[go: up one dir, main page]

ZA9710409B - Stable lyophilised pharmaceutical preparations comprising mono- or polyclonal antibodies - Google Patents

Stable lyophilised pharmaceutical preparations comprising mono- or polyclonal antibodies

Info

Publication number
ZA9710409B
ZA9710409B ZA9710409A ZA9710409A ZA9710409B ZA 9710409 B ZA9710409 B ZA 9710409B ZA 9710409 A ZA9710409 A ZA 9710409A ZA 9710409 A ZA9710409 A ZA 9710409A ZA 9710409 B ZA9710409 B ZA 9710409B
Authority
ZA
South Africa
Prior art keywords
mono
polyclonal antibodies
pharmaceutical preparations
lyophilised pharmaceutical
stable lyophilised
Prior art date
Application number
ZA9710409A
Other languages
English (en)
Inventor
Gerhard Winter
Christian Klessen
Heinrich Woog
Georg Kallmeyer
Original Assignee
Roche Diagnostics Gmbh
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=8223412&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ZA9710409(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Roche Diagnostics Gmbh filed Critical Roche Diagnostics Gmbh
Publication of ZA9710409B publication Critical patent/ZA9710409B/xx

Links

Classifications

    • 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
    • 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
    • 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
    • A61K9/14—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
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/04—Immunostimulants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/08—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/081—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses from DNA viruses
    • C07K16/082—Hepadnaviridae, e.g. hepatitis B virus
    • 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
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2863—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for growth factors, growth regulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Virology (AREA)
  • Communicable Diseases (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
ZA9710409A 1996-11-19 1997-11-19 Stable lyophilised pharmaceutical preparations comprising mono- or polyclonal antibodies ZA9710409B (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP96118489A EP0852951A1 (de) 1996-11-19 1996-11-19 Stabile lyophilisierte pharmazeutische Zubereitungen von mono- oder polyklonalen Antikörpern

Publications (1)

Publication Number Publication Date
ZA9710409B true ZA9710409B (en) 1999-05-19

Family

ID=8223412

Family Applications (1)

Application Number Title Priority Date Filing Date
ZA9710409A ZA9710409B (en) 1996-11-19 1997-11-19 Stable lyophilised pharmaceutical preparations comprising mono- or polyclonal antibodies

Country Status (19)

Country Link
US (2) US8758747B2 (cs)
EP (2) EP0852951A1 (cs)
JP (2) JP4536829B2 (cs)
KR (1) KR100514207B1 (cs)
CN (1) CN1155408C (cs)
AR (2) AR012540A1 (cs)
AT (1) ATE276762T1 (cs)
AU (2) AU735411C (cs)
BR (1) BR9713521A (cs)
CA (1) CA2272245C (cs)
DE (1) DE59711959D1 (cs)
DK (1) DK0941121T3 (cs)
ES (1) ES2227727T3 (cs)
ID (1) ID19029A (cs)
PT (1) PT941121E (cs)
TR (1) TR199901696T2 (cs)
TW (1) TW520291B (cs)
WO (1) WO1998022136A2 (cs)
ZA (1) ZA9710409B (cs)

