JP2017537928A5 - - Google Patents

Download PDF

Info

Publication number
JP2017537928A5
JP2017537928A5 JP2017529817A JP2017529817A JP2017537928A5 JP 2017537928 A5 JP2017537928 A5 JP 2017537928A5 JP 2017529817 A JP2017529817 A JP 2017529817A JP 2017529817 A JP2017529817 A JP 2017529817A JP 2017537928 A5 JP2017537928 A5 JP 2017537928A5
Authority
JP
Japan
Prior art keywords
syringe
nominal volume
range
nominal
volume
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.)
Granted
Application number
JP2017529817A
Other languages
English (en)
Japanese (ja)
Other versions
JP2017537928A (ja
JP6726666B2 (ja
Filing date
Publication date
Application filed filed Critical
Priority claimed from PCT/EP2015/078482 external-priority patent/WO2016087569A1/en
Publication of JP2017537928A publication Critical patent/JP2017537928A/ja
Publication of JP2017537928A5 publication Critical patent/JP2017537928A5/ja
Application granted granted Critical
Publication of JP6726666B2 publication Critical patent/JP6726666B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

JP2017529817A 2014-12-03 2015-12-03 免疫グロブリンを含む安定性が高められた医薬製品 Active JP6726666B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP14196069 2014-12-03
EP14196069.0 2014-12-03
PCT/EP2015/078482 WO2016087569A1 (en) 2014-12-03 2015-12-03 Pharmaceutical product with increased stability comprising immunoglobulins

Publications (3)

Publication Number Publication Date
JP2017537928A JP2017537928A (ja) 2017-12-21
JP2017537928A5 true JP2017537928A5 (en:Method) 2018-12-27
JP6726666B2 JP6726666B2 (ja) 2020-07-22

Family

ID=52002817

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2017529817A Active JP6726666B2 (ja) 2014-12-03 2015-12-03 免疫グロブリンを含む安定性が高められた医薬製品

Country Status (15)

Country Link
US (2) US12144861B2 (en:Method)
EP (3) EP4450517A3 (en:Method)
JP (1) JP6726666B2 (en:Method)
KR (1) KR102745501B1 (en:Method)
CN (2) CN106999588A (en:Method)
AU (1) AU2015357068B2 (en:Method)
BR (1) BR112017010442A2 (en:Method)
CA (1) CA2968915A1 (en:Method)
DK (2) DK3763384T3 (en:Method)
ES (2) ES2988823T3 (en:Method)
HU (2) HUE069126T2 (en:Method)
MX (1) MX388043B (en:Method)
PL (2) PL3763384T3 (en:Method)
RU (1) RU2748841C2 (en:Method)
WO (1) WO2016087569A1 (en:Method)

Families Citing this family (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TR201903403T4 (tr) 2010-02-04 2019-04-22 Csl Behring Ag İmmünoglobulin preparatı.
EP2361636A1 (en) * 2010-02-26 2011-08-31 CSL Behring AG Immunoglobulin preparation and storage system for an immunoglobulin preparation
US11813328B2 (en) 2014-10-23 2023-11-14 Amgen Inc. Methods for reducing the viscosity of liquid pharmaceutical formulations comprising therapeutic proteins
DK3763384T3 (da) 2014-12-03 2024-09-23 Csl Behring Ag Farmaceuitisk produkt med øget stabilitet, omfattende immunoglobuliner
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
TWI865430B (zh) * 2017-07-24 2024-12-11 美商再生元醫藥公司 穩定化之抗體組合物及其製法
EP3797117A1 (en) * 2018-05-23 2021-03-31 CSL Behring AG Treatment of cidp
US12472162B2 (en) * 2018-07-24 2025-11-18 Carefusion 213, Llc Ready-to-use, terminally sterile packaging for surgical antiseptic and method of use
PT3659594T (pt) * 2018-11-30 2020-12-28 Stegemann Klaus Uma solução estéril com uma seringa de aplicação que contém um agente ativo médico e processo para a sua disponibilização
AU2020323937B2 (en) 2019-07-29 2025-09-25 Regeneron Pharmaceuticals, Inc. Medical device packaging and related methods
US20220323670A1 (en) * 2021-04-08 2022-10-13 Genixus, Corp. Syringe prefilled with pharmaceutical fluid
WO2023102398A2 (en) * 2021-11-30 2023-06-08 Sab, Llc Ungulate-derived polyclonal immunoglobulin specific for influenza virus and uses thereof
USD1035436S1 (en) 2022-08-26 2024-07-16 Regeneron Pharmaceuticals, Inc. Packaging
USD1042107S1 (en) 2022-08-26 2024-09-17 Regeneron Pharmaceuticals, Inc. Packaging
USD1047700S1 (en) 2022-08-26 2024-10-22 Regeneron Pharmaceuticals, Inc. Packaging
WO2024200757A1 (en) 2023-03-29 2024-10-03 Csl Behring Ag Methods of identifying immunoglobulin associated with adverse reactions

