[go: up one dir, main page]

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)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (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)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (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 (16)

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 (2) AU2020216108B2 (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)
TW (1) TWI871300B (es)
WO (1) WO2020159838A1 (es)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113825840A (zh) * 2019-04-03 2021-12-21 建新公司 重组蛋白的连续生产
MX2021013220A (es) 2019-05-03 2021-12-10 Genentech Inc Metodos para reducir la tasa de actividad de hidrolisis enzimatica en una composicion obtenida de una plataforma de purificacion.
CA3156683A1 (en) * 2019-11-13 2021-05-20 Amgen Inc. METHOD FOR REDUCING AGGREGATE FORMATION IN DOWNSTREAM PROCESSING OF BI-SPECIFIC ANTIGEN-BINDING MOLECULES
KR20220129003A (ko) * 2020-01-15 2022-09-22 에프. 호프만-라 로슈 아게 재조합 단백질 제조 공정으로부터 불순물을 감소시키기 위한 방법
AU2021262609A1 (en) * 2020-05-01 2022-12-22 Kashiv Biosciences, Llc An improved process of purification of protein
EP4584363A1 (en) 2022-09-06 2025-07-16 Amgen Inc. Lean perfusion cell culture methods
AU2023340945A1 (en) 2022-09-16 2025-03-13 Amgen Inc. A method for harvesting products from perfusion cultures
CN120826269A (zh) 2023-03-13 2025-10-21 安进公司 使用超大病毒预过滤器的病毒过滤操作
TW202500572A (zh) 2023-03-14 2025-01-01 美商安進公司 使用一級胺配體的陰離子交換層析製程
AU2024313665A1 (en) 2023-06-20 2025-12-11 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
WO2025193791A1 (en) * 2024-03-14 2025-09-18 Amgen Inc. Intensified ultrafiltration/diafiltration processes
KR102790037B1 (ko) 2024-04-11 2025-04-04 주식회사 보부상바이오팜 인공지능 모델 기반 타정성 최적화를 위한 건강기능식품 원료 배합 및 환경 제어 최적화 방법, 장치 및 시스템

Family Cites Families (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
CA2326389C (en) 1998-04-21 2007-01-23 Micromet Gesellschaft Fur Biomedizinische Forschung Mbh Novel cd19xcd3 specific polypeptides and uses thereof
NZ546173A (en) 2003-10-16 2009-04-30 Micromet Ag Multispecific deimmunized CD3-binders
US20060051347A1 (en) * 2004-09-09 2006-03-09 Winter Charles M Process for concentration of antibodies and therapeutic products thereof
CN103694350B (zh) 2007-04-03 2018-04-24 安进研发（慕尼黑）股份有限公司 跨物种特异性CD3-ε结合结构域
KR20180035936A (ko) 2009-08-06 2018-04-06 제넨테크, 인크. 단백질 정제 시의 바이러스 제거의 개선방법
RS60577B1 (sr) 2009-10-20 2020-08-31 Abbvie Inc Izolacija i prečišćavanje anti-il-13 antitela upotrebom protein a afinitetne hromatografije
AU2012250924B2 (en) * 2011-05-02 2017-05-25 Immunomedics, Inc. Ultrafiltration concentration of allotype selected antibodies for small-volume administration
JP6407726B2 (ja) 2012-03-01 2018-10-24 アムゲン リサーチ （ミュンヘン） ゲーエムベーハーＡＭＧＥＮ Ｒｅｓｅａｒｃｈ（Ｍｕｎｉｃｈ）ＧｍｂＨ 長寿命ポリペプチド結合分子
WO2014072277A1 (de) 2012-11-06 2014-05-15 Bayer Pharma Aktiengesellschaft Formulierung für bispecific t-cell-engangers (bites)
WO2014151878A2 (en) * 2013-03-14 2014-09-25 Abbvie Inc. Methods for modulating protein glycosylation profiles of recombinant protein therapeutics using monosaccharides and oligosacharides
US20140302037A1 (en) 2013-03-15 2014-10-09 Amgen Inc. BISPECIFIC-Fc MOLECULES
US20140308285A1 (en) 2013-03-15 2014-10-16 Amgen Inc. Heterodimeric bispecific antibodies
MX357011B (es) 2013-03-15 2018-06-22 Amgen Inc Anticuerpos biespecificos heterodimericos.
US20160122436A1 (en) 2013-03-15 2016-05-05 Amgen Research (Munich) Gmbh Single chain binding molecules comprising n-terminal abp
EP3049440B1 (en) 2013-09-25 2020-03-25 Amgen Inc. V-c-fc-v-c antibody
WO2016005903A2 (en) * 2014-07-08 2016-01-14 Theramyt Novobiologics Private Limited A process for obtaining exendin-4
EA039859B1 (ru) * 2015-07-31 2022-03-21 Эмджен Рисерч (Мюник) Гмбх Биспецифические конструкты антител, связывающие egfrviii и cd3
GB2542391A (en) * 2015-09-17 2017-03-22 Annexin Pharmaceuticals Ab Process of manufacture
WO2017051273A1 (en) 2015-09-22 2017-03-30 Pfizer Inc. Method of preparing a therapeutic protein formulation and antibody formulation produced by such a method
KR20180074775A (ko) * 2015-10-26 2018-07-03 론자 리미티드 생물약제의 생산을 위한 제조 설비
HRP20241323T1 (hr) * 2016-06-17 2024-12-20 F. Hoffmann - La Roche Ag Pročišćavanje multispecifičnih protutijela
EP3582801A4 (en) 2017-02-16 2020-12-23 Reform Biologics LLC EXCIPIENT COMPOUNDS INTENDED FOR PROTEIN TREATMENT
MX2019010999A (es) 2017-03-29 2020-02-05 Celgene Corp Formulaciones que comprenden proteinas de union a pd-1 y metodos para preparar las mismas.
CA3066062C (en) 2017-06-12 2023-02-14 Asahi Kasei Medical Co., Ltd. Method for filtering protein-containing liquid
EA202091422A1 (ru) 2017-12-11 2020-08-28 Эмджен Инк. Способ непрерывного производства продуктов на основе биспецифических антител