Families Citing this family (130)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6267958B1 (en) 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
US6685940B2 (en) 1995-07-27 2004-02-03 Genentech, Inc. Protein formulation
EP0852951A1 (de) * 1996-11-19 1998-07-15 Roche Diagnostics GmbH Stabile lyophilisierte pharmazeutische Zubereitungen von mono- oder polyklonalen Antikörpern
EP0917879B1 (de) * 1997-11-22 2002-07-17 Boehringer Mannheim Gmbh Verbessertes Verfahren zur Stabilisierung von Proteinen
CA2371427A1 (en) * 1999-04-28 2000-11-09 Yamanouchi Pharmaceutical Co., Ltd. Parenteral pharmaceutical composition containing humanized monoclonal antibody fragment and stabilizing method thereof
EP1314437B1 (en) * 2000-08-11 2014-06-25 Chugai Seiyaku Kabushiki Kaisha Stabilized antibody-containing preparations
US7138262B1 (en) 2000-08-18 2006-11-21 Shire Human Genetic Therapies, Inc. High mannose proteins and methods of making high mannose proteins
US8703126B2 (en) 2000-10-12 2014-04-22 Genentech, Inc. Reduced-viscosity concentrated protein formulations
TWI232102B (en) 2001-07-17 2005-05-11 Shionogi & Co A pharmaceutical formulation for injection
ATE414537T1 (de) * 2001-08-29 2008-12-15 Chugai Pharmaceutical Co Ltd Antikörper enthaltende stabilisierte zubereitungen
NZ532896A (en) 2001-11-08 2007-08-31 Pdl Biopharma Inc Stable liquid pharmaceutical formulation of IGG antibodies including daclizumab and fontolizumab
DE10163459A1 (de) * 2001-12-21 2003-07-03 Merck Patent Gmbh Lyophilisierte Zubereitung enthaltend Antikörper gegen EGF-Rezeptor
DE10204792A1 (de) * 2002-02-06 2003-08-14 Merck Patent Gmbh Lyophilisierte Zubereitung enthaltend Immuncytokine
PL213311B1 (pl) 2002-02-14 2013-02-28 Chugai Pharmaceutical Co Ltd Preparat roztworu zawierajacego przeciwcialo
PT1946776T (pt) 2002-02-27 2017-03-17 Immunex Corp Composição de tnfr-fc estabilizada compreendendo arginina
US20040033228A1 (en) 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
JP5057648B2 (ja) * 2002-09-26 2012-10-24 塩野義製薬株式会社 安定化されたタンパク組成物
JPWO2004033499A1 (ja) 2002-10-11 2006-02-09 中外製薬株式会社 細胞死誘導剤
WO2004071439A2 (en) * 2003-02-10 2004-08-26 Elan Pharmaceuticals, Inc. Immunoglobulin formulation and method of preparation thereof
KR101235507B1 (ko) * 2003-02-28 2013-02-20 추가이 세이야쿠 가부시키가이샤 단백질을 함유하는 안정화 제제
PL1610820T5 (pl) 2003-04-04 2014-01-31 Genentech Inc Preparaty zawierające wysokoskoncentrowane przeciwciała i białka
SI1684719T1 (sl) * 2003-11-14 2012-07-31 Baxter Int Sestavki alfa antitripsina in postopki zdravljenja ob uporabi takih sestavkov
EP1532983A1 (en) * 2003-11-18 2005-05-25 ZLB Bioplasma AG Immunoglobulin preparations having increased stability
DE10355251A1 (de) * 2003-11-26 2005-06-23 Merck Patent Gmbh Pharmazeutische Zubereitung enthaltend einen Antikörper gegen den EGF-Rezeptor
DE10355904A1 (de) 2003-11-29 2005-06-30 Merck Patent Gmbh Feste Formen von anti-EGFR-Antikörpern
TW200530269A (en) 2003-12-12 2005-09-16 Chugai Pharmaceutical Co Ltd Anti-Mpl antibodies
