SG11202100028PA - METHOD FOR THE PRODUCTION OF FREEZE-DRIED PELLETS COMPRISING AN ANTI-COAGULATION FACTOR XIa (FXIa) ANTIBODY - Google Patents
METHOD FOR THE PRODUCTION OF FREEZE-DRIED PELLETS COMPRISING AN ANTI-COAGULATION FACTOR XIa (FXIa) ANTIBODYInfo
- Publication number
- SG11202100028PA SG11202100028PA SG11202100028PA SG11202100028PA SG11202100028PA SG 11202100028P A SG11202100028P A SG 11202100028PA SG 11202100028P A SG11202100028P A SG 11202100028PA SG 11202100028P A SG11202100028P A SG 11202100028PA SG 11202100028P A SG11202100028P A SG 11202100028PA
- Authority
- SG
- Singapore
- Prior art keywords
- fxia
- freeze
- antibody
- production
- coagulation factor
- Prior art date
Links
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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1682—Processes
- A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/36—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against blood coagulation factors
-
- 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
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
-
- 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
- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- 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
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- 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
-
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
-
- 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
- A61K9/08—Solutions
-
- 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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
-
- 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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
-
- 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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- 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
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B5/00—Drying solid materials or objects by processes not involving the application of heat
- F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
- F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
- F26B5/065—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing the product to be freeze-dried being sprayed, dispersed or pulverised
-
- 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
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Molecular Biology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biophysics (AREA)
- Organic Chemistry (AREA)
- Immunology (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Hematology (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Mechanical Engineering (AREA)
- Dermatology (AREA)
- General Engineering & Computer Science (AREA)
- Diabetes (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Endocrinology (AREA)
- Genetics & Genomics (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Glanulating (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Drying Of Solid Materials (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP2018068250 | 2018-07-05 | ||
| PCT/EP2019/068071 WO2020008022A1 (en) | 2018-07-05 | 2019-07-05 | METHOD FOR THE PRODUCTION OF FREEZE-DRIED PELLETS COMPRISING AN ANTI-COAGULATION FACTOR XIa (FXIa) ANTIBODY |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| SG11202100028PA true SG11202100028PA (en) | 2021-01-28 |
Family
ID=67139764
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SG11202100046UA SG11202100046UA (en) | 2018-07-05 | 2019-07-05 | NOVEL STABLE HIGH-CONCENTRATION FORMULATION FOR ANTI-FXIa ANTIBODIES |
| SG11202100028PA SG11202100028PA (en) | 2018-07-05 | 2019-07-05 | METHOD FOR THE PRODUCTION OF FREEZE-DRIED PELLETS COMPRISING AN ANTI-COAGULATION FACTOR XIa (FXIa) ANTIBODY |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SG11202100046UA SG11202100046UA (en) | 2018-07-05 | 2019-07-05 | NOVEL STABLE HIGH-CONCENTRATION FORMULATION FOR ANTI-FXIa ANTIBODIES |
Country Status (16)
| Country | Link |
|---|---|
| US (2) | US20210290534A1 (de) |
| EP (2) | EP3817727A1 (de) |
| JP (2) | JP2021529800A (de) |
| KR (2) | KR20210029221A (de) |
| CN (2) | CN112543627A (de) |
| AR (1) | AR115713A1 (de) |
| AU (2) | AU2019298656A1 (de) |
| BR (2) | BR112020026789A2 (de) |
| CA (2) | CA3105261A1 (de) |
| IL (2) | IL279865A (de) |
| MX (2) | MX2021000037A (de) |
| PE (2) | PE20210779A1 (de) |
| SA (1) | SA521420957B1 (de) |
| SG (2) | SG11202100046UA (de) |
| TW (1) | TW202034898A (de) |
| WO (2) | WO2020008022A1 (de) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA3105261A1 (en) * | 2018-07-05 | 2020-01-09 | Bayer Aktiengesellschaft | Method for the production of freeze-dried pellets comprising an anti-coagulation factor xia (fxia) antibody |
| WO2022122993A1 (en) * | 2020-12-11 | 2022-06-16 | Boehringer Ingelheim International Gmbh | Formulation for multi-purpose application |
Family Cites Families (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP4436457B2 (ja) | 1995-08-18 | 2010-03-24 | モルフォシス アイピー ゲーエムベーハー | 蛋白質／（ポリ）ペプチドライブラリー |
