CA2988366C - Methods for improving the adsorption of polysaccharide-protein conjugates and multivalent vaccine formulation obtained thereof. - Google Patents
Methods for improving the adsorption of polysaccharide-protein conjugates and multivalent vaccine formulation obtained thereof. Download PDFInfo
- Publication number
- CA2988366C CA2988366C CA2988366A CA2988366A CA2988366C CA 2988366 C CA2988366 C CA 2988366C CA 2988366 A CA2988366 A CA 2988366A CA 2988366 A CA2988366 A CA 2988366A CA 2988366 C CA2988366 C CA 2988366C
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- Prior art keywords
- polysaccharide
- serotype
- protein
- conjugated
- adsorption
- Prior art date
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- 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
-
- 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
- A61K39/02—Bacterial antigens
- A61K39/085—Staphylococcus
-
- 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
- A61K39/02—Bacterial antigens
- A61K39/09—Lactobacillales, e.g. aerococcus, enterococcus, lactobacillus, lactococcus, streptococcus
-
- 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
- A61K39/02—Bacterial antigens
- A61K39/09—Lactobacillales, e.g. aerococcus, enterococcus, lactobacillus, lactococcus, streptococcus
- A61K39/092—Streptococcus
-
- 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
- A61K39/02—Bacterial antigens
- A61K39/116—Polyvalent bacterial antigens
-
- 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
- A61K39/39—Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- 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
- A61K47/6415—Toxins or lectins, e.g. clostridial toxins or Pseudomonas exotoxins
-
- 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
- A61K47/646—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 the entire peptide or protein drug conjugate elicits an immune response, e.g. conjugate vaccines
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
-
- 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
- A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
-
- 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
- A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
- A61K2039/55505—Inorganic adjuvants
-
- 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
- A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
- A61K2039/55511—Organic adjuvants
- A61K2039/55516—Proteins; Peptides
-
- 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
- A61K2039/60—Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
- A61K2039/6031—Proteins
- A61K2039/6037—Bacterial toxins, e.g. diphteria toxoid [DT], tetanus toxoid [TT]
-
- 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
- A61K2039/70—Multivalent vaccine
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Immunology (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Oncology (AREA)
- Organic Chemistry (AREA)
- Communicable Diseases (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Toxicology (AREA)
- Inorganic Chemistry (AREA)
- Virology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IN2185MU2015 | 2015-06-08 | ||
| IN2185/MUM/2015 | 2015-06-08 | ||
| PCT/IB2016/053265 WO2016199003A1 (en) | 2015-06-08 | 2016-06-03 | Methods for improving the adsorption of polysaccharide-protein conjugates and multivalent vaccine formulation obtained thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2988366A1 CA2988366A1 (en) | 2016-12-15 |
| CA2988366C true CA2988366C (en) | 2021-12-07 |
Family
ID=57503115
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2988366A Active CA2988366C (en) | 2015-06-08 | 2016-06-03 | Methods for improving the adsorption of polysaccharide-protein conjugates and multivalent vaccine formulation obtained thereof. |
Country Status (17)