Family Cites Families (71)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2364792A1 (de) 1973-01-15 1974-07-18 South African Inventions Verfahren zum reinigen von gammaglobulin
JPS5420124A (en) 1977-07-14 1979-02-15 Green Cross Corp:The Preparation of gamma-globulin intravenous injection
US4186192A (en) 1978-12-18 1980-01-29 Cutter Laboratories, Inc. Stabilized immune serum globulin
US4362661A (en) 1979-08-09 1982-12-07 Teijin Limited Immunoglobulin composition having a high monomer content, and process for production thereof
JPS5731623A (en) 1980-07-30 1982-02-20 Morishita Seiyaku Kk Production of gamma-globulin for intravenous injection
JPS56127321A (en) 1980-03-10 1981-10-06 Mochida Pharmaceut Co Ltd Preparation of gamma-globulin pharmaceutical
JPS56135418A (en) 1980-03-27 1981-10-22 Green Cross Corp:The Heat treatment of aqueous solution containing 8 factor of coagulation of blood derived from human
JPS57128635A (en) 1981-01-30 1982-08-10 Morishita Seiyaku Kk Pharmaceutical preparation of gamma-globulin for venoclysis
US4360451A (en) 1981-08-10 1982-11-23 Basf Wyandotte Corporation Amphoteric surfactant gels
US4396608A (en) 1981-08-24 1983-08-02 Cutter Laboratories Intravenously injectable immune serum globulin
US4499073A (en) 1981-08-24 1985-02-12 Cutter Laboratories, Inc. Intravenously injectable immune serum globulin
US4439421A (en) 1982-08-30 1984-03-27 Baxter Travenol Laboratories, Inc. Stabilized gamma globulin concentrate
JPS6042336A (ja) 1983-08-18 1985-03-06 Nippon Seiyaku Kk 免疫グロブリンの製造方法
JPS60120823A (ja) 1983-12-02 1985-06-28 Green Cross Corp:The IgG単量体
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
JPH0825903B2 (ja) 1985-05-16 1996-03-13 株式会社ミドリ十字 γ―グロブリン含有水溶液
GB8628104D0 (en) 1986-11-25 1986-12-31 Connaught Lab Pasteurization of immunoglobin solutions
DE3641115A1 (de) 1986-12-02 1988-06-16 Lentia Gmbh Verfahren zur herstellung eines intravenoes anwendbaren und in fluessiger form stabilen immunglobulins
EP0392717A1 (en) 1989-04-04 1990-10-17 Eli Lilly And Company Pharmaceutical formulations containing immunoglobulin conjugates
JPH0341033A (ja) 1989-07-07 1991-02-21 Kyowa Hakko Kogyo Co Ltd 安定なモチリン類含有製剤
US5177194A (en) 1990-02-01 1993-01-05 Baxter International, Inc. Process for purifying immune serum globulins
US5945098A (en) 1990-02-01 1999-08-31 Baxter International Inc. Stable intravenously-administrable immune globulin preparation
DE59009020D1 (de) 1990-03-22 1995-06-08 Biotest Pharma Gmbh Verfahren zur Herstellung eines intravenös verträglichen Immunglobulin-G-Präparates.
JPH04346934A (ja) 1991-05-24 1992-12-02 Green Cross Corp:The γ−グロブリンの液状製剤
DE4118912C1 (en:Method) 1991-06-08 1992-07-02 Biotest Pharma Gmbh, 6072 Dreieich, De
DE4126983A1 (de) 1991-08-15 1993-02-18 Boehringer Mannheim Gmbh Verfahren zur herstellung von humanprotein-enthaltenden, konservierten arzneimitteln fuer infusions- oder injektionszwecke
JP2942412B2 (ja) 1991-12-26 1999-08-30 鐘紡株式会社 化粧料
FR2706466B1 (fr) 1993-06-14 1995-08-25 Aetsrn Concentré d'immunoglobulines G à usage thérapeutique et procédé de production dudit concentré.
ES2129076T5 (es) 1993-12-27 2003-05-16 Zlb Bioplasma Ag Procedimiento para la preparacion de un concentrado de inmunoglobulina g anti-d y composicion farmaceutica que lo contiene.
JPH07238036A (ja) 1994-02-28 1995-09-12 Green Cross Corp:The 静注用グロブリン液状組成物のグロブリン二量体増加抑制方法
GB9418092D0 (en) 1994-09-08 1994-10-26 Red Cross Found Cent Lab Blood Organic compounds
JP3765108B2 (ja) 1994-09-30 2006-04-12 三菱ウェルファーマ株式会社 静脈注射用グロブリン製剤
AU705010B2 (en) 1994-11-16 1999-05-13 Arizona Board Of Regents On Behalf Of The University Of Arizona, The Human antibodies to t-cell receptor peptides and methods for their preparation
GB9610992D0 (en) 1996-05-24 1996-07-31 Glaxo Group Ltd Concentrated antibody preparation
TW491855B (en) 1996-08-07 2002-06-21 Csl Ltd Purification of immunoglobulins
EP0852951A1 (de) 1996-11-19 1998-07-15 Roche Diagnostics GmbH Stabile lyophilisierte pharmazeutische Zubereitungen von mono- oder polyklonalen Antikörpern
