 238000001879 gelation Methods 0.000 description 4
- 239000008188 pellet Substances 0.000 description 4
- 229920001451 polypropylene glycol Polymers 0.000 description 4
- 230000002829 reductive effect Effects 0.000 description 4
- 239000007787 solid Substances 0.000 description 4
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 description 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 3
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 3
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 description 3
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 description 3
- 230000015556 catabolic process Effects 0.000 description 3
- 239000000470 constituent Substances 0.000 description 3
- 238000006731 degradation reaction Methods 0.000 description 3
- 230000000717 retained effect Effects 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- 235000000346 sugar Nutrition 0.000 description 3
- 150000008163 sugars Chemical class 0.000 description 3
- 239000000725 suspension Substances 0.000 description 3
- 238000011282 treatment Methods 0.000 description 3
- 241000283690 Bos taurus Species 0.000 description 2
- 229920003171 Poly (ethylene oxide) Polymers 0.000 description 2
- PXIPVTKHYLBLMZ-UHFFFAOYSA-N Sodium azide Chemical compound [Na+].[N-]=[N+]=[N-] PXIPVTKHYLBLMZ-UHFFFAOYSA-N 0.000 description 2
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 description 2
- 229930006000 Sucrose Natural products 0.000 description 2
- 238000004458 analytical method Methods 0.000 description 2
- 229920001577 copolymer Polymers 0.000 description 2
- 238000010908 decantation Methods 0.000 description 2
- 230000003247 decreasing effect Effects 0.000 description 2
- 238000004925 denaturation Methods 0.000 description 2
- 230000036425 denaturation Effects 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 238000000855 fermentation Methods 0.000 description 2
- 230000004151 fermentation Effects 0.000 description 2
- 230000006870 function Effects 0.000 description 2
- 239000012456 homogeneous solution Substances 0.000 description 2
- 229940072221 immunoglobulins Drugs 0.000 description 2
- 230000006872 improvement Effects 0.000 description 2
- 238000001802 infusion Methods 0.000 description 2
- 239000007927 intramuscular injection Substances 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 239000000825 pharmaceutical preparation Substances 0.000 description 2
- 229940127557 pharmaceutical product Drugs 0.000 description 2
- 229950008882 polysorbate Drugs 0.000 description 2
- 230000017854 proteolysis Effects 0.000 description 2
- 238000000746 purification Methods 0.000 description 2
- 239000011780 sodium chloride Substances 0.000 description 2
- 239000007790 solid phase Substances 0.000 description 2
- 238000003756 stirring Methods 0.000 description 2
- 239000011550 stock solution Substances 0.000 description 2
- 239000005720 sucrose Substances 0.000 description 2
- 229940124597 therapeutic agent Drugs 0.000 description 2
- JIAARYAFYJHUJI-UHFFFAOYSA-L zinc dichloride Chemical compound [Cl-].[Cl-].[Zn+2] JIAARYAFYJHUJI-UHFFFAOYSA-L 0.000 description 2
- JNYAEWCLZODPBN-JGWLITMVSA-N (2r,3r,4s)-2-[(1r)-1,2-dihydroxyethyl]oxolane-3,4-diol Chemical class OC[C@@H](O)[C@H]1OC[C@H](O)[C@H]1O JNYAEWCLZODPBN-JGWLITMVSA-N 0.000 description 1
- VZSRBBMJRBPUNF-UHFFFAOYSA-N 2-(2,3-dihydro-1H-inden-2-ylamino)-N-[3-oxo-3-(2,4,6,7-tetrahydrotriazolo[4,5-c]pyridin-5-yl)propyl]pyrimidine-5-carboxamide Chemical compound C1C(CC2=CC=CC=C12)NC1=NC=C(C=N1)C(=O)NCCC(N1CC2=C(CC1)NN=N2)=O VZSRBBMJRBPUNF-UHFFFAOYSA-N 0.000 description 1
- 238000002965 ELISA Methods 0.000 description 1
- 229920000896 Ethulose Polymers 0.000 description 1
- 239000001859 Ethyl hydroxyethyl cellulose Substances 0.000 description 1
- IAYPIBMASNFSPL-UHFFFAOYSA-N Ethylene oxide Chemical compound C1CO1 IAYPIBMASNFSPL-UHFFFAOYSA-N 0.000 description 1
- PIICEJLVQHRZGT-UHFFFAOYSA-N Ethylenediamine Chemical compound NCCN PIICEJLVQHRZGT-UHFFFAOYSA-N 0.000 description 1