WO2005056602A1 (ja) * 2003-12-12 2005-06-23 Chugai Seiyaku Kabushiki Kaisha アゴニスト活性を有する改変抗体のスクリーニング方法
EP1712565A4 (en) * 2003-12-12 2009-03-11 Chugai Pharmaceutical Co Ltd CELL-DOD INDUCING MEANS
JP4799405B2 (ja) * 2004-04-09 2011-10-26 中外製薬株式会社 細胞死誘導剤
KR100624013B1 (ko) * 2004-06-25 2006-09-19 주식회사 녹십자홀딩스 동결건조된 알부민 비함유 재조합 사람 혈액응고 제 8인자 제제
JP2007277094A (ja) * 2004-06-29 2007-10-25 Chemo Sero Therapeut Res Inst 改変ダニ主要アレルゲン含有医薬組成物
KR20180091967A (ko) 2004-07-22 2018-08-16 제넨테크, 인크. Ｈｅｒ２ 항체 조성물
TW200621282A (en) 2004-08-13 2006-07-01 Wyeth Corp Stabilizing formulations
CN101018560A (zh) * 2004-09-15 2007-08-15 大塚制药株式会社 经粘膜用组合物及提高经粘膜吸收的方法
JO3000B1 (ar) 2004-10-20 2016-09-05 Genentech Inc مركبات أجسام مضادة .
UA94899C2 (ru) * 2005-01-21 2011-06-25 Дженентек, Инк. Фиксированное дозирование антител к her
CN1313161C (zh) * 2005-01-27 2007-05-02 北京大学临床肿瘤学院 结直肠癌放射免疫导向手术药物及其制备方法
EP1850874B1 (en) * 2005-02-23 2013-10-16 Genentech, Inc. Extending time to disease progression or survival in ovarian cancer patients using pertuzumab
TW200722518A (en) 2005-03-31 2007-06-16 Chugai Pharmaceutical Co Ltd Sc(fv)2 structural isomers
WO2006112838A1 (en) * 2005-04-18 2006-10-26 Xtl Biopharmaceuticals Ltd. Stabilized anti-hepatitis b (hbv) antibody formulations
US8945543B2 (en) 2005-06-10 2015-02-03 Chugai Seiyaku Kabushiki Kaisha Stabilizer for protein preparation comprising meglumine and use thereof
JP5085322B2 (ja) 2005-06-10 2012-11-28 中外製薬株式会社 ｓｃ（Ｆｖ）２を含有する医薬組成物
ES2776657T3 (es) 2005-06-14 2020-07-31 Amgen Inc Formulaciones de proteínas autotamponantes
AU2007212147A1 (en) * 2006-02-03 2007-08-16 Medimmune, Llc Protein formulations
ES2391657T3 (es) * 2006-02-07 2012-11-28 Shire Human Genetic Therapies, Inc. Composiciones estabilizadas de proteínas que tienen un resto tiol libre
AU2013224728B2 (en) * 2006-02-07 2016-10-20 Takeda Pharmaceutical Company Limited Stabilized Compositions of Proteins Having a Free Thiol Moiety
CN101495136A (zh) * 2006-02-15 2009-07-29 英克隆系统公司 抗体配制品
US7846724B2 (en) 2006-04-11 2010-12-07 Hoffmann-La Roche Inc. Method for selecting CHO cell for production of glycosylated antibodies
BRPI0714209A2 (pt) * 2006-07-13 2014-06-24 Chugai Pharmaceutical Co Ltd Induzidor de morte celular
TW200826974A (en) * 2006-09-07 2008-07-01 Kirin Pharma Kk Stable lyophilized pharmaceutical preparation comprising antibody
EP2132573B1 (en) 2007-03-02 2014-04-23 Genentech, Inc. Predicting response to a her dimerisation inhbitor based on low her3 expression
WO2009002521A2 (en) * 2007-06-25 2008-12-31 Amgen Inc. Compositions of specific binding agents to hepatocyte growth factor
JOP20080381B1 (ar) 2007-08-23 2023-03-28 Amgen Inc بروتينات مرتبطة بمولدات مضادات تتفاعل مع بروبروتين كونفيرتاز سيتيليزين ككسين من النوع 9 (pcsk9)
US9308257B2 (en) * 2007-11-28 2016-04-12 Medimmune, Llc Protein formulation
US8883146B2 (en) 2007-11-30 2014-11-11 Abbvie Inc. Protein formulations and methods of making same
