CL2016001741A1 - Método de purificación de conjugados de anticuerpo-fármaco adc mediante cromatografía de interacción hidrofóbica hic que comprende obtener una mezcla de adc en una solución acuosa de sal de 0,2 a 1,5 m, cargar en una columna de hic, recolectar fracción no unida, lavar, y eluir con una solución acuosa de sal de 0 a 0,1 m. - Google Patents
Método de purificación de conjugados de anticuerpo-fármaco adc mediante cromatografía de interacción hidrofóbica hic que comprende obtener una mezcla de adc en una solución acuosa de sal de 0,2 a 1,5 m, cargar en una columna de hic, recolectar fracción no unida, lavar, y eluir con una solución acuosa de sal de 0 a 0,1 m.Info
- Publication number
- CL2016001741A1 CL2016001741A1 CL2016001741A CL2016001741A CL2016001741A1 CL 2016001741 A1 CL2016001741 A1 CL 2016001741A1 CL 2016001741 A CL2016001741 A CL 2016001741A CL 2016001741 A CL2016001741 A CL 2016001741A CL 2016001741 A1 CL2016001741 A1 CL 2016001741A1
- Authority
- CL
- Chile
- Prior art keywords
- hic
- adc
- antibody
- aqueous
- salt
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title abstract 4
- 239000012266 salt solution Substances 0.000 title abstract 3
- 239000007864 aqueous solution Substances 0.000 title abstract 2
- 238000004191 hydrophobic interaction chromatography Methods 0.000 title abstract 2
- 238000000034 method Methods 0.000 title abstract 2
- 238000000746 purification Methods 0.000 title abstract 2
- 150000003839 salts Chemical class 0.000 title abstract 2
- 229940125644 antibody drug Drugs 0.000 title 1
- 239000000611 antibody drug conjugate Substances 0.000 abstract 2
- 229940049595 antibody-drug conjugate Drugs 0.000 abstract 2
- XUJNEKJLAYXESH-UHFFFAOYSA-N cysteine Natural products SCC(N)C(O)=O XUJNEKJLAYXESH-UHFFFAOYSA-N 0.000 abstract 2
- 235000018417 cysteine Nutrition 0.000 abstract 2
- 239000003960 organic solvent Substances 0.000 abstract 1
- 239000000243 solution Substances 0.000 abstract 1
Classifications
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- 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
-
- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/68—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
- A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
- A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
- A61K31/223—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin of alpha-aminoacids
-
- 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
- A61K39/44—Antibodies bound to carriers
-
- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/62—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
- A61K47/64—Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
-
- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/68—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
- A61K47/6835—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
- A61K47/6851—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a determinant of a tumour cell
-
- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/68—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
- A61K47/6889—Conjugates wherein the antibody being the modifying agent and wherein the linker, binder or spacer confers particular properties to the conjugates, e.g. peptidic enzyme-labile linkers or acid-labile linkers, providing for an acid-labile immuno conjugate wherein the drug may be released from its antibody conjugated part in an acidic, e.g. tumoural or environment
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
- B01D15/08—Selective adsorption, e.g. chromatography
- B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
- B01D15/32—Bonded phase chromatography
- B01D15/325—Reversed phase
- B01D15/327—Reversed phase with hydrophobic interaction
-
- 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
- C07K1/16—Extraction; Separation; Purification by chromatography
- C07K1/20—Partition-, reverse-phase or hydrophobic interaction chromatography
-
- 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
- C07K16/32—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Immunology (AREA)
- Organic Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Cell Biology (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Oncology (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Emergency Medicine (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
Abstract
Se describe un método de purificación de una mezcla de conjugados de anticuerpo-fármaco con cisteína enlazada de fórmula I en que la cantidad de anticuerpo no conjugado está en el rango de 10 a 40 en peso, que comprende a obtener una mezcla en una solución acuosa de sal de 0,2 a 1,5 M b cargar dicha solución en una columna preparativa de cromatografía de interacción hidrofóbica c recolectar una fracción circulante que contenga anticuerpo no conjugado d lavar dicha columna con una solución acuosa de sal de 0,2 a 1,5 M mientras se recolecta la fracción circulante y e eluir dicha columna con una solución acuosa de sal de 0 a 100 mM para así obtener una mezcla purificada de conjugados anticuerpo-fármaco con cisteína enlazada en el que no se utiliza disolvente orgánico añadido en las etapas a, b, d ó e.