- RFSUNEUAIZKAJO-ARQDHWQXSA-N Fructose Chemical compound OC[C@H]1O[C@](O)(CO)[C@@H](O)[C@@H]1O RFSUNEUAIZKAJO-ARQDHWQXSA-N 0.000 description 1
- 229930091371 Fructose Natural products 0.000 description 1
- 239000005715 Fructose Substances 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- 208000031220 Hemophilia Diseases 0.000 description 1
- 208000009292 Hemophilia A Diseases 0.000 description 1
- 102000008394 Immunoglobulin Fragments Human genes 0.000 description 1
- 108010021625 Immunoglobulin Fragments Proteins 0.000 description 1
- 241000124008 Mammalia Species 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- 241001077660 Molo Species 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 description 1
- 229920002582 Polyethylene Glycol 600 Polymers 0.000 description 1
- 239000002202 Polyethylene glycol Substances 0.000 description 1
- GOOHAUXETOMSMM-UHFFFAOYSA-N Propylene oxide Chemical compound CC1CO1 GOOHAUXETOMSMM-UHFFFAOYSA-N 0.000 description 1
- 229940096437 Protein S Drugs 0.000 description 1
- VMHLLURERBWHNL-UHFFFAOYSA-M Sodium acetate Chemical compound [Na+].CC([O-])=O VMHLLURERBWHNL-UHFFFAOYSA-M 0.000 description 1
- 239000013543 active substance Substances 0.000 description 1
- 238000013019 agitation Methods 0.000 description 1
- BFNBIHQBYMNNAN-UHFFFAOYSA-N ammonium sulfate Chemical compound N.N.OS(O)(=O)=O BFNBIHQBYMNNAN-UHFFFAOYSA-N 0.000 description 1
- 229910052921 ammonium sulfate Inorganic materials 0.000 description 1
- 235000011130 ammonium sulphate Nutrition 0.000 description 1
- 230000002421 anti-septic effect Effects 0.000 description 1
- 206010003246 arthritis Diseases 0.000 description 1
- 230000008827 biological function Effects 0.000 description 1
- 230000036760 body temperature Effects 0.000 description 1
- 201000011510 cancer Diseases 0.000 description 1
- 239000013043 chemical agent Substances 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 238000011109 contamination Methods 0.000 description 1
- 238000001816 cooling Methods 0.000 description 1
- 102000003675 cytokine receptors Human genes 0.000 description 1
- 108010057085 cytokine receptors Proteins 0.000 description 1
- 239000008367 deionised water Substances 0.000 description 1
- 229910021641 deionized water Inorganic materials 0.000 description 1
- 239000008121 dextrose Substances 0.000 description 1
- 238000011026 diafiltration Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 235000019441 ethanol Nutrition 0.000 description 1
- 235000019326 ethyl hydroxyethyl cellulose Nutrition 0.000 description 1
- 238000001125 extrusion Methods 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 230000009969 flowable effect Effects 0.000 description 1
- 238000005187 foaming Methods 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 239000003102 growth factor Substances 0.000 description 1
- 230000009931 harmful effect Effects 0.000 description 1
- 230000002209 hydrophobic effect Effects 0.000 description 1
- 125000002887 hydroxy group Chemical group [H]O* 0.000 description 1
- 230000005847 immunogenicity Effects 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 239000007972 injectable composition Substances 0.000 description 1
- 239000013067 intermediate product Substances 0.000 description 1
- 238000012432 intermediate storage Methods 0.000 description 1
- 230000002427 irreversible effect Effects 0.000 description 1
- 239000007791 liquid phase Substances 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 230000000737 periodic effect Effects 0.000 description 1
- 229920001992 poloxamer 407 Polymers 0.000 description 1
- 229940044476 poloxamer 407 Drugs 0.000 description 1
- 229920001693 poly(ether-ester) Polymers 0.000 description 1
- 229920000570 polyether Polymers 0.000 description 1
- 229920001223 polyethylene glycol Polymers 0.000 description 1
- 229920002503 polyoxyethylene-polyoxypropylene Polymers 0.000 description 1