| Country | Link |
|---|---|
| US (1) | US10729780B2 (enExample) |
| EP (1) | EP3302542A4 (enExample) |
| JP (2) | JP7258463B2 (enExample) |
| KR (2) | KR102690378B1 (enExample) |
| CN (1) | CN107847571A (enExample) |
| AU (2) | AU2016276269B2 (enExample) |
| CA (1) | CA2988366C (enExample) |
| CO (1) | CO2017012628A2 (enExample) |
| EA (1) | EA201792470A1 (enExample) |
| IL (1) | IL256118B (enExample) |
| MX (1) | MX2017015985A (enExample) |
| MY (1) | MY187461A (enExample) |
| PE (1) | PE20180460A1 (enExample) |
| PH (1) | PH12017502244A1 (enExample) |
| SA (1) | SA517390495B1 (enExample) |
| WO (1) | WO2016199003A1 (enExample) |
| ZA (1) | ZA201708325B (enExample) |
Families Citing this family (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR102045663B1 (ko) | 2015-05-04 | 2019-11-15 | 화이자 인코포레이티드 | B군 스트렙토코쿠스 폴리사카라이드-단백질 접합체, 접합체를 생산하는 방법, 접합체를 포함하는 면역원성 조성물, 및 그의 용도 |
| PE20180460A1 (es) * | 2015-06-08 | 2018-03-06 | Serum Inst Of India Private Ltd | Metodos para mejorar la adsorcion de conjugados de polisacarido-proteina y una formulacion de vacuna multivalente obtenida con los mismos |
| CN106822884B (zh) * | 2016-12-28 | 2021-04-30 | 北京民海生物科技有限公司 | 一种多价肺炎球菌荚膜多糖结合疫苗的制备方法 |
| US11951165B2 (en) | 2016-12-30 | 2024-04-09 | Vaxcyte, Inc. | Conjugated vaccine carrier proteins |
| MX2019007910A (es) | 2016-12-30 | 2019-12-05 | Sutrovax Inc | Conjugados de polipeptido-antigeno con aminoacidos no naturales. |
| US20200054740A1 (en) * | 2017-02-24 | 2020-02-20 | Merck Sharp & Dohme Corp. | Pneumococcal conjugate vaccine formulations |
| US10729763B2 (en) | 2017-06-10 | 2020-08-04 | Inventprise, Llc | Mixtures of polysaccharide-protein pegylated compounds |
| US11491216B2 (en) * | 2017-09-07 | 2022-11-08 | Merck Sharp & Dohme Llc | Pneumococcal polysaccharides and their use in immunogenic polysaccharide-carrier protein conjugates |
| US11116828B2 (en) | 2017-12-06 | 2021-09-14 | Merck Sharp & Dohme Corp. | Compositions comprising Streptococcus pneumoniae polysaccharide-protein conjugates and methods of use thereof |
| CN108524926B (zh) * | 2018-06-29 | 2021-06-29 | 康希诺生物股份公司 | 一种多价肺炎球菌结合疫苗的制剂组合及其应用 |
| GB201818517D0 (en) * | 2018-11-13 | 2018-12-26 | Univ Liverpool John Moores | Nanoparticles and uses thereof |
| BR112021011961A8 (pt) | 2018-12-19 | 2023-02-07 | Merck Sharp & Dohme | Composições compreendendo conjugados de polissacarídeo-proteína de streptococcus pneumoniae e métodos de uso dos mesmos |
| CA3142692A1 (en) * | 2019-06-05 | 2020-12-10 | Merck Sharp & Dohme Corp. | An immunogenic serotype 35b pneumococcal polysaccharide-protein conjugate and conjugation process for making the same |
| US12473379B2 (en) | 2019-09-06 | 2025-11-18 | Serum Institute Of India Private Limited | Method for obtaining purified bacterial polysaccharides |
| CN113607939B (zh) * | 2021-08-05 | 2024-10-22 | 艾美探索者生命科学研发有限公司 | 肺炎球菌多糖结合疫苗各型结合原液吸附率测定方法 |
| CN115006522B (zh) * | 2022-06-16 | 2025-08-22 | 北京智飞绿竹生物制药有限公司 | 一种双价痢疾结合物组合疫苗的制备方法 |
| MX2024004116A (es) | 2023-04-17 | 2024-11-08 | Serum Institute Of India Pvt Ltd | Metodos para mejorar la adsorcion de conjugados de polisacarido-proteina y formulacion de vacuna multivalente obtenida de los mismos |
Family Cites Families (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2059692C (en) * | 1991-01-28 | 2004-11-16 | Peter J. Kniskern | Pneumoccoccal polysaccharide conjugate vaccine |
| ES2411080T3 (es) * | 2003-01-30 | 2013-07-04 | Novartis Ag | Vacunas inyectables contra múltiples serogrupos de meningococos |
| CN102151331B (zh) | 2003-08-06 | 2013-10-30 | 美国政府健康及人类服务部 | 多糖-蛋白轭合物疫苗 |
| WO2006113528A2 (en) * | 2005-04-18 | 2006-10-26 | Novartis Vaccines And Diagnostics Inc. | Expressing hepatitis b virus surface antigen for vaccine preparation |