KR20090056543A (ko) * 2007-11-30 2009-06-03 주식회사 녹십자 Ｂ형 간염 바이러스(ｈｂｖ) 중화 인간 항체를 포함하는약학적 제제
TWI472339B (zh) 2008-01-30 2015-02-11 Genentech Inc 包含結合至ｈｅｒ２結構域ii之抗體及其酸性變異體的組合物
BRPI0812682A2 (pt) 2008-06-16 2010-06-22 Genentech Inc tratamento de cáncer de mama metastático
JO3672B1 (ar) 2008-12-15 2020-08-27 Regeneron Pharma أجسام مضادة بشرية عالية التفاعل الكيماوي بالنسبة لإنزيم سبتيليسين كنفرتيز بروبروتين / كيكسين نوع 9 (pcsk9).
US20130064834A1 (en) 2008-12-15 2013-03-14 Regeneron Pharmaceuticals, Inc. Methods for treating hypercholesterolemia using antibodies to pcsk9
AR075715A1 (es) * 2009-03-05 2011-04-20 Novartis Ag Formulacion de anticuerpo liofilizado
SG174258A1 (en) 2009-03-06 2011-10-28 Genentech Inc Antibody formulation
MX379016B (es) 2009-07-28 2025-03-10 Takeda Pharmaceuticals Co Composiciones y metodos para tratar enfermedad de gaucher.
US9345661B2 (en) 2009-07-31 2016-05-24 Genentech, Inc. Subcutaneous anti-HER2 antibody formulations and uses thereof
US8852954B2 (en) 2009-08-21 2014-10-07 Nec Solution Innovators, Ltd. Nucleic acid molecule having binding affinity to rodent-derived IgG antibody, binder, detection reagent, and detection kit
AR078161A1 (es) 2009-09-11 2011-10-19 Hoffmann La Roche Formulaciones farmaceuticas muy concentradas de un anticuerpo anti cd20. uso de la formulacion. metodo de tratamiento.
MX2012004682A (es) 2009-10-26 2012-09-07 Hoffmann La Roche Metodo para la produccion de una inmunoglobulina glicosilada.
DK2531218T3 (en) 2010-02-04 2019-04-01 Csl Behring Ag immunoglobulin
EP2361636A1 (en) 2010-02-26 2011-08-31 CSL Behring AG Immunoglobulin preparation and storage system for an immunoglobulin preparation
PL2542257T3 (pl) 2010-03-01 2018-01-31 Bayer Healthcare Llc Zoptymalizowane przeciwciała monoklonalne przeciwko inhibitorowi szlaku czynnika tkankowego (TFPI)
SG186421A1 (en) * 2010-07-02 2013-01-30 Medimmune Llc Antibody formulations
WO2012028683A1 (en) 2010-09-02 2012-03-08 Novartis Ag Antibody gel system for sustained drug delivery
CA2814054A1 (en) 2010-10-12 2012-04-19 Merz Pharma Gmbh & Co. Kgaa Formulation suitable for stabilizing proteins, which is free of mammalian excipients
TWI618543B (zh) 2010-11-05 2018-03-21 諾華公司 Ｉｌ-１７抗體用於製備治療強直性脊椎炎之藥物之用途
AU2011325974B2 (en) 2010-11-11 2016-10-27 Abbvie Biotechnology Ltd. Improved high concentration anti-TNFalpha antibody liquid formulations
PL2668212T3 (pl) 2011-01-28 2018-08-31 Sanofi Biotechnology Ludzkie przeciwciała przeciwko pcsk9 do zastosowania w sposobach leczenia konkretnych grup osobników
WO2012111762A1 (ja) 2011-02-17 2012-08-23 協和発酵キリン株式会社 抗ｃｄ４０抗体の高濃度製剤
MX341076B (es) * 2011-03-31 2016-08-04 Merck Sharp & Dohme Formulaciones estables de anticuerpos para el receptor humano pd-1 de meurte programada y tratamientos relacionados.
AU2012250924B2 (en) * 2011-05-02 2017-05-25 Immunomedics, Inc. Ultrafiltration concentration of allotype selected antibodies for small-volume administration
UA116189C2 (uk) * 2011-05-02 2018-02-26 Мілленніум Фармасьютікалз, Інк. КОМПОЗИЦІЯ АНТИ-α4β7 АНТИТІЛА