Also Published As

Publication number Publication date
CA3127258A1 (en) 2020-08-06
TW202043253A (zh) 2020-12-01
JP2022523025A (ja) 2022-04-21
AU2020216108B2 (en) 2025-07-03
SG11202107714VA (en) 2021-08-30
WO2020159838A1 (en) 2020-08-06
CN113382716A (zh) 2021-09-10
EA202192108A1 (ru) 2021-10-21
AR117896A1 (es) 2021-09-01
JP2025028874A (ja) 2025-03-05
AU2025238136A1 (en) 2025-10-23
CL2023001293A1 (es) 2023-10-06
EP3917494A1 (en) 2021-12-08
JP7617004B2 (ja) 2025-01-17
BR112021014634A2 (pt) 2021-10-26
CL2021001958A1 (es) 2022-01-28
AU2020216108A1 (en) 2021-08-12
IL284782A (en) 2021-08-31
CN118994410A (zh) 2024-11-22
US20220119526A1 (en) 2022-04-21
KR20210120032A (ko) 2021-10-06
TWI871300B (zh) 2025-02-01

Similar Documents

Publication Publication Date Title
MX2021008985A (es) Procedimiento de fabricacion continuo para la fabricacion de productos biologicos mediante integracion de procedimientos de principio activo y producto terminado.
CO2022002637A2 (es) Proceso de fabricación de moduladores de cftr
EP4083007A4 (en) PROCESS FOR PRODUCING 1,3-BUTYLENE GLYCOL AND 1,3-BUTYLENE GLYCOL PRODUCT
EP4470593A3 (en) Hydrophilic medical products and hydration mediums for hydrating the same
EP3522271A4 (en) NEGATIVE ELECTRODE ACTIVE MATERIAL, MIXED NEGATIVE ELECTRODE ACTIVE MATERIAL SUBSTANCE, AND METHOD FOR PRODUCING A NEGATIVE ELECTRODE ACTIVE MATERIAL
EP3546113A4 (en) SOLDER PLATE AND PRODUCTION METHOD THEREFOR
MX2021014747A (es) Sistemas y metodos para sintetizar productos quimicos, incluyendo ingredientes farmaceuticos activos.
EP3467912A4 (en) NEGATIVE ELECTRODE ACTIVE MATERIAL, MIXED NEGATIVE ELECTRODE ACTIVE MATERIAL AND METHOD FOR PRODUCING A NEGATIVE ELECTRODE ACTIVE MATERIAL
EP3467911A4 (en) NEGATIVE ELECTRODE ACTIVE MATERIAL, MIXED NEGATIVE ELECTRODE ACTIVE MATERIAL AND METHOD FOR PRODUCING A NEGATIVE ELECTRODE ACTIVE MATERIAL
EP3536836A4 (en) TISSUE, METHOD FOR THE MANUFACTURE THEREOF AND FIBROUS PRODUCT
EP3467913A4 (en) NEGATIVE ELECTRODE ACTIVE MATERIAL, MIXED NEGATIVE ELECTRODE ACTIVE MATERIAL AND METHOD FOR PRODUCING A NEGATIVE ELECTRODE ACTIVE MATERIAL
BR112012008739A2 (pt) Produtos de tabaco úmido sem combustão com revestimento de gel estruturado em rede para uso oral e métodos de fabricação
CL2020000768A1 (es) Producción a gran escala de productos líquidos y sólidos de trichoderma.
CO2017012395A2 (es) Producto absorbente que comprende material de entrada
EP3447829A4 (en) NEGATIVE ELECTRODE ACTIVE SUBSTANCE, MIXED NEGATIVE ELECTRODE ACTIVE SUBSTANCE MATERIAL AND METHOD FOR PRODUCING A NEGATIVE ELECTRODE ACTIVE SUBSTANCE
WO2016193924A3 (en) System of multiple bags and method for the preparation of hemocomponents
EP3521417A4 (en) METHOD FOR THE PRODUCTION OF CELL TISSUE AND POROUS FILM
EP3444027A4 (en) MICRO-REACTOR, MOLD PRODUCT PRODUCTION SYSTEM AND MICRO-REACTOR MANUFACTURING METHOD
BR112018008769A2 (pt) formulações farmacêuticas, formulações líquidas aquosa reconstituída e liofilizada, seringa, método de fabricação de uma formulação farmacêutica, método para tratamento de uma doença e uso de uma formulação reconstruída
NI202000044S (es) Bandejas de fabricación
AU2017262630A1 (en) Method for the production of molded bodies for administration to animals
EP3854476A4 (en) CATALYST AND PROCESS FOR THE PREPARATION OF 1,3-BUTADIENE USING THE SAME
MX378309B (es) Sistemas y métodos para fabricar receptáculos para productos alimenticios vegetales
MX386828B (es) Procedimiento y nuevos productos intermedios para la preparación de 11-metilen-esteroides.
PT3348145T (pt) Método e sistema para o fabrico de produtos à base de massa