CA2794864A1 - Compositions and methods useful for reducing the viscosity of protein-containing formulations - Google Patents
Compositions and methods useful for reducing the viscosity of protein-containing formulations Download PDFInfo
- Publication number
- CA2794864A1 CA2794864A1 CA 2794864 CA2794864A CA2794864A1 CA 2794864 A1 CA2794864 A1 CA 2794864A1 CA 2794864 CA2794864 CA 2794864 CA 2794864 A CA2794864 A CA 2794864A CA 2794864 A1 CA2794864 A1 CA 2794864A1
- Authority
- CA
- Canada
- Prior art keywords
- antibody
- protein
- viscosity
- arginine
- formulation
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- 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
-
- 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
- A61K47/16—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
-
- 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
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2803—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
- C07K16/2812—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against CD4
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Immunology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US33068910P | 2010-05-03 | 2010-05-03 | |
| US61/330,689 | 2010-05-03 | ||
| PCT/US2011/034001 WO2011139718A1 (en) | 2010-05-03 | 2011-04-26 | Compositions and methods useful for reducing the viscosity of protein-containing formulations |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2794864A1 true CA2794864A1 (en) | 2011-11-10 |
Family
ID=44263176
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA 2794864 Pending CA2794864A1 (en) | 2010-05-03 | 2011-04-26 | Compositions and methods useful for reducing the viscosity of protein-containing formulations |
Country Status (10)
| Country | Link |
|---|---|
| US (1) | US20130058958A1 (https=) |
| EP (1) | EP2566510A1 (https=) |
| JP (1) | JP2013525484A (https=) |
| KR (1) | KR20130060227A (https=) |
| CN (1) | CN102958538A (https=) |
| BR (1) | BR112012027828A2 (https=) |
| CA (1) | CA2794864A1 (https=) |
| MX (1) | MX2012012743A (https=) |
| RU (1) | RU2012151500A (https=) |
| WO (1) | WO2011139718A1 (https=) |
Families Citing this family (46)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2832560A1 (en) * | 2011-04-07 | 2012-10-18 | Glaxosmithkline Llc | Formulations with reduced viscosity |
| US9574005B2 (en) | 2011-07-19 | 2017-02-21 | Chugai Seiyaku Kabushiki Kaisha | Stable Protein-containing preparation containing argininamide or analogous compound thereof |
| RU2665810C2 (ru) | 2011-10-31 | 2018-09-04 | Дженентек, Инк. | Содержащие антитела составы |
| US9169304B2 (en) | 2012-05-01 | 2015-10-27 | Pfenex Inc. | Process for purifying recombinant Plasmodium falciparum circumsporozoite protein |
| PE20150190A1 (es) * | 2012-06-21 | 2015-02-13 | Ucb Pharma Sa | Formulacion farmaceutica |
| LT3495387T (lt) | 2012-07-13 | 2021-11-25 | Roche Glycart Ag | Bispecifiniai anti-vegf / anti-ang-2 antikūnai ir jų panaudojimas akių kraujagyslių ligoms gydyti |
| FR2994390B1 (fr) | 2012-08-10 | 2014-08-15 | Adocia | Procede d'abaissement de la viscosite de solutions de proteines a concentration elevee |
