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MX2021008985A - Procedimiento de fabricacion continuo para la fabricacion de productos biologicos mediante integracion de procedimientos de principio activo y producto terminado. - Google Patents

Procedimiento de fabricacion continuo para la fabricacion de productos biologicos mediante integracion de procedimientos de principio activo y producto terminado.

Info

Publication number
MX2021008985A
MX2021008985A MX2021008985A MX2021008985A MX2021008985A MX 2021008985 A MX2021008985 A MX 2021008985A MX 2021008985 A MX2021008985 A MX 2021008985A MX 2021008985 A MX2021008985 A MX 2021008985A MX 2021008985 A MX2021008985 A MX 2021008985A
Authority
MX
Mexico
Prior art keywords
integration
manufacture
finished product
active principle
manufacturing procedure
Prior art date
Application number
MX2021008985A
Other languages
English (en)
Inventor
Sai Chakradhar Padala
Malhar R Ambhaikar
Vincent Chai
Philip Clark
Subramanian GUHAN
Nitin Rathore
Zane Saremi
Ashish Sharma
Kenneth Shoemaker
Balakumar Thangaraj
John E Thorup
Benjamin J Tillotson
Hann-Chung Wong
Original Assignee
Amgen Inc
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 Amgen Inc filed Critical Amgen Inc
Publication of MX2021008985A publication Critical patent/MX2021008985A/es

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/14—Ultrafiltration; Microfiltration
    • B01D61/145—Ultrafiltration
    • B01D61/146—Ultrafiltration comprising multiple ultrafiltration steps
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D63/00—Apparatus in general for separation processes using semi-permeable membranes
    • B01D63/02—Hollow fibre modules
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/34—Extraction; Separation; Purification by filtration, ultrafiltration or reverse osmosis
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/36—Extraction; Separation; Purification by a combination of two or more processes of different types
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2809—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against the T-cell receptor (TcR)-CD3 complex
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2315/00—Details relating to the membrane module operation
    • B01D2315/16—Diafiltration
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2317/00—Membrane module arrangements within a plant or an apparatus
    • B01D2317/02—Elements in series
    • B01D2317/022—Reject series
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D71/00—Semi-permeable membranes for separation processes or apparatus characterised by the material; Manufacturing processes specially adapted therefor
    • B01D71/06—Organic material
    • B01D71/30—Polyalkenyl halides
    • B01D71/32—Polyalkenyl halides containing fluorine atoms
    • B01D71/34—Polyvinylidene fluoride
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Water Supply & Treatment (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Cell Biology (AREA)
  • Dermatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Inorganic Chemistry (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)

Abstract

Un procedimiento de fabricación de productos biológicos que conecta los procedimientos de principio activo y producto terminado en un procedimiento continuo, integrado.
MX2021008985A 2019-01-28 2020-01-27 Procedimiento de fabricacion continuo para la fabricacion de productos biologicos mediante integracion de procedimientos de principio activo y producto terminado. MX2021008985A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201962797445P 2019-01-28 2019-01-28
PCT/US2020/015137 WO2020159838A1 (en) 2019-01-28 2020-01-27 A continuous manufacturing process for biologics manufacturing by integration of drug substance and drug product processes

Publications (1)

Publication Number Publication Date
MX2021008985A true MX2021008985A (es) 2021-09-08

Family

ID=69740575

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2021008985A MX2021008985A (es) 2019-01-28 2020-01-27 Procedimiento de fabricacion continuo para la fabricacion de productos biologicos mediante integracion de procedimientos de principio activo y producto terminado.

Country Status (15)

Country Link
US (1) US20220119526A1 (es)
EP (1) EP3917494A1 (es)
JP (2) JP7617004B2 (es)
KR (1) KR20210120032A (es)
CN (2) CN118994410A (es)
AR (1) AR117896A1 (es)
AU (1) AU2020216108A1 (es)
BR (1) BR112021014634A2 (es)
CA (1) CA3127258A1 (es)
CL (2) CL2021001958A1 (es)
EA (1) EA202192108A1 (es)
IL (1) IL284782A (es)
MX (1) MX2021008985A (es)
SG (1) SG11202107714VA (es)
WO (1) WO2020159838A1 (es)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4058485A1 (en) * 2019-11-13 2022-09-21 Amgen Inc. Method for reduced aggregate formation in downstream processing of bispecific antigen-binding molecules
AR121061A1 (es) * 2020-01-15 2022-04-13 Hoffmann La Roche Métodos para disminuir impurezas de los procesos de fabricación de proteínas recombinantes
WO2021220251A1 (en) * 2020-05-01 2021-11-04 Kashiv Biosciences, Llc An improved process of purification of protein
US20240076709A1 (en) 2022-09-06 2024-03-07 Amgen Inc. Lean perfusion cell culture methods
AR130495A1 (es) 2022-09-16 2024-12-11 Amgen Inc Un método para recoger productos a partir de cultivos en perfusión
US20240307803A1 (en) 2023-03-13 2024-09-19 Amgen Inc. Virus filtration operations employing an oversized virus prefilter
WO2024191970A1 (en) 2023-03-14 2024-09-19 Amgen Inc. Anion exchange chromatography processes using a primary amine ligand
US20240426793A1 (en) 2023-06-20 2024-12-26 Amgen Inc. Methods for chromatography and chromatography medium reuse
WO2025029614A1 (en) 2023-07-28 2025-02-06 Amgen Inc. A method for equilibrating a chromatography medium

