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1. WO2020008022 - METHOD FOR THE PRODUCTION OF FREEZE-DRIED PELLETS COMPRISING AN ANTI-COAGULATION FACTOR XIa (FXIa) ANTIBODY

Publication Number WO/2020/008022
Publication Date 09.01.2020
International Application No. PCT/EP2019/068071
International Filing Date 05.07.2019
IPC
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9
Medicinal preparations characterised by special physical form
14
Particulate form, e.g. powders
19
lyophilised
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9
Medicinal preparations characterised by special physical form
14
Particulate form, e.g. powders
16
Agglomerates; Granulates; Microbeadlets
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9
Medicinal preparations characterised by special physical form
08
Solutions
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47
Medicinal preparations characterised by the non-active ingredients used, e.g. carriers, inert additives
06
Organic compounds
08
containing oxygen
10
Alcohols; Phenols; Salts thereof
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47
Medicinal preparations characterised by the non-active ingredients used, e.g. carriers, inert additives
06
Organic compounds
16
containing nitrogen
18
Amines; Quaternary ammonium compounds
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47
Medicinal preparations characterised by the non-active ingredients used, e.g. carriers, inert additives
06
Organic compounds
26
Carbohydrates
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39
Medicinal preparations containing antigens or antibodies
395
Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
P
SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
7
Drugs for disorders of the blood or the extracellular fluid
02
Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
F MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
26
DRYING
B
DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
5
Drying solid materials or objects by processes not involving the application of heat
04
by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
06
the process involving freezing
A61K 9/19 (2006.01)
A61K 9/16 (2006.01)
A61K 9/08 (2006.01)
A61K 47/10 (2017.01)
A61K 47/18 (2017.01)
A61K 47/26 (2006.01)
CPC
A61K 2039/505
A61K 39/3955
A61K 47/10
A61K 47/183
A61K 47/26
A61K 9/0019
Applicants
  • BAYER AKTIENGESELLSCHAFT [DE/DE]; Kaiser-Wilhelm-Allee 1 51373 Leverkusen, DE
Inventors
  • SCHNEID, Stefan, Christian; DE
  • HEKE, Stefan; DE
  • PLITZKO, Matthias; DE
Agents
  • BIP PATENTS; Alfred-Nobel-Str. 10 40789 Monheim am Rhein NRW, DE
Priority Data
PCT/EP2018/06825005.07.2018EP
Publication Language English (EN)
Filing Language English (EN)
Designated States
Title
(EN) METHOD FOR THE PRODUCTION OF FREEZE-DRIED PELLETS COMPRISING AN ANTI-COAGULATION FACTOR XIa (FXIa) ANTIBODY
(FR) PROCÉDÉ POUR LA PRODUCTION DE COMPRIMÉS LYOPHILISÉS COMPRENANT UN ANTICORPS DU FACTEUR XIA ANTI-COAGULATION (FXIA)
Abstract
(EN)
A method for the production of freeze-dried pellets comprising an anti-FXIa antibody comprises the steps of: a) freezing droplets of a solution comprising an anti-FXIa antibody to form pellets; b) freeze-drying the pellets; wherein in step a) the droplets are formed by means of droplet formation of the solution comprising an anti-FXIa antibody into a cooling tower which has a temperature-controllable inner wall surface and an interior temperature below the freezing temperature of the solution and wherein in step b) the pellets are freeze-dried in a rotating receptacle which is housed inside a vacuum chamber.
(FR)
L'invention concerne un procédé pour la production de comprimés lyophilisés comprenant un anticorps anti-FXIa, qui comprend les étapes suivantes: a) congeler des gouttelettes d'une solution comprenant un anticorps anti-FXIa pour former des comprimés; b) lyophiliser les comprimés ; dans l'étape a), les gouttelettes étant formées au moyen de formation de gouttelettes de la solution comprenant un anticorps anti-FXIa dans une tour de refroidissement qui a une surface de paroi interne à température contrôlable et une température intérieure inférieure à la température de congélation de la solution et, dans l'étape b), les comprimés étant lyophilisés dans un réceptacle rotatif qui est logé à l'intérieur d'une chambre à vide.
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