TR199901968T2 (xx) 1996-12-24 1999-12-21 Biogen, Inc. Sabit s�v� interferon form�lleri.
US6171586B1 (en) 1997-06-13 2001-01-09 Genentech, Inc. Antibody formulation
US5886154A (en) 1997-06-20 1999-03-23 Lebing; Wytold R. Chromatographic method for high yield purification and viral inactivation of antibodies
ES2182202T5 (es) 1997-10-23 2007-12-01 Mitsubishi Pharma Corporation Preparacion de inmunoglobulinas para inyeccion intravenosa apta para ser almacenada a temperatura ambiente.
US6162904A (en) 1997-12-24 2000-12-19 Alpha Therapeutic Corporation Manufacturing method for intraveneously administrable immune globulin and resultant product
AU753468B2 (en) 1998-06-09 2002-10-17 Csl Behring Ag Process for producing immunoglobulins for intravenous administration and other immunoglobulin products
SE0001128D0 (sv) 2000-03-30 2000-03-30 Amersham Pharm Biotech Ab A method of producing IgG
US6887462B2 (en) 2001-04-09 2005-05-03 Chiron Corporation HSA-free formulations of interferon-beta
GB0113179D0 (en) 2001-05-31 2001-07-25 Novartis Ag Organic compounds
AT410637B (de) * 2001-06-01 2003-06-25 Igeneon Krebs Immuntherapie Verwendung von polyklonalen immunglobulinen
WO2003039632A2 (en) 2001-11-02 2003-05-15 Meridian Medical Technologies, Inc. A medicament container, a medicament dispensing kit for administering medication and a method for packaging the same
EP1539212A4 (en) * 2002-07-12 2007-05-02 Medarex Inc METHOD AND COMPOSITIONS FOR PREVENTING OXIDATIVE DEGRADATION OF PROTEINS
WO2004084816A2 (en) 2003-03-21 2004-10-07 Progenics Pharmaceuticals, Inc. IMPROVED CD4-IgG2 FORMULATIONS
US20050075611A1 (en) * 2003-10-01 2005-04-07 Hetzler Kevin G. Low extractable, thermoplastic syringe and tip cap
EP1532983A1 (en) 2003-11-18 2005-05-25 ZLB Bioplasma AG Immunoglobulin preparations having increased stability
US20060051347A1 (en) 2004-09-09 2006-03-09 Winter Charles M Process for concentration of antibodies and therapeutic products thereof
US20060076536A1 (en) * 2004-09-29 2006-04-13 Barshied Scott R Oxygen scavenging pharmaceutical package and methods for making same
EP1767347A1 (de) * 2005-09-27 2007-03-28 Alcan Technology & Management Ltd. Deckfolie für Blisterverpackungen
US8852167B2 (en) 2005-12-01 2014-10-07 Bayer Medical Care Inc. Medical connector
US20100129379A1 (en) 2006-09-25 2010-05-27 John Carpenter Stabilized antibody formulations and uses thereof
GB0619060D0 (en) 2006-09-27 2006-11-08 Glaxosmithkline Biolog Sa Novel process
MX2010008696A (es) * 2008-02-07 2010-08-30 Amgen Inc Composiciones de proteina estabilizadas.
GB2471726B (en) * 2009-07-10 2013-09-11 Oval Medical Technologies Ltd A pre-filled syringe including an oxygen absorber
DK2477603T3 (en) 2009-09-17 2016-06-13 Baxalta Inc STABLE CO-DEVELOPMENT OF hyaluronidase and Immunoglobulin, AND METHODS OF USE THEREOF
EA031209B9 (ru) 2010-01-15 2021-11-19 Кирин-Эмджен, Инк. Фармацевтический состав антитела для лечения воспалительного заболевания и способы его применения
TR201903403T4 (tr) 2010-02-04 2019-04-22 Csl Behring Ag İmmünoglobulin preparatı.
EP2361636A1 (en) 2010-02-26 2011-08-31 CSL Behring AG Immunoglobulin preparation and storage system for an immunoglobulin preparation
WO2012022734A2 (en) 2010-08-16 2012-02-23 Medimmune Limited Anti-icam-1 antibodies and methods of use
KR102014512B1 (ko) 2011-05-02 2019-08-26 밀레니엄 파머슈티컬스 인코퍼레이티드 항-α4β7 항체에 대한 제형
FR2995213A1 (fr) 2012-09-12 2014-03-14 Lfb Biotechnologies Seringue contenant une composition, notamment pharmaceutique, comprenant des immunoglobulines, son procede de fabrication et son utilisation
EP3424547B1 (en) * 2013-03-14 2026-02-11 Fresenius Kabi Austria GmbH Packaging system for oxygen-sensitive drugs
CA2902343C (en) * 2013-03-14 2022-08-02 Becton Dickinson France S.A.S. Injectable morphine formulations
CN107106409A (zh) * 2014-10-02 2017-08-29 泰尔茂株式会社 用于容纳蛋白质溶液制剂的医疗用容器
DK3763384T3 (da) 2014-12-03 2024-09-23 Csl Behring Ag Farmaceuitisk produkt med øget stabilitet, omfattende immunoglobuliner