JOP20200043A1 (ar) 2011-05-10 2017-06-16 Amgen Inc طرق معالجة أو منع الاضطرابات المختصة بالكوليسترول
AR087305A1 (es) * 2011-07-28 2014-03-12 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit
PL4252857T3 (pl) 2011-09-16 2025-03-03 Regeneron Pharmaceuticals, Inc. Sposoby redukowania poziomów lipoproteiny(a) poprzez podawanie inhibitora proproteinowej konwertazy subtylizyny keksyny-9 (pcsk9)
ES3023516T3 (en) 2011-10-14 2025-06-02 Hoffmann La Roche Uses for and article of manufacture including her2 dimerization inhibitor pertuzumab
US10485869B2 (en) 2011-10-18 2019-11-26 Coherus Biosciences, Inc. Etanercept formulations stabilized with meglumine
EA026410B1 (ru) 2011-10-18 2017-04-28 Кохерус Байосайенсис, Инк. Композиции этанерцепта, стабилизированные комбинациями сахаров и полиолов
MX391043B (es) 2011-10-25 2025-03-21 Prothena Biosciences Ltd Formulaciones de anticuerpo y metodos.
KR102063028B1 (ko) 2012-01-23 2020-01-07 리제너론 파아마슈티컬스, 인크. 항-ａｎｇ2 항체를 함유하는 안정화된 제형
JP6230160B2 (ja) 2012-03-02 2017-11-15 シャイア ヒューマン ジェネティック セラピーズ インコーポレイテッド Ｉｉｉ型ゴーシェ病を治療するための組成物および方法
EP3412310B1 (en) * 2012-03-07 2022-09-07 Cadila Healthcare Limited Pharmaceutical formulations of tnf-alpha antibodies
AR092325A1 (es) 2012-05-31 2015-04-15 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-dll4 y kit
BR112015000203A2 (pt) 2012-07-09 2017-06-27 Coherus Biosciences Inc formulações de etanercept que exibem redução marcada em partículas sub-visíveis
US8883979B2 (en) 2012-08-31 2014-11-11 Bayer Healthcare Llc Anti-prolactin receptor antibody formulations
US8613919B1 (en) 2012-08-31 2013-12-24 Bayer Healthcare, Llc High concentration antibody and protein formulations
US9592297B2 (en) 2012-08-31 2017-03-14 Bayer Healthcare Llc Antibody and protein formulations
PE20150964A1 (es) 2012-09-07 2015-07-25 Coherus Biosciences Inc Formulaciones acuosas estables de adalimumab
WO2014043103A1 (en) 2012-09-11 2014-03-20 Coherus Biosciences, Inc. Correctly folded etanercept in high purity and excellent yield
CN102961745B (zh) * 2012-09-27 2015-02-18 苏州康聚生物科技有限公司 抗体组合物制剂及其应用
MY173295A (en) 2013-04-16 2020-01-14 Genentech Inc Pertuzumab variants and evaluation thereof
US10111953B2 (en) 2013-05-30 2018-10-30 Regeneron Pharmaceuticals, Inc. Methods for reducing remnant cholesterol and other lipoprotein fractions by administering an inhibitor of proprotein convertase subtilisin kexin-9 (PCSK9)
WO2014197752A1 (en) 2013-06-07 2014-12-11 Regeneron Pharmaceuticals, Inc. Methods fo inhibting atherosclerosis by administering an inhibitor of pcsk9
TWI670077B (zh) 2013-11-12 2019-09-01 賽諾菲生物技術公司 使用ｐｃｓｋ９抑制劑之給藥療程
RU2725093C2 (ru) 2014-04-25 2020-06-29 Дженентек, Инк. Способы лечения раннего рака молочной железы трастузумабом-mcc-dm1 и пертузумабом
IS3008B (is) * 2014-05-14 2018-12-15 Calor ehf Stöðgandi lausnir fyrir prótín og peptíð
RU2735521C2 (ru) 2014-07-16 2020-11-03 Санофи Байотекнолоджи Способы лечения пациентов с гетерозиготной семейной гиперхолестеринемией (hefh)