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US6319494B1 (en) 1990-12-14 2001-11-20 Cell Genesys, Inc. Chimeric chains for receptor-associated signal transduction pathways
IL104570A0 (en) 1992-03-18 1993-05-13 Yeda Res & Dev Chimeric genes and cells transformed therewith
AU761587B2 (en) 1998-04-21 2003-06-05 Amgen Research (Munich) Gmbh CD19xCD3 specific polypeptides and uses thereof
ES2358427T3 (es) 2003-10-16 2011-05-10 Micromet Ag Elementos de unión a cd-3 desinmunizados multiespecíficos.
US20060051347A1 (en) * 2004-09-09 2006-03-09 Winter Charles M Process for concentration of antibodies and therapeutic products thereof
LT2520590T (lt) 2007-04-03 2018-09-10 Amgen Research (Munich) Gmbh Susijusioms rūšims specifinis rišantis domenas
CA2770235C (en) * 2009-08-06 2021-06-29 Genentech, Inc. Method to improve virus removal in protein purification
AU2010310748C1 (en) * 2009-10-20 2015-11-26 Abbvie Inc. Isolation and purification of anti-IL-13 antibodies using Protein A affinity chromatography
JP6024025B2 (ja) * 2011-05-02 2016-11-09 イミューノメディクス、インコーポレイテッドＩｍｍｕｎｏｍｅｄｉｃｓ， Ｉｎｃ． 少容量投与用のアロタイプ選択抗体の限外濾過濃縮
EP2820047B1 (en) 2012-03-01 2018-04-25 Amgen Research (Munich) GmbH Long life polypeptide binding molecules
AU2013343638B2 (en) * 2012-11-06 2018-08-30 Amgen, Inc. Formulation for bispecific T-cell engagers (BITES)
AR095596A1 (es) 2013-03-15 2015-10-28 Amgen Res (Munich) Gmbh Moléculas de unión de cadena única comprendiendo n-terminal abp
AU2014236769B2 (en) 2013-03-15 2018-09-27 Amgen Inc. Heterodimeric bispecific antibodies
US20140308285A1 (en) 2013-03-15 2014-10-16 Amgen Inc. Heterodimeric bispecific antibodies
US20140302037A1 (en) 2013-03-15 2014-10-09 Amgen Inc. BISPECIFIC-Fc MOLECULES
EP3733710A1 (en) 2013-09-25 2020-11-04 Amgen, Inc Hetrodimeric v-c-fc-v-c antibody
WO2016005903A2 (en) * 2014-07-08 2016-01-14 Theramyt Novobiologics Private Limited A process for obtaining exendin-4
CA2999118C (en) * 2015-09-22 2022-06-14 Pfizer Inc. Method of preparing a therapeutic protein formulation and antibody formulation produced by such a method
WO2017072201A2 (en) * 2015-10-26 2017-05-04 Lonza Limited A manufacturing facility for the production of biopharmaceuticals
EA039859B1 (ru) 2016-02-03 2022-03-21 Эмджен Рисерч (Мюник) Гмбх Биспецифические конструкты антител, связывающие egfrviii и cd3
EP3472177B1 (en) * 2016-06-17 2024-08-14 F. Hoffmann-La Roche AG Purification of multispecific antibodies
KR102572453B1 (ko) * 2017-02-16 2023-08-29 코메라 라이프 사이언시스, 인코포레이티드 단백질 가공 처리를 위한 부형제 화합물
EP3601338A4 (en) * 2017-03-29 2020-12-16 Celgene Corporation FORMULATIONS INCLUDING PROTEINS BINDING PD-1 AND THEIR PREPARATION METHODS
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Also Published As

Publication number Publication date
IL284782A (en) 2021-08-31
TW202043253A (zh) 2020-12-01
CL2023001293A1 (es) 2023-10-06
AR117896A1 (es) 2021-09-01
CL2021001958A1 (es) 2022-01-28
EP3917494A1 (en) 2021-12-08
WO2020159838A1 (en) 2020-08-06
CN118994410A (zh) 2024-11-22
KR20210120032A (ko) 2021-10-06
US20220119526A1 (en) 2022-04-21
CN113382716A (zh) 2021-09-10
BR112021014634A2 (pt) 2021-10-26
CA3127258A1 (en) 2020-08-06
JP2025028874A (ja) 2025-03-05
EA202192108A1 (ru) 2021-10-21
AU2020216108A1 (en) 2021-08-12
JP2022523025A (ja) 2022-04-21
JP7617004B2 (ja) 2025-01-17
SG11202107714VA (en) 2021-08-30

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