Similar Documents

Publication Publication Date Title
JP2017537928A5 (en:Method)
JP2016065085A5 (en:Method)
JP2018012698A5 (en:Method)
JP2015053053A5 (en:Method)
EA201790630A1 (ru) Способы получения рибозидов
WO2015153889A3 (en) Materials and methods for the treatment of latent viral infection
MA41265A (fr) Compositions pour administration de médicaments iléo-jéjunal.
WO2016011222A3 (en) Circular polynucleotides
JP2016027901A5 (en:Method)
EA201691991A1 (ru) Мультиспецифические антитела
JP2016502162A5 (en:Method)
JP2014237817A5 (en:Method)
IL247111A0 (en) Preventive or therapeutic agent for kidney disease
LT3390390T (lt) Bipirazolilo dariniai, tinkami naudoti autoimuninių ligų gydymui
JP2018533683A5 (en:Method)
FR3041503B1 (fr) Projectiles oxodegradables contenant des pheromones
JP2015186128A5 (en:Method)
JP2016540026A5 (en:Method)
JP2015173751A5 (en:Method)
JP2016540019A5 (en:Method)
WO2015138532A3 (en) Methods for the treatment of kidney fibrosis
JP2016038993A5 (en:Method)
JP2015016294A5 (en:Method)
UY4430S (es) “motocicleta”.
IL257940A (en) Vaccine compositions comprising c-c motif chemokine 22 (ccl22) or fragments thereof