| FR2995214B1 (fr) | 2012-09-10 | 2014-11-21 | Adocia | Solution a viscosite reduite de proteine a concentration elevee |
| UA117466C2 (uk) | 2012-12-13 | 2018-08-10 | Мерк Шарп Енд Доме Корп. | СТАБІЛЬНИЙ СКЛАД У ВИГЛЯДІ РОЗЧИНУ АНТИТІЛА ДО IL-23p19 |
| JP6179939B2 (ja) * | 2013-07-09 | 2017-08-16 | 国立大学法人 筑波大学 | 高濃度γグロブリン製剤の粘度低下方法 |
| IL312865B2 (en) | 2013-09-11 | 2025-06-01 | Eagle Biologics Inc | Liquid protein formulations containing viscosity-lowering agents |
| CN104740630A (zh) * | 2013-12-25 | 2015-07-01 | 浙江海正药业股份有限公司 | 一种含有抗cd52单抗的药物组合物 |
| 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 |
| WO2015196091A1 (en) | 2014-06-20 | 2015-12-23 | Reform Biologics, Llc | Viscosity-reducing excipient compounds for protein formulations |
| EP3200804A4 (en) | 2014-10-01 | 2018-04-18 | Eagle Biologics, Inc. | Polysaccharide and nucleic acid formulations containing viscosity-lowering agents |
| AU2015335743B2 (en) * | 2014-10-23 | 2020-12-24 | Amgen Inc. | Reducing viscosity of pharmaceutical formulations |
| AR103173A1 (es) | 2014-12-22 | 2017-04-19 | Novarits Ag | Productos farmacéuticos y composiciones líquidas estables de anticuerpos il-17 |
| MA41629A (fr) | 2015-03-04 | 2018-01-09 | Center For Human Reproduction | Compositions et méthodes d'utilisation de l'hormone anti-müllérienne pour le traitement de l'infertilité |
| US20170056352A1 (en) | 2015-08-25 | 2017-03-02 | Rgenix, Inc. | PHARMACEUTICALLY ACCEPTABLE SALTS OF beta-GUANIDINOPROPIONIC ACID WITH IMPROVED PROPERTIES AND USES THEREOF |
| JP2018535242A (ja) * | 2015-11-30 | 2018-11-29 | 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の治療剤を含有する医薬組成物中の非晶質安定化化合物としてのアミノ酸と糖との最適比 |
| JP7377596B2 (ja) | 2017-02-22 | 2023-11-10 | アムジエン・インコーポレーテツド | 低粘度、高濃度エボロクマブ製剤及びそれらの製造方法 |
| WO2018160178A1 (en) | 2017-03-01 | 2018-09-07 | Rgenix, Inc. | Pharmaceutically acceptable salts of b-guanidinopropionic acid with improved properties and uses thereof |
| MA48461A (fr) | 2017-04-28 | 2020-03-04 | Amgen Inc | Excipients pour réduire la viscosité de formulations d'anticorps et compositions de formulation |
| MA48464A (fr) * | 2017-04-28 | 2020-03-04 | Amgen Inc | Dipeptides n-acétylés et non acétylés contenant de l'arginine destinés à réduire la viscosité de compositions visqueuses de polypeptides thérapeutiques |
| AU2018263868A1 (en) | 2017-05-02 | 2019-12-12 | Merck Sharp & Dohme Llc | Formulations of anti-LAG3 antibodies and co-formulations of anti-LAG3 antibodies and anti-PD-1 antibodies |
| JOP20190260A1 (ar) | 2017-05-02 | 2019-10-31 | Merck Sharp & Dohme | صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها |
| CA3063324A1 (en) | 2017-05-16 | 2018-11-22 | Bhami's Research Laboratory, Pvt. Ltd. | High concentration protein formulations with reduced viscosity |
| WO2018213151A1 (en) * | 2017-05-18 | 2018-11-22 | Merck Sharp & Dohme Corp. | Pharmaceutical formulation comprising incretin-insulin conjugates |
| CA3074565A1 (en) | 2017-09-05 | 2019-03-14 | Merck Sharp & Dohme Corp. | Compounds for reducing the viscosity of biological formulations |
| AU2019254483B2 (en) * | 2018-04-16 | 2025-02-27 | Merck Patent Gmbh | Viscosity reduction of highly concentrated protein formulations |
