SG11202107714VA - A continuous manufacturing process for biologics manufacturing by integration of drug substance and drug product processes - Google Patents

A continuous manufacturing process for biologics manufacturing by integration of drug substance and drug product processes

Info

Publication number
SG11202107714VA
SG11202107714VA SG11202107714VA SG11202107714VA SG11202107714VA SG 11202107714V A SG11202107714V A SG 11202107714VA SG 11202107714V A SG11202107714V A SG 11202107714VA SG 11202107714V A SG11202107714V A SG 11202107714VA SG 11202107714V A SG11202107714V A SG 11202107714VA
Authority
SG
Singapore
Prior art keywords
integration
drug
biologics
manufacturing process
product processes
Prior art date
Application number
SG11202107714VA
Other languages
English (en)
Inventor
Malhar R Ambhaikar
Vincent Chai
Philip Clark
Subramanian GUHAN
Sai Chakradhar Padala
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 SG11202107714VA publication Critical patent/SG11202107714VA/en

Links

Classifications

    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • C07K16/30—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
    • 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
SG11202107714VA 2019-01-28 2020-01-27 A continuous manufacturing process for biologics manufacturing by integration of drug substance and drug product processes SG11202107714VA (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201962797445P 2019-01-28 2019-01-28
PCT/US2020/015137 WO2020159838A1 (fr) 2019-01-28 2020-01-27 Procédé de fabrication en continu pour la fabrication de produits biologiques par intégration de substances médicamenteuses et procédés de produits médicamenteux

Publications (1)

Publication Number Publication Date
SG11202107714VA true SG11202107714VA (en) 2021-08-30

Family

ID=69740575

Family Applications (1)

Application Number Title Priority Date Filing Date
SG11202107714VA SG11202107714VA (en) 2019-01-28 2020-01-27 A continuous manufacturing process for biologics manufacturing by integration of drug substance and drug product processes

Country Status (16)

Country Link
US (1) US20220119526A1 (fr)
EP (1) EP3917494A1 (fr)
JP (1) JP2022523025A (fr)
KR (1) KR20210120032A (fr)
CN (1) CN113382716A (fr)
AR (1) AR117896A1 (fr)
AU (1) AU2020216108A1 (fr)
BR (1) BR112021014634A2 (fr)
CA (1) CA3127258A1 (fr)
CL (2) CL2021001958A1 (fr)
EA (1) EA202192108A1 (fr)
IL (1) IL284782A (fr)
MX (1) MX2021008985A (fr)
SG (1) SG11202107714VA (fr)
TW (1) TW202043253A (fr)
WO (1) WO2020159838A1 (fr)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20220396599A1 (en) * 2019-11-13 2022-12-15 Amgen Inc. Method for Reduced Aggregate Formation in Downstream Processing of Bispecific Antigen-Binding Molecules
TW202140511A (zh) 2020-01-15 2021-11-01 瑞士商赫孚孟拉羅股份公司 減少來自重組蛋白生產過程中的雜質之方法
WO2024054414A1 (fr) 2022-09-06 2024-03-14 Amgen Inc. Procédés de culture de cellules sous faible perfusion
WO2024059235A2 (fr) 2022-09-16 2024-03-21 Amgen Inc. Procédé de recolte de produits à partir de cultures en perfusion

Family Cites Families (17)

* 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
AU761587B2 (en) 1998-04-21 2003-06-05 Amgen Research (Munich) Gmbh CD19xCD3 specific polypeptides and uses thereof
DE602004030811D1 (de) 2003-10-16 2011-02-10 Micromet Ag Multispezifische deimmunisierte cd3-bindende moleküle
US20060051347A1 (en) * 2004-09-09 2006-03-09 Winter Charles M Process for concentration of antibodies and therapeutic products thereof
ES2695047T3 (es) 2007-04-03 2018-12-28 Amgen Research (Munich) Gmbh Dominio de unión específico entre especies
ES2680151T3 (es) 2012-03-01 2018-09-04 Amgen Research (Munich) Gmbh Moléculas de unión de polipéptidos de larga duración
US20140308285A1 (en) 2013-03-15 2014-10-16 Amgen Inc. Heterodimeric bispecific antibodies
LT2970449T (lt) 2013-03-15 2019-11-25 Amgen Res Munich Gmbh Viengrandės surišančios molekulės, apimančios n galo abp
US20140302037A1 (en) 2013-03-15 2014-10-09 Amgen Inc. BISPECIFIC-Fc MOLECULES
US11634502B2 (en) 2013-03-15 2023-04-25 Amgen Inc. Heterodimeric bispecific antibodies
EP3049440B1 (fr) 2013-09-25 2020-03-25 Amgen Inc. Anticorps v-c-fc-v-c
WO2016005903A2 (fr) * 2014-07-08 2016-01-14 Theramyt Novobiologics Private Limited Procédé pour l'obtention d'exendine -4
KR20180037056A (ko) * 2015-09-22 2018-04-10 화이자 인코포레이티드 치료학적 단백질 제형의 제조 방법 및 이러한 방법에 의해 생산된 항체 제형
KR20180074775A (ko) * 2015-10-26 2018-07-03 론자 리미티드 생물약제의 생산을 위한 제조 설비
EA039859B1 (ru) * 2016-02-03 2022-03-21 Эмджен Рисерч (Мюник) Гмбх Биспецифические конструкты антител, связывающие egfrviii и cd3
EP3724229A1 (fr) 2017-12-11 2020-10-21 Amgen Inc. Procédé de fabrication continue pour des produits d'anticorps bispécifiques

Also Published As

Publication number Publication date
CL2021001958A1 (es) 2022-01-28
BR112021014634A2 (pt) 2021-10-26
WO2020159838A1 (fr) 2020-08-06
TW202043253A (zh) 2020-12-01
MX2021008985A (es) 2021-09-08
IL284782A (en) 2021-08-31
EP3917494A1 (fr) 2021-12-08
CN113382716A (zh) 2021-09-10
JP2022523025A (ja) 2022-04-21
AU2020216108A1 (en) 2021-08-12
AR117896A1 (es) 2021-09-01
CA3127258A1 (fr) 2020-08-06
EA202192108A1 (ru) 2021-10-21
CL2023001293A1 (es) 2023-10-06
US20220119526A1 (en) 2022-04-21
KR20210120032A (ko) 2021-10-06

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