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP14150789 | 2014-01-10 |
Publications (1)
Publication Number | Publication Date |
---|---|
CL2016001741A1 true CL2016001741A1 (es) | 2017-05-12 |
Family
ID=49911439
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CL2016001741A CL2016001741A1 (es) | 2014-01-10 | 2016-07-07 | Método de purificación de conjugados de anticuerpo-fármaco adc mediante cromatografía de interacción hidrofóbica hic que comprende obtener una mezcla de adc en una solución acuosa de sal de 0,2 a 1,5 m, cargar en una columna de hic, recolectar fracción no unida, lavar, y eluir con una solución acuosa de sal de 0 a 0,1 m. |
Country Status (22)
Country | Link |
---|---|
US (1) | US10266606B2 (es) |
EP (1) | EP3092010B1 (es) |
JP (1) | JP6419844B2 (es) |
KR (1) | KR102323301B1 (es) |
CN (1) | CN105899235B (es) |
AU (1) | AU2015205574B2 (es) |
CA (1) | CA2935456C (es) |
CL (1) | CL2016001741A1 (es) |
CY (1) | CY1120595T1 (es) |
DK (1) | DK3092010T3 (es) |
ES (1) | ES2687225T3 (es) |
HR (1) | HRP20181525T1 (es) |
LT (1) | LT3092010T (es) |
MX (1) | MX2016009068A (es) |
MY (1) | MY177390A (es) |
PL (1) | PL3092010T3 (es) |
PT (1) | PT3092010T (es) |
RU (1) | RU2680404C2 (es) |
SG (1) | SG11201605605SA (es) |
TR (1) | TR201810856T4 (es) |
WO (1) | WO2015104359A2 (es) |
ZA (1) | ZA201604531B (es) |
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US9901567B2 (en) | 2007-08-01 | 2018-02-27 | Syntarga B.V. | Substituted CC-1065 analogs and their conjugates |
NO3056203T3 (es) | 2010-04-21 | 2018-05-12 | ||
ES2687225T3 (es) | 2014-01-10 | 2018-10-24 | Synthon Biopharmaceuticals B.V. | Método de purificación de conjugados anticuerpo-fármaco unidos a Cys |
SG11201605597VA (en) | 2014-01-10 | 2016-08-30 | Synthon Biopharmaceuticals Bv | Duocarmycin adcs for use in treatment of endometrial cancer |
AU2015205509B2 (en) | 2014-01-10 | 2019-08-15 | Byondis B.V. | Duocarmycin ADCs showing improved in vivo antitumor activity |
JP6517240B2 (ja) | 2014-05-22 | 2019-05-22 | シントン・バイオファーマシューティカルズ・ビー.ブイ.Synthon Biopharmaceuticals B.V. | 抗体へのリンカー薬物の部位特異的コンジュゲーションおよび得られるadc |
PL3152191T3 (pl) | 2014-06-05 | 2019-10-31 | Synthon Biopharmaceuticals Bv | Ulepszony sposób wytwarzania proleków duokarmycyny |
CN108026170B (zh) | 2015-05-04 | 2022-03-01 | 西托姆克斯治疗公司 | 抗cd71抗体、可活化抗cd71抗体及其使用方法 |
EP3442574A4 (en) | 2016-04-15 | 2019-12-11 | MacroGenics, Inc. | NOVEL B7-H3 BINDING MOLECULES, THEIR ANTIBODY-MEDICINAL CONJUGATES AND METHODS OF USE |
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WO2020022363A1 (ja) | 2018-07-25 | 2020-01-30 | 第一三共株式会社 | 抗体-薬物コンジュゲートの効果的な製造方法 |
CN109336967A (zh) * | 2018-11-09 | 2019-02-15 | 杭州奕安济世生物药业有限公司 | 基于混合填料的抗体纯化方法 |
CN114007737B (zh) * | 2019-07-03 | 2024-07-05 | 默克专利股份公司 | 抗体药物缀合物纯化 |
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KR20160106721A (ko) | 2016-09-12 |
AU2015205574A1 (en) | 2016-07-07 |
US10266606B2 (en) | 2019-04-23 |
RU2016132634A3 (es) | 2018-09-05 |
HRP20181525T1 (hr) | 2018-11-16 |
KR102323301B1 (ko) | 2021-11-09 |
AU2015205574B2 (en) | 2019-08-15 |
WO2015104359A2 (en) | 2015-07-16 |
WO2015104359A3 (en) | 2015-09-11 |
JP2017502085A (ja) | 2017-01-19 |
DK3092010T3 (en) | 2018-08-27 |
CA2935456A1 (en) | 2015-07-16 |
EP3092010B1 (en) | 2018-07-11 |
CN105899235B (zh) | 2019-08-30 |
PT3092010T (pt) | 2018-09-28 |
MY177390A (en) | 2020-09-14 |
RU2680404C2 (ru) | 2019-02-21 |
PL3092010T3 (pl) | 2019-01-31 |
TR201810856T4 (tr) | 2018-08-27 |
CA2935456C (en) | 2018-09-18 |
LT3092010T (lt) | 2018-10-25 |
JP6419844B2 (ja) | 2018-11-07 |
RU2016132634A (ru) | 2018-02-16 |
US20160324979A1 (en) | 2016-11-10 |
SG11201605605SA (en) | 2016-08-30 |
EP3092010A2 (en) | 2016-11-16 |
CN105899235A (zh) | 2016-08-24 |
ZA201604531B (en) | 2018-07-25 |
ES2687225T3 (es) | 2018-10-24 |
MX2016009068A (es) | 2016-09-28 |
CY1120595T1 (el) | 2019-12-11 |
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