- 229940068965 polysorbates Drugs 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 238000005057 refrigeration Methods 0.000 description 1
- 238000001542 size-exclusion chromatography Methods 0.000 description 1
- 235000017281 sodium acetate Nutrition 0.000 description 1
- 239000001632 sodium acetate Substances 0.000 description 1
- 235000020354 squash Nutrition 0.000 description 1
- 230000010512 thermal transition Effects 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- 150000003751 zinc Chemical class 0.000 description 1
- 235000005074 zinc chloride Nutrition 0.000 description 1
- 239000011592 zinc chloride Substances 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K49/00—Preparations for testing in vivo
- A61K49/06—Nuclear magnetic resonance [NMR] contrast preparations; Magnetic resonance imaging [MRI] contrast preparations
- A61K49/08—Nuclear magnetic resonance [NMR] contrast preparations; Magnetic resonance imaging [MRI] contrast preparations characterised by the carrier
- A61K49/10—Organic compounds
- A61K49/14—Peptides, e.g. proteins
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39591—Stabilisation, fragmentation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Immunology (AREA)
- Rheumatology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Dermatology (AREA)
- Radiology & Medical Imaging (AREA)
- Pain & Pain Management (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Physical Education & Sports Medicine (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US33021301P | 2001-10-16 | 2001-10-16 | |
| PCT/US2002/032872 WO2003032907A2 (en) | 2001-10-16 | 2002-10-16 | High-concentration protein formulations and method of manufacture |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| MXPA04003640A true MXPA04003640A (es) | 2005-04-11 |
Family
ID=23288780
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MXPA04003640A MXPA04003640A (es) | 2001-10-16 | 2002-10-16 | Formulaciones de proteina de alta concentracion y metodo de fabricacion. |
Country Status (8)
| Country | Link |
|---|---|
| US (1) | US8372798B2 (https=) |
| EP (1) | EP1441748A4 (https=) |
| JP (1) | JP2005523882A (https=) |
| CN (1) | CN1604788B (https=) |
| AU (1) | AU2002335815A1 (https=) |
| BR (1) | BR0213298A (https=) |
| MX (1) | MXPA04003640A (https=) |
| WO (1) | WO2003032907A2 (https=) |
Families Citing this family (20)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8703126B2 (en) | 2000-10-12 | 2014-04-22 | Genentech, Inc. | Reduced-viscosity concentrated protein formulations |
| AU2002213441B2 (en) | 2000-10-12 | 2006-10-26 | Genentech, Inc. | Reduced-viscosity concentrated protein formulations |
| US20050158303A1 (en) * | 2003-04-04 | 2005-07-21 | Genentech, Inc. | Methods of treating IgE-mediated disorders comprising the administration of high concentration anti-IgE antibody formulations |
| CN1798575A (zh) | 2003-04-04 | 2006-07-05 | 健泰科生物技术公司 | 高浓度抗体和蛋白制剂 |
| JP2007538048A (ja) * | 2004-05-17 | 2007-12-27 | アレス トレーディング ソシエテ アノニム | ヒドロゲル・インターフェロン製剤 |
| EP2044934A1 (en) * | 2007-10-01 | 2009-04-08 | Institut National De La Sante Et De La Recherche Medicale (Inserm) | Dispersion of poloxamer-protein particles, methods of manufacturing and uses thereof |
| AR076640A1 (es) * | 2009-03-06 | 2011-06-29 | Genentech Inc | Formulacion con anticuerpo. metodo para estabilizar anticuerpo. articulo de manufactura |
| HUE047173T2 (hu) | 2010-03-01 | 2020-04-28 | Bayer Healthcare Llc | Optimalizált monoklonális ellenanyagok szöveti faktor útvonal inhibitor (TFPI) ellen |
| KR20200032244A (ko) * | 2012-03-07 | 2020-03-25 | 아미쿠스 세라퓨틱스, 인코포레이티드 | 폼페병의 치료를 위한 고농도 알파-글루코시다제 조성물 |
| US9592297B2 (en) | 2012-08-31 | 2017-03-14 | Bayer Healthcare Llc | Antibody and protein formulations |
| US8613919B1 (en) | 2012-08-31 | 2013-12-24 | Bayer Healthcare, Llc | High concentration antibody and protein formulations |
| WO2015196091A1 (en) | 2014-06-20 | 2015-12-23 | Reform Biologics, Llc | Viscosity-reducing excipient compounds for protein formulations |