| US8703126B2 (en) | 2000-10-12 | 2014-04-22 | Genentech, Inc. | Reduced-viscosity concentrated protein formulations |
| ATE542095T1 (de) | 2004-07-23 | 2012-02-15 | Bayer Technology Services Gmbh | Verfahren zum sterilen gefrieren, trocknen, lagern, analysieren und füllen (sfd-saf- verfahren) (verfahren zur gefriertrocknung von granulat für parenterale biopharmazeutika) |
| ES2750254T3 (es) | 2007-09-27 | 2020-03-25 | Amgen Inc | Formulaciones farmacéuticas |
| EP2578974A1 (de) | 2011-10-05 | 2013-04-10 | Sanofi Pasteur Sa | Verfahrenslinie zur Herstellung von gefriergetrockneten Partikeln |
| EP2578975A1 (de) | 2011-10-05 | 2013-04-10 | Sanofi Pasteur Sa | Drehtrommel Gefriertrockner |
| WO2013167669A1 (en) * | 2012-05-10 | 2013-11-14 | Bayer Pharma Aktiengesellschaft | Antibodies capable of binding to the coagulation factor xi and/or its activated form factor xia and uses thereof |
| US9592297B2 (en) * | 2012-08-31 | 2017-03-14 | Bayer Healthcare Llc | Antibody and protein formulations |
| BR112015008186A2 (pt) | 2012-10-25 | 2017-09-19 | Medimmune Llc | formulação de um anticorpo estável e de baixa viscosidade |
| KR102534017B1 (ko) | 2014-10-23 | 2023-05-19 | 암젠 인크 | 약제학적 제형의 점도 감소 |
| EP3167877A1 (de) * | 2015-11-12 | 2017-05-17 | Bayer Pharma Aktiengesellschaft | Verfahren zur herstellung von gefriergetrockneten pellets mit faktor viii |
| JP2019511531A (ja) * | 2016-04-13 | 2019-04-25 | メディミューン，エルエルシー | 高濃度のタンパク質ベース治療薬を含有する医薬組成物における安定化化合物としてのアミノ酸の使用 |
| EP3254671B1 (de) * | 2016-06-10 | 2019-11-13 | Octapharma AG | Hochkonzentrierte immunglobulinzusammensetzung zur pharmazeutischen anwendung |
| IL308980A (en) * | 2016-12-23 | 2024-01-01 | Novartis Ag | Antibodies against factor XI and methods of their use |
| CA3105261A1 (en) * | 2018-07-05 | 2020-01-09 | Bayer Aktiengesellschaft | Method for the production of freeze-dried pellets comprising an anti-coagulation factor xia (fxia) antibody |
-
2019
- 2019-07-05 CA CA3105261A patent/CA3105261A1/en not_active Abandoned
- 2019-07-05 MX MX2021000037A patent/MX2021000037A/es unknown
- 2019-07-05 WO PCT/EP2019/068071 patent/WO2020008022A1/en active Application Filing
- 2019-07-05 CA CA3105256A patent/CA3105256A1/en active Pending
- 2019-07-05 JP JP2021500069A patent/JP2021529800A/ja active Pending
- 2019-07-05 EP EP19735335.2A patent/EP3817727A1/de not_active Withdrawn
- 2019-07-05 AR ARP190101919A patent/AR115713A1/es unknown
- 2019-07-05 CN CN201980050959.7A patent/CN112543627A/zh active Pending
- 2019-07-05 AU AU2019298656A patent/AU2019298656A1/en active Pending
- 2019-07-05 CN CN201980044750.XA patent/CN112367975A/zh active Pending
- 2019-07-05 KR KR1020217003292A patent/KR20210029221A/ko unknown
- 2019-07-05 JP JP2021500070A patent/JP2021529801A/ja active Pending
- 2019-07-05 US US17/257,827 patent/US20210290534A1/en not_active Abandoned
- 2019-07-05 TW TW108123732A patent/TW202034898A/zh unknown
- 2019-07-05 AU AU2019297498A patent/AU2019297498A1/en not_active Abandoned
- 2019-07-05 EP EP19735338.6A patent/EP3817723A1/de active Pending
- 2019-07-05 PE PE2020002228A patent/PE20210779A1/es unknown
- 2019-07-05 MX MX2021000028A patent/MX2021000028A/es unknown
- 2019-07-05 SG SG11202100046UA patent/SG11202100046UA/en unknown
- 2019-07-05 WO PCT/EP2019/068106 patent/WO2020008035A1/en active Application Filing
- 2019-07-05 SG SG11202100028PA patent/SG11202100028PA/en unknown
- 2019-07-05 PE PE2020002238A patent/PE20210462A1/es unknown
- 2019-07-05 BR BR112020026789-9A patent/BR112020026789A2/pt unknown
- 2019-07-05 US US17/257,828 patent/US20210292434A1/en active Pending
- 2019-07-05 KR KR1020217003293A patent/KR20210028673A/ko active Search and Examination
- 2019-07-05 BR BR112020026492-0A patent/BR112020026492A2/pt not_active Application Discontinuation
-
2020
- 2020-12-30 IL IL279865A patent/IL279865A/en unknown
- 2020-12-30 IL IL279868A patent/IL279868A/en unknown
-
2021
- 2021-01-03 SA SA521420957A patent/SA521420957B1/ar unknown
Also Published As
| Publication number | Publication date |
|---|---|
| CN112543627A (zh) | 2021-03-23 |
| JP2021529800A (ja) | 2021-11-04 |
| US20210292434A1 (en) | 2021-09-23 |
| PE20210462A1 (es) | 2021-03-08 |
| MX2021000028A (es) | 2021-03-09 |
| JP2021529801A (ja) | 2021-11-04 |
| AU2019298656A1 (en) | 2021-01-28 |
| CA3105261A1 (en) | 2020-01-09 |
| TW202034898A (zh) | 2020-10-01 |
| BR112020026492A2 (pt) | 2021-04-06 |
| IL279868A (en) | 2021-03-01 |
| MX2021000037A (es) | 2021-03-25 |
| WO2020008035A1 (en) | 2020-01-09 |
| US20210290534A1 (en) | 2021-09-23 |
| IL279865A (en) | 2021-03-01 |
| CN112367975A (zh) | 2021-02-12 |
| EP3817727A1 (de) | 2021-05-12 |
| PE20210779A1 (es) | 2021-04-21 |
| EP3817723A1 (de) | 2021-05-12 |
| SA521420957B1 (ar) | 2023-12-14 |
| WO2020008022A1 (en) | 2020-01-09 |
| CA3105256A1 (en) | 2020-01-09 |
| AU2019297498A1 (en) | 2021-01-21 |
| KR20210029221A (ko) | 2021-03-15 |
| BR112020026789A2 (pt) | 2021-03-30 |
| AR115713A1 (es) | 2021-02-17 |
| SG11202100046UA (en) | 2021-02-25 |
| KR20210028673A (ko) | 2021-03-12 |
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