| US11103552B2 (en) | 2018-05-10 | 2021-08-31 | Regeneron Pharmaceuticals, Inc. | High concentration VEGF receptor fusion protein containing formulations |
| KR102885113B1 (ko) | 2018-10-18 | 2025-11-13 | 머크 샤프 앤드 돔 엘엘씨 | 항-rsv 항체의 제제 및 그의 사용 방법 |
| CN120842406A (zh) | 2018-10-31 | 2025-10-28 | 默沙东有限责任公司 | 抗人pd-1抗体晶体及其使用方法 |
| CN113316458B (zh) | 2018-11-07 | 2024-08-02 | 默沙东有限责任公司 | 抗lag3抗体和抗pd-1抗体的共制剂 |
| GB201900728D0 (en) * | 2019-01-18 | 2019-03-06 | Univ Birmingham | Drug delivery system |
| CA3154653A1 (en) * | 2019-09-17 | 2021-03-25 | Merck Patent Gmbh | Camphorsulfonic acid and combinations thereof with cationic excipients as viscosity reducing agents in high concentrated protein formulations |
| JP2023505687A (ja) | 2019-12-11 | 2023-02-10 | インスピルナ,インコーポレーテッド | 癌の処置方法 |
| FI4045533T3 (fi) | 2020-03-26 | 2024-02-02 | Univ Vanderbilt | Ihmisen monoklonaalisia vasta-aineita vakavalle akuutille koronavirus 2 -hengityselinoireyhtymälle (sars-cov-2) |
| MX2023000557A (es) * | 2020-07-13 | 2023-02-13 | Merck Patent Gmbh | Excipientes reductores de la viscosidad y combinaciones de los mismos para formulaciones proteicas altamente concentradas. |
| EP4319795A4 (en) * | 2021-04-09 | 2025-03-05 | Avantor Performance Materials, LLC | Performance-enhancing excipients and methods of reducing viscosity and increasing stability of biologic formulations |
| JP2024542989A (ja) * | 2021-10-29 | 2024-11-19 | アスラン ファーマシューティカルズ ピーティーイー リミテッド | 抗il-13r抗体製剤 |
| WO2023075702A1 (en) * | 2021-10-29 | 2023-05-04 | Aslan Pharmaceuticals Pte Ltd | Anti-il-13r antibody formulation |
| TW202342095A (zh) * | 2021-11-05 | 2023-11-01 | 英商阿斯特捷利康英國股份有限公司 | 用於治療和預防covid—19之組成物 |
| TW202342510A (zh) | 2022-02-18 | 2023-11-01 | 英商Rq生物科技有限公司 | 抗體 |
| TW202527982A (zh) * | 2023-09-11 | 2025-07-16 | 美商默門塔醫藥公司 | Fcrn抗體之醫藥組成物 |
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-
2011
- 2011-04-26 KR KR20127031426A patent/KR20130060227A/ko not_active Withdrawn
- 2011-04-26 BR BR112012027828A patent/BR112012027828A2/pt not_active IP Right Cessation
- 2011-04-26 RU RU2012151500/15A patent/RU2012151500A/ru not_active Application Discontinuation
- 2011-04-26 EP EP20110720633 patent/EP2566510A1/en not_active Withdrawn
- 2011-04-26 CA CA 2794864 patent/CA2794864A1/en active Pending
- 2011-04-26 MX MX2012012743A patent/MX2012012743A/es not_active Application Discontinuation
- 2011-04-26 WO PCT/US2011/034001 patent/WO2011139718A1/en not_active Ceased
- 2011-04-26 JP JP2013509113A patent/JP2013525484A/ja active Pending
- 2011-04-26 CN CN2011800320023A patent/CN102958538A/zh active Pending
-
2012
- 2012-11-02 US US13/666,990 patent/US20130058958A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| MX2012012743A (es) | 2012-11-23 |
| BR112012027828A2 (pt) | 2016-08-09 |
| JP2013525484A (ja) | 2013-06-20 |
| RU2012151500A (ru) | 2014-06-10 |
| CN102958538A (zh) | 2013-03-06 |
| KR20130060227A (ko) | 2013-06-07 |
| WO2011139718A1 (en) | 2011-11-10 |
| US20130058958A1 (en) | 2013-03-07 |
| EP2566510A1 (en) | 2013-03-13 |
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