| US10478498B2 (en) | 2014-06-20 | 2019-11-19 | Reform Biologics, Llc | Excipient compounds for biopolymer formulations |
| US11357857B2 (en) | 2014-06-20 | 2022-06-14 | Comera Life Sciences, Inc. | Excipient compounds for protein processing |
| WO2016054231A1 (en) | 2014-09-30 | 2016-04-07 | Amicus Therapeutics, Inc. | Highly potent acid alpha-glucosidase with enhanced carbohydrates |
| KR102510941B1 (ko) | 2015-12-30 | 2023-03-20 | 아미쿠스 세라퓨틱스, 인코포레이티드 | 폼페병 치료용의 강화된 산 알파-글루코시다제 |
| US10227577B2 (en) | 2016-03-30 | 2019-03-12 | Amicus Therapeutics, Inc. | Method for selection of high M6P recombinant proteins |
| IL325155A (en) | 2016-03-30 | 2026-02-01 | Amicus Therapeutics Inc | Formulations containing recombinant acid alpha-glucosidase |
| EP3624831B1 (en) | 2017-05-15 | 2023-03-29 | Amicus Therapeutics, Inc. | Recombinant human acid alpha-glucosidase |
| WO2021042090A2 (en) * | 2020-11-27 | 2021-03-04 | Schott Ag | System for long time storage of pharmaceutical compositions at low temperatures |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AT359641B (de) * | 1978-09-19 | 1980-11-25 | Immuno Ag | Verfahren zur herstellung eines intravenoes ver- abreichbaren antikoerperhaeltigen immunglobulin- praeparates |
| PT682524E (pt) * | 1993-02-02 | 2002-03-28 | Xoma Technology Ltd | Composicoes farmaceuticas que contem a proteina bactericida indutora da permeabilidade e um agente tensioactivo |
| US5861158A (en) * | 1993-11-17 | 1999-01-19 | The United States Of America As Represented By The Deptartment Of Health And Human Services | Method and composition for transfer of active tumor-specific immunization from an immunized allogeneic bone marrow donor |
| AU692506B2 (en) * | 1993-11-17 | 1998-06-11 | Ibah, Inc. | Transparent liquid for encapsulated drug delivery |
| US6267958B1 (en) * | 1995-07-27 | 2001-07-31 | Genentech, Inc. | Protein formulation |
| US5702717A (en) * | 1995-10-25 | 1997-12-30 | Macromed, Inc. | Thermosensitive biodegradable polymers based on poly(ether-ester)block copolymers |
| US20050019325A1 (en) * | 1996-01-08 | 2005-01-27 | Carter Paul J. | WSX receptor agonist antibodies |
| US5861174A (en) * | 1996-07-12 | 1999-01-19 | University Technology Corporation | Temperature sensitive gel for sustained delivery of protein drugs |
| US6228360B1 (en) * | 1998-08-19 | 2001-05-08 | Ajinomoto Co., Inc. | Antithrombotic agent and humanized anti-von Willebrand factor monoclonal antibody |
| BR0111948A (pt) * | 2000-06-26 | 2004-08-24 | Rxkinetix Inc | Composição para entrega de fator de crescimento hematopoiético |
| US6613907B2 (en) * | 2000-11-08 | 2003-09-02 | Amr Technology, Inc. | Process for the production of piperidine derivatives with microorganisms |
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2002
- 2002-10-16 CN CN028251857A patent/CN1604788B/zh not_active Expired - Fee Related
- 2002-10-16 EP EP02770580A patent/EP1441748A4/en not_active Withdrawn
- 2002-10-16 WO PCT/US2002/032872 patent/WO2003032907A2/en not_active Ceased
- 2002-10-16 AU AU2002335815A patent/AU2002335815A1/en not_active Abandoned
- 2002-10-16 MX MXPA04003640A patent/MXPA04003640A/es active IP Right Grant
- 2002-10-16 US US10/271,832 patent/US8372798B2/en not_active Expired - Fee Related
- 2002-10-16 BR BRPI0213298-2A patent/BR0213298A/pt not_active Application Discontinuation
- 2002-10-16 JP JP2003535713A patent/JP2005523882A/ja active Pending
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|---|---|
| AU2002335815A1 (en) | 2003-04-28 |
| US8372798B2 (en) | 2013-02-12 |
| EP1441748A4 (en) | 2007-07-11 |
| CN1604788A (zh) | 2005-04-06 |
| WO2003032907A2 (en) | 2003-04-24 |
| BR0213298A (pt) | 2006-11-07 |
| US20030092607A1 (en) | 2003-05-15 |
| WO2003032907A3 (en) | 2004-02-19 |
| CN1604788B (zh) | 2013-04-17 |
| JP2005523882A (ja) | 2005-08-11 |
| WO2003032907A9 (en) | 2005-01-06 |
| EP1441748A2 (en) | 2004-08-04 |
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