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1. WO2021240458 - AN IMPROVED PROCESS OF STORING AND PREPARING THE PROTEIN

Publication Number WO/2021/240458
Publication Date 02.12.2021
International Application No. PCT/IB2021/054693
International Filing Date 28.05.2021
IPC
A61K 9/19 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
14Particulate form, e.g. powders
19lyophilised
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
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
A61K 47/12 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
12Carboxylic acids; Salts or anhydrides thereof
A61K 9/08 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
08Solutions
C07K 16/00 2006.1
CCHEMISTRY; METALLURGY
07ORGANIC CHEMISTRY
KPEPTIDES
16Immunoglobulins, e.g. monoclonal or polyclonal antibodies
CPC
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
C07K 16/00
CCHEMISTRY; METALLURGY
07ORGANIC CHEMISTRY
KPEPTIDES
16Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
C07K 16/4291
CCHEMISTRY; METALLURGY
07ORGANIC CHEMISTRY
KPEPTIDES
16Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
42against immunoglobulins
4283against an allotypic or isotypic determinant on Ig
4291against IgE
Applicants
  • KASHIV BIOSCIENCES, LLC [US]/[US]
Inventors
  • NARAYAN, Om
  • GUPTA, Tarun Kumar
  • THAKKAR, Mayankkumar
  • GALANI, Kishor
Priority Data
20202102237428.05.2020IN
Publication Language English (en)
Filing Language English (EN)
Designated States
Title
(EN) AN IMPROVED PROCESS OF STORING AND PREPARING THE PROTEIN
(FR) PROCÉDÉ AMÉLIORÉ DE STOCKAGE ET DE PRÉPARATION DE LA PROTÉINE
Abstract
(EN) The present invention provides a method for reducing the protein aggregation by adjusting the pH below 6.0 of liquid formulation comprising the antibody or fusion protein. The present invention also provides methods for storing the pre-formulation for longer period without using any sugar or additives which can be utilized for preparation of liquid or lyophilized formulation.
(FR) La présente invention concerne un procédé de réduction de l'agrégation de protéines par ajustement du pH au-dessous de 6,0 d'une formulation liquide comprenant l'anticorps ou la protéine de fusion. La présente invention concerne également des procédés de stockage de la pré-formulation pendant une période plus longue sans utiliser de sucre ou d'additifs qui peuvent être utilisés pour la préparation d'une formulation liquide ou lyophilisée.
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