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1. WO2015138844 - METHODS FOR PRODUCTION OF STABLE CHIMERIC CYTOKINE PROTEIN FORMULATIONS IN BLOW FILL SEAL CONTAINERS

Publication Number WO/2015/138844
Publication Date 17.09.2015
International Application No. PCT/US2015/020357
International Filing Date 13.03.2015
IPC
A61K 9/00 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
A61J 1/06 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
1Containers specially adapted for medical or pharmaceutical purposes
05for collecting, storing or administering blood, plasma or medical fluids
06Ampoules or cartridges
A61K 47/10 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
08containing oxygen
10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols ; Poloxamers; PEG/POE alkyl ethers
A61K 47/26 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
A61M 15/00 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
15Inhalators
CPC
A61K 38/2006
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38Medicinal preparations containing peptides
16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
17from animals; from humans
19Cytokines; Lymphokines; Interferons
20Interleukins [IL]
2006IL-1
A61K 47/10
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
08containing oxygen, ; e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
A61K 9/0048
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
0012Galenical forms characterised by the site of application
0048Eye, e.g. artificial tears
A61K 9/08
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
08Solutions
Applicants
  • ELEVEN BIOTHERAPEUTICS, INC. [US]/[US]
Inventors
  • ZARBIS-PAPASTOITSIS, Gregory
  • LOWDEN, Patricia
  • SCHIRMER, Emily, Belcher
  • WONG, Waiken, K.
Agents
  • MYERS, P., Louis
Priority Data
61/952,70113.03.2014US
Publication Language English (en)
Filing Language English (EN)
Designated States
Title
(EN) METHODS FOR PRODUCTION OF STABLE CHIMERIC CYTOKINE PROTEIN FORMULATIONS IN BLOW FILL SEAL CONTAINERS
(FR) PROCÉDÉS POUR LA PRODUCTION DE FORMULATIONS DE PROTÉINES CYTOKINE CHIMÉRIQUES STABLES DANS DES RÉCIPIENTS DU TYPE À SOUFFLAGE/REMPLISSAGE/FERMETURE
Abstract
(EN) Provided herein are stable formulations comprising a chimeric cytokine protein (e.g., an IL-1β/IL-1Ra chimeric cytokine protein, e.g., P05) in a blow-fill-seal (BFS) container, and methods of producing chimeric cytokine protein formulations in BFS containers such that the formulations retain stability.
(FR) La présente invention concerne des formulations stables comprenant une protéine cytokine chimérique (par exemple, une protéine cytokine chimérique IL-1β/IL-1Ra , par exemple, P05) dans un récipient du type à soufflage-remplissage-fermeture (BFS), et des procédés de production de formulations de protéine cytokine chimérique dans des récipients BFS, de sorte que les formulations conservent leur stabilité.
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