| DK2384765T3 (en) * | 2005-12-22 | 2017-01-09 | Glaxosmithkline Biologicals Sa | Vaccine against Streptococcus pneumoniae. |
| KR20080079697A (ko) * | 2005-12-23 | 2008-09-01 | 글락소스미스클라인 바이오로지칼즈 에스.에이. | 컨쥬게이트 백신 |
| TW200806315A (en) * | 2006-04-26 | 2008-02-01 | Wyeth Corp | Novel formulations which stabilize and inhibit precipitation of immunogenic compositions |
| PL2167121T3 (pl) * | 2007-06-26 | 2016-01-29 | Glaxosmithkline Biologicals Sa | Szczepionka zawierająca koniugaty polisacharydu otoczkowego streptococcus pneumoniae |
| TW201136603A (en) | 2010-02-09 | 2011-11-01 | Merck Sharp & Amp Dohme Corp | 15-valent pneumococcal polysaccharide-protein conjugate vaccine composition |
| CN103391714A (zh) * | 2010-12-10 | 2013-11-13 | 默沙东公司 | 减轻搅动引起的免疫原性组合物聚集的新制剂 |
| SI2809349T1 (sl) * | 2012-01-30 | 2019-03-29 | Serum Institute Of India Private Limited | Imunogeni sestavek |
| KR102057217B1 (ko) * | 2012-06-20 | 2020-01-22 | 에스케이바이오사이언스 주식회사 | 다가 폐렴구균 다당류-단백질 접합체 조성물 |
| CA2881420C (en) * | 2012-08-16 | 2016-11-15 | Pfizer Inc. | Glycoconjugation processes and compositions |
| CN103893751B (zh) * | 2014-03-26 | 2016-04-20 | 天津康希诺生物技术有限公司 | 一种肺炎球菌多糖蛋白缀合疫苗及其制备方法 |
| PE20180460A1 (es) * | 2015-06-08 | 2018-03-06 | Serum Inst Of India Private Ltd | Metodos para mejorar la adsorcion de conjugados de polisacarido-proteina y una formulacion de vacuna multivalente obtenida con los mismos |
-
2016
- 2016-06-03 PE PE2017002539A patent/PE20180460A1/es unknown
- 2016-06-03 EA EA201792470A patent/EA201792470A1/ru unknown
- 2016-06-03 MX MX2017015985A patent/MX2017015985A/es unknown
- 2016-06-03 KR KR1020187000352A patent/KR102690378B1/ko active Active
- 2016-06-03 JP JP2017564108A patent/JP7258463B2/ja active Active
- 2016-06-03 EP EP16806975.5A patent/EP3302542A4/en active Pending
- 2016-06-03 US US15/580,653 patent/US10729780B2/en active Active
- 2016-06-03 WO PCT/IB2016/053265 patent/WO2016199003A1/en not_active Ceased
- 2016-06-03 MY MYPI2017704714A patent/MY187461A/en unknown
- 2016-06-03 KR KR1020237045298A patent/KR102876828B1/ko active Active
- 2016-06-03 AU AU2016276269A patent/AU2016276269B2/en active Active
- 2016-06-03 CN CN201680040596.5A patent/CN107847571A/zh active Pending
- 2016-06-03 CA CA2988366A patent/CA2988366C/en active Active
-
2017
- 2017-12-05 IL IL256118A patent/IL256118B/en unknown
- 2017-12-07 PH PH12017502244A patent/PH12017502244A1/en unknown
- 2017-12-07 CO CONC2017/0012628A patent/CO2017012628A2/es unknown
- 2017-12-07 ZA ZA2017/08325A patent/ZA201708325B/en unknown
- 2017-12-10 SA SA517390495A patent/SA517390495B1/ar unknown
-
2021
- 2021-08-06 JP JP2021129726A patent/JP2021185152A/ja active Pending
-
2024
- 2024-04-15 AU AU2024202450A patent/AU2024202450A1/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| EP3302542A1 (en) | 2018-04-11 |
| KR20180030498A (ko) | 2018-03-23 |
| CA2988366A1 (en) | 2016-12-15 |
| KR102876828B1 (ko) | 2025-10-27 |
| CO2017012628A2 (es) | 2018-03-28 |
| MX2017015985A (es) | 2018-08-15 |
| IL256118A (en) | 2018-02-28 |
| CN107847571A (zh) | 2018-03-27 |
| EP3302542A4 (en) | 2019-04-10 |
| EA201792470A1 (ru) | 2018-10-31 |
| US10729780B2 (en) | 2020-08-04 |
| JP2021185152A (ja) | 2021-12-09 |
| SA517390495B1 (ar) | 2023-03-23 |
| ZA201708325B (en) | 2019-05-29 |
| NZ738090A (en) | 2023-09-29 |
| AU2016276269B2 (en) | 2021-01-28 |
| KR102690378B1 (ko) | 2024-08-01 |
| PE20180460A1 (es) | 2018-03-06 |
| IL256118B (en) | 2021-12-01 |
| AU2024202450A1 (en) | 2024-10-31 |
| KR20240007690A (ko) | 2024-01-16 |
| JP7258463B2 (ja) | 2023-04-17 |
| AU2016276269A1 (en) | 2018-01-18 |
| BR112017026343A2 (pt) | 2019-11-19 |
| US20180161445A1 (en) | 2018-06-14 |
| JP2018516962A (ja) | 2018-06-28 |
| PH12017502244A1 (en) | 2018-06-11 |
| MY187461A (en) | 2021-09-23 |
| WO2016199003A1 (en) | 2016-12-15 |
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