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1. WO2017031288 - STABLE ANTI-IFNAR1 FORMULATION

Publication Number WO/2017/031288
Publication Date 23.02.2017
International Application No. PCT/US2016/047506
International Filing Date 18.08.2016
IPC
A61K 39/00 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39Medicinal preparations containing antigens or antibodies
A61K 39/395 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39Medicinal preparations containing antigens or antibodies
395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
C07K 16/00 2006.1
CCHEMISTRY; METALLURGY
07ORGANIC CHEMISTRY
KPEPTIDES
16Immunoglobulins, e.g. monoclonal or polyclonal antibodies
C07K 16/18 2006.1
CCHEMISTRY; METALLURGY
07ORGANIC CHEMISTRY
KPEPTIDES
16Immunoglobulins, e.g. monoclonal or polyclonal antibodies
18against material from animals or humans
C07K 16/28 2006.1
CCHEMISTRY; METALLURGY
07ORGANIC CHEMISTRY
KPEPTIDES
16Immunoglobulins, e.g. monoclonal or polyclonal antibodies
18against material from animals or humans
28against receptors, cell surface antigens or cell surface determinants
C12P 21/00 2006.1
CCHEMISTRY; METALLURGY
12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
PFERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERS FROM A RACEMIC MIXTURE
21Preparation of peptides or proteins
CPC
A61K 39/395
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39Medicinal preparations containing antigens or antibodies
395Antibodies
A61K 39/39591
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39Medicinal preparations containing antigens or antibodies
395Antibodies
39591Stabilisation, fragmentation
A61K 9/0019
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
0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
A61P 1/04
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
1Drugs for disorders of the alimentary tract or the digestive system
04for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
A61P 1/14
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
1Drugs for disorders of the alimentary tract or the digestive system
14Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
A61P 13/12
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
13Drugs for disorders of the urinary system
12of the kidneys
Applicants
  • ASTRAZENECA AB [SE]/[SE]
Inventors
  • DEPAZ, Roberto
  • DEJESUS, Natalie
  • BEE, Jared
Agents
  • OYLOE, Jacob, S.
Priority Data
62/207,16419.08.2015US
Publication Language English (en)
Filing Language English (EN)
Designated States
Title
(EN) STABLE ANTI-IFNAR1 FORMULATION
(FR) FORMULATION ANTI-IFNAR1 STABLE
Abstract
(EN) The present invention relates to a stable, low viscosity antibody formulation, wherein the formulation comprises a high concentration of anti- INFARl antibody. In some embodiments, the invention relates in general to a stable antibody formulation comprising about 100 mg/mL to about 200 mg/mL of an antibody or fragment thereof that specifically binds human interferon alpha 1 (INFARl); about 20 mM to about 80 mM of a lysine or a salt thereof; about 0.02% to about 0.06% of a surfactant; an uncharged excipient; and a formulation buffer. In some embodiments, the invention is directed to a container, dosage form and/or kit. In some embodiments, the invention is directed to a method of making and using the stable antibody formulation.
(FR) La présente invention concerne une formulation d'anticorps, stable, à faible viscosité, ladite formulation comprenant une concentration élevée d'anticorps anti-INFARl. Dans certains modes de réalisation, l'invention concerne d'une manière générale une formulation stable d'anticorps comprenant entre environ 100 mg/mL et environ 200 mg/mL d'un anticorps ou d'un fragment de celui-ci qui se lie spécifiquement à l’interféron alpha 1 (INFARl), entre environ 20 mM et environ 80 mM d'une lysine ou d’un sel de celle-ci; entre environ 0,02 % et environ 0,06 % d'un tensioactif; un excipient non chargé; et un tampon de formulation. Dans certains modes de réalisation, l'invention concerne un contenant, une forme galénique et/ou un kit. Dans certains modes de réalisation, l'invention concerne un procédé de préparation et d'utilisation de la formulation stable d'anticorps.
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