US9821059B2 (en) * 2014-10-17 2017-11-21 Alteogen Inc. Composition for stabilizing protein and pharmaceutical formulation comprising the same
EP3763384B1 (en) 2014-12-03 2024-08-28 CSL Behring AG Pharmaceutical product with increased stability comprising immunoglobulins
RU2672875C1 (ru) * 2014-12-17 2018-11-20 Пфайзер Инк. Композиции PI3K/MTOR-ингибитора для внутривенного введения
AR103173A1 (es) 2014-12-22 2017-04-19 Novarits Ag Productos farmacéuticos y composiciones líquidas estables de anticuerpos il-17
RU2749512C2 (ru) 2015-04-14 2021-06-11 Чугаи Сейяку Кабусики Кайся Фармацевтическая композиция для профилактики и/или лечения атопического дерматита, включающая антагонист ил-31 в качестве активного ингредиента
KR102514173B1 (ko) 2015-04-14 2023-03-27 추가이 세이야쿠 가부시키가이샤 Il-31 안타고니스트를 유효 성분으로서 함유하는 아토피성 피부염의 예방용 및/또는 치료용 의약 조성물
EP3287140B1 (en) 2015-04-21 2021-06-02 Staidson (Beijing) Biopharmaceuticals Co., Ltd. Nerve growth factor composition and powder injection
JP6822980B2 (ja) 2015-05-30 2021-01-27 ジェネンテック， インコーポレイテッド Ｈｅｒ２陽性転移性乳癌の治療方法
AU2016308111A1 (en) 2015-08-18 2018-03-01 Regeneron Pharmaceuticals, Inc. Anti-PCSK9 inhibitory antibodies for treating patients with hyperlipidemia undergoing lipoprotein apheresis
US11229702B1 (en) 2015-10-28 2022-01-25 Coherus Biosciences, Inc. High concentration formulations of adalimumab
WO2017087280A1 (en) 2015-11-16 2017-05-26 Genentech, Inc. Methods of treating her2-positive cancer
US10994011B2 (en) * 2015-12-18 2021-05-04 Astellas Pharma Inc. Pharmaceutical composition comprising anti-human TSLP receptor antibody
US11071782B2 (en) 2016-04-20 2021-07-27 Coherus Biosciences, Inc. Method of filling a container with no headspace
KR102037041B1 (ko) 2016-08-10 2019-10-29 (주)셀트리온 항-인플루엔자 바이러스 항체의 안정한 액체 약제학적 제제
WO2018068012A1 (en) 2016-10-07 2018-04-12 Regeneron Pharmaceuticals, Inc. Room temperature stable lyophilized protein
CA3040899A1 (en) 2016-10-21 2018-04-26 Amgen Inc. Pharmaceutical formulations and methods of making the same
ES2835376T3 (es) 2017-01-17 2021-06-22 Genentech Inc Formulaciones de anticuerpos frente a HER2 subcutáneas
CN114984206A (zh) 2017-03-02 2022-09-02 基因泰克公司 Her2阳性乳腺癌的辅助治疗
BR112020003862A2 (pt) * 2017-08-31 2020-09-08 Xellia Pharmaceuticals Aps formulações de daptomicina.
EP3923928B1 (en) 2019-02-15 2025-10-08 The Regents Of The University Of California Methods for converting colloidal systems to resuspendable/redispersible powders that preserve the original properties of the colloids
CN112206320B (zh) * 2019-07-12 2025-02-25 鲁南制药集团股份有限公司 一种cd47单克隆抗体冻干粉制剂及其制备工艺
CN112516301B (zh) * 2019-09-17 2025-03-18 鲁南制药集团股份有限公司 一种cd47单克隆抗体的液体制剂及其制备方法
WO2021100794A1 (ja) 2019-11-20 2021-05-27 中外製薬株式会社 抗体含有製剤
KR20230030621A (ko) 2020-06-29 2023-03-06 제넨테크, 인크. 퍼투주맙 + 트라스투주맙 고정 용량 조합
AU2023375895A1 (en) 2022-11-07 2025-05-15 Upstream Bio, Inc. Pharmaceutical compositions comprising anti-human tslp receptor antibodies and methods of using the same

