CA2859287A1 - Reconstitution method for high concentration dry protein formulations - Google Patents

Reconstitution method for high concentration dry protein formulations Download PDF

Info

Publication number
CA2859287A1
CA2859287A1 CA2859287A CA2859287A CA2859287A1 CA 2859287 A1 CA2859287 A1 CA 2859287A1 CA 2859287 A CA2859287 A CA 2859287A CA 2859287 A CA2859287 A CA 2859287A CA 2859287 A1 CA2859287 A1 CA 2859287A1
Authority
CA
Canada
Prior art keywords
reconstitution
dry
protein
vessel
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.)
Abandoned
Application number
CA2859287A
Other languages
English (en)
French (fr)
Inventor
Jan Vos
Andrew John MACLEOD
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
XSTALBIO Ltd
Original Assignee
XSTALBIO Ltd
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
Application filed by XSTALBIO Ltd filed Critical XSTALBIO Ltd
Publication of CA2859287A1 publication Critical patent/CA2859287A1/en
Abandoned legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/716Glucans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/38Albumins
    • A61K38/385Serum albumin
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Zoology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Medicinal Preparation (AREA)
  • Degasification And Air Bubble Elimination (AREA)
  • Mixers With Rotating Receptacles And Mixers With Vibration Mechanisms (AREA)
CA2859287A 2011-12-23 2012-12-24 Reconstitution method for high concentration dry protein formulations Abandoned CA2859287A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GB1122430.0 2011-12-23
GBGB1122430.0A GB201122430D0 (en) 2011-12-23 2011-12-23 Reconstitution method for high concentration dry protein formulation
PCT/GB2012/053266 WO2013093525A1 (en) 2011-12-23 2012-12-24 Reconstitution method for high concentration dry protein formulations

Publications (1)

Publication Number Publication Date
CA2859287A1 true CA2859287A1 (en) 2013-06-27

Family

ID=45695059

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2859287A Abandoned CA2859287A1 (en) 2011-12-23 2012-12-24 Reconstitution method for high concentration dry protein formulations

Country Status (8)

Country Link
US (1) US20140308293A1 (enExample)
EP (1) EP2793852A1 (enExample)
JP (1) JP2015511129A (enExample)
BR (1) BR112014015605A2 (enExample)
CA (1) CA2859287A1 (enExample)
GB (1) GB201122430D0 (enExample)
IN (1) IN2014MN01381A (enExample)
WO (1) WO2013093525A1 (enExample)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB201313368D0 (en) 2013-07-26 2013-09-11 Xstalbio Ltd Novel Reconstitution devices
US20170274012A1 (en) * 2014-09-03 2017-09-28 Entegrion, Inc. Acceleration of Reconstitution of Plasma Powder by Mixing with Small Beads
US10143625B2 (en) * 2015-03-17 2018-12-04 Recon Therapeutics, Inc. Pharmaceutical reconstitution
SG11201901081XA (en) * 2016-08-17 2019-03-28 Boehringer Ingelheim Int Process for the preparation of highly concentrated liquid formulations containing biomolecules

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5178884A (en) * 1988-05-18 1993-01-12 Cryopharm Corporation Lyophilized and reconstituted red blood cell compositions
DE4416166C2 (de) * 1994-05-06 1997-11-20 Immuno Ag Stabiles Präparat zur Behandlung von Blutgerinnungsstörungen
DE10211227A1 (de) * 2002-03-13 2003-10-02 Aventis Behring Gmbh Verfahren zur Rekonstitution von Iyophilisierten Proteinen
AU2007234612B2 (en) * 2006-12-14 2013-06-27 Johnson & Johnson Regenerative Therapeutics, Llc Protein stabilization formulations
EP1958618A1 (de) * 2007-02-15 2008-08-20 Octapharma AG Verfahren zur Gefriertrocknung mit optimierter Rekonstitution von Biopolymeren
EP2458990B1 (en) 2009-07-28 2016-03-30 Merck Sharp & Dohme Corp. Methods for producing high concentration lyophilized pharmaceutical formulations

Also Published As

Publication number Publication date
IN2014MN01381A (enExample) 2015-04-17
US20140308293A1 (en) 2014-10-16
WO2013093525A1 (en) 2013-06-27
EP2793852A1 (en) 2014-10-29
JP2015511129A (ja) 2015-04-16
GB201122430D0 (en) 2012-02-08
BR112014015605A2 (pt) 2017-07-04

Similar Documents

Publication Publication Date Title
DK2793863T3 (en) PROCEDURE FOR THE PREPARATION OF AMORPH PRECIPTATED PROTEIN PARTICLES
AU2016200495A1 (en) Concentrated protein formulations and uses thereof
MX2014010776A (es) Formulaciones farmaceuticas de anticuerpos tnf-alfa.
EP3688033A1 (en) Novel formulations which stabilize low dose antibody compositions
US20180098936A1 (en) Methods and compositions for injecting high concentration and/or high viscosity active agent solutions
US8372798B2 (en) High-concentration protein formulations and method of manufacture
EA036042B1 (ru) Стабилизированные составы, содержащие антитела анти-pcsk9
US20140308293A1 (en) Reconstitution method for high concentration dry protein formulations
KR20220008277A (ko) 가스 충전된 미세소포
CA3162569A1 (en) Stable antibody formulation
US20110155620A1 (en) Rapid reconstitution for lyophilized-pharmaceutical suspensions
HK1250147A1 (zh) 一种冻干药物制剂及其用途
Shire et al. High-concentration antibody formulations
JP7813703B2 (ja) 抗cd20×抗cd3二重特異性抗体を含有する安定化製剤
WO2022212885A1 (en) Stabilized formulations containing anti-muc16 x anti-cd3 bispecific antibodies
AU2021305093A1 (en) Stabilized formulations containing anti-CTLA-4 antibodies
Zhang Process optimization of albumin-stabilized mitotane nanoparticle preparation by dual centrifugation and first lyophilization study
CA3231500A1 (en) Injectable high concentration pharmaceutical formulations and methods of manufacturing and use thereof
EA051038B1 (ru) Стабилизированные составы, содержащие биспецифические антитела к muc16 и к cd3
CN117320700A (zh) 含有抗muc16 x抗cd3双特异性抗体的稳定制剂

Legal Events

Date Code Title Description
FZDE Discontinued

Effective date: 20161228