Family Cites Families (43)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4016043A (en) * 1975-09-04 1977-04-05 Akzona Incorporated Enzymatic immunological method for the determination of antigens and antibodies
US4165370A (en) * 1976-05-21 1979-08-21 Coval M L Injectable gamma globulin
JPS56113713A (en) * 1980-02-14 1981-09-07 Chemo Sero Therapeut Res Inst Preparation of immunoglobulin with high content of monomer
US4439421A (en) 1982-08-30 1984-03-27 Baxter Travenol Laboratories, Inc. Stabilized gamma globulin concentrate
JPS60146833A (ja) 1984-01-10 1985-08-02 Green Cross Corp:The モノクロ−ナル抗体製剤
US4650772A (en) 1984-08-09 1987-03-17 Abbott Laboratories Monoclonal antibody stabilization
US4597966A (en) 1985-01-09 1986-07-01 Ortho Diagnostic Systems, Inc. Histidine stabilized immunoglobulin and method of preparation
JPH0825902B2 (ja) 1985-02-21 1996-03-13 株式会社ミドリ十字 γ−グロブリンの加熱処理方法
JPS6388197A (ja) 1986-09-30 1988-04-19 Tosoh Corp モノクロナル抗体の安定化方法
ES2053704T3 (es) 1987-02-20 1994-08-01 Akzo Nv Un metodo de estabilizacion de una composicion acuosa consistente en uno o mas anticuerpos monoclonales.
WO1988007089A1 (en) 1987-03-18 1988-09-22 Medical Research Council Altered antibodies
ATE82136T1 (de) 1987-08-10 1992-11-15 Miles Inc Gereinigtes igm.
JPS6475433A (en) 1987-09-16 1989-03-22 Teijin Ltd Remedy for herpes simplex virus infection
EP0407401B1 (en) 1988-02-26 1993-04-21 Genentech, Inc. Human relaxin formulation
US5096885A (en) 1988-04-15 1992-03-17 Genentech, Inc. Human growth hormone formulation
JPH03504605A (ja) 1988-05-27 1991-10-09 セントカー・インコーポレーテツド 抗体産生物の凍結乾燥した配合物
WO1989011298A1 (en) 1988-05-27 1989-11-30 Centocor, Inc. Formulation for antibody reagents
DE3825429C2 (de) 1988-07-27 1994-02-10 Biotest Pharma Gmbh Verfahren zur Herstellung eines intravenös verabreichbaren polyklonalen Immunglobulin-Präparates mit hohem IgM-Gehalt
US5468468A (en) * 1989-02-09 1995-11-21 The United States Of America, As Represented By The Secretary Of The Department Of Health & Human Services Method for making a monoclonal antibody, monoclonal antibodies to α PD
DE3927111C3 (de) * 1989-08-17 1994-09-01 Biotest Pharma Gmbh Verfahren zur Herstellung nicht modifizierter intravenös verabreichbarer IgM- und/oderIgA-haltiger Immunglobulinpräparate
GB9015824D0 (en) 1990-07-18 1990-09-05 Erba Carlo Spa Stable pharmaceutical compositions containing a fibroblast growth factor
JPH0565233A (ja) 1991-03-08 1993-03-19 Mitsui Toatsu Chem Inc モノクローナル抗体含有凍結乾燥製剤
US5440021A (en) 1991-03-29 1995-08-08 Chuntharapai; Anan Antibodies to human IL-8 type B receptor
WO1993000807A1 (en) 1991-07-03 1993-01-21 Cryolife, Inc. Method for stabilization of biomaterials
JP2966592B2 (ja) 1991-07-20 1999-10-25 萩原 義秀 安定化されたヒトモノクローナル抗体製剤
GB9120304D0 (en) * 1991-09-24 1991-11-06 Erba Carlo Spa Stable pharmaceutical compositions containing a granulocyte macrophage colony stimulating factor
IL101007A (en) 1992-02-18 1997-08-14 Pharmos Ltd Dry stable compositions prepared by lyophilization
US5639641A (en) 1992-09-09 1997-06-17 Immunogen Inc. Resurfacing of rodent antibodies
WO1994007510A1 (en) * 1992-10-02 1994-04-14 Kabi Pharmacia Ab Composition comprising coagulation factor viii formulation, process for its preparation and use of a surfactant as stabilizer
HUT72546A (en) 1992-11-06 1996-05-28 Sandoz Ag Production of human monoclonal antibodies active against hepatitis b surface antigen
RU2151612C1 (ru) 1992-12-01 2000-06-27 Протеин Дизайн Лэбс, Инк. Гуманизированный иммуноглобулин, специфичный для белка l-селектина человека
DE4242863A1 (de) 1992-12-18 1994-06-23 Boehringer Mannheim Gmbh Stabile lyophilisierte pharmazeutische Zubereitungen von G-CSF
US5385887A (en) * 1993-09-10 1995-01-31 Genetics Institute, Inc. Formulations for delivery of osteogenic proteins
ATE249234T1 (de) * 1993-12-17 2003-09-15 Mochida Pharm Co Ltd Lösliches thrombomodulin enthaltende zubereitung
DE4344824C1 (de) * 1993-12-28 1995-08-31 Immuno Ag Hochkonzentriertes Immunglobulin-Präparat und Verfahren zu seiner Herstellung
FR2719479B1 (fr) * 1994-05-04 1996-07-26 Sanofi Elf Formulation stable lyophilisée comprenant une protéine: kit de dosage.
ATE236993T1 (de) 1994-11-30 2003-04-15 Ajinomoto Kk Antithrombose mittel und gegen den von willebrand-faktor gerichtete monoklonale antikörper
CA2210620C (en) 1995-01-18 2004-06-22 Boehringer Mannheim Gmbh Anti-cd 30 antibodies preventing proteolytic cleavage and release of membrane-bound cd 30 antigen
DE19508192A1 (de) * 1995-03-09 1996-09-12 Behringwerke Ag Stabile Transglutaminasepräparate und Verfahren zu ihrer Herstellung
CA2226575C (en) * 1995-07-27 2011-10-18 Genentech, Inc. Stabile isotonic lyophilized protein formulation
US6267958B1 (en) * 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
DE19539574A1 (de) * 1995-10-25 1997-04-30 Boehringer Mannheim Gmbh Zubereitungen und Verfahren zur Stabilisierung biologischer Materialien mittels Trocknungsverfahren ohne Einfrieren
EP0852951A1 (de) * 1996-11-19 1998-07-15 Roche Diagnostics GmbH Stabile lyophilisierte pharmazeutische Zubereitungen von mono- oder polyklonalen Antikörpern

Also Published As

Publication number Publication date
WO1998022136A2 (de) 1998-05-28
CA2272245C (en) 2013-09-10
TR199901696T2 (xx) 1999-09-21
TW520291B (en) 2003-02-11
CN1155408C (zh) 2004-06-30
KR20000053328A (ko) 2000-08-25
ID19029A (id) 1998-06-04
AU5484198A (en) 1998-06-10
JP2009046494A (ja) 2009-03-05
CA2272245A1 (en) 1998-05-28
DE59711959D1 (de) 2004-10-28
JP2001503781A (ja) 2001-03-21
WO1998022136A3 (de) 1998-08-20
AU735411B2 (en) 2001-07-05
ATE276762T1 (de) 2004-10-15
AR012540A1 (es) 2000-11-08
CN1244805A (zh) 2000-02-16
US20080286280A1 (en) 2008-11-20
EP0941121A2 (de) 1999-09-15
US20140248274A1 (en) 2014-09-04
EP0941121B1 (de) 2004-09-22
ES2227727T3 (es) 2005-04-01
AU7824201A (en) 2001-11-22
AR074958A2 (es) 2011-02-23
BR9713521A (cs) 2000-03-21
JP5153532B2 (ja) 2013-02-27
EP0852951A1 (de) 1998-07-15
DK0941121T3 (da) 2005-01-31
KR100514207B1 (ko) 2005-09-13
PT941121E (pt) 2005-01-31
US8758747B2 (en) 2014-06-24
JP4536829B2 (ja) 2010-09-01
AU735411C (en) 2004-08-05
AU772940B2 (en) 2004-05-13

Similar Documents

Publication Publication Date Title
ZA9710409B (en) Stable lyophilised pharmaceutical preparations comprising mono- or polyclonal antibodies
PL330111A1 (en) Concentyratyed antibody preparation
IL129164A0 (en) Antibody against human parathormone related peptides
GB9613858D0 (en) Hydrophobic preparations
IL139235A0 (en) Pharmaceutical preparations
GB9603256D0 (en) Antibodies
ZA987644B (en) Preparation of functionalised polyethers.
IL122910A0 (en) Stable isotonic lyophilized protein formulation
IL136335A0 (en) Monoclonal human natural antibodies
PL328001A1 (en) Injectable quinolonic preparations
AU2721897A (en) Anti-cryptosporidium parvum preparations
EP1055684A4 (en) TUMORANTIGENS IN THE FORM OF PEPTIDE DERIVATIVES
GB9516461D0 (en) Antigenic preparations
EE9800275A (et) Misolastiini sisaldavad prolongeeritud toimega farmatseutilised preparaadid
AU2539697A (en) Anti-idiotypic antibody vaccines
GB2331521B (en) Vaccine preparations
CZ20011896A3 (cs) Imunogenní prostředek a protilátka
GB9929923D0 (en) Antigen preparations
ZA9710584B (en) Peptides antibodies vaccines and uses thereof
PL329866A1 (en) Monoclonal antibody against human mp52
GB9606159D0 (en) Recombinant antibodies
EP0596725A3 (en) Drug resistance-conferring protein, antibodies reactive therewith and utilities thereof.
GB9420892D0 (en) Recombinant antibodies
GB9226163D0 (en) Antibody blocking peptides
GB9207360D0 (en) Antigen preparation