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BRPI0915696B8 - composição de vacina de rotavírus liofilizada e método de preparar a referida composição - Google Patents

composição de vacina de rotavírus liofilizada e método de preparar a referida composição

Info

Publication number
BRPI0915696B8
BRPI0915696B8 BRPI0915696A BRPI0915696A BRPI0915696B8 BR PI0915696 B8 BRPI0915696 B8 BR PI0915696B8 BR PI0915696 A BRPI0915696 A BR PI0915696A BR PI0915696 A BRPI0915696 A BR PI0915696A BR PI0915696 B8 BRPI0915696 B8 BR PI0915696B8
Authority
BR
Brazil
Prior art keywords
composition
rotavirus vaccine
preparing
vaccine
lyophilized
Prior art date
Application number
BRPI0915696A
Other languages
English (en)
Inventor
K Zade Jagdish
M Dhere Rajeev
S Pisal Sambhaji
Original Assignee
Serum Institute Of India Ltd
Serum Institute Of India Pvt Ltd
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=43356831&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BRPI0915696(B8) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Serum Institute Of India Ltd, Serum Institute Of India Pvt Ltd filed Critical Serum Institute Of India Ltd
Publication of BRPI0915696A2 publication Critical patent/BRPI0915696A2/pt
Publication of BRPI0915696B1 publication Critical patent/BRPI0915696B1/pt
Publication of BRPI0915696B8 publication Critical patent/BRPI0915696B8/pt

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/12Viral antigens
    • A61K39/15Reoviridae, e.g. calf diarrhea virus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/12Viral antigens
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N7/00Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/51Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/525Virus
    • A61K2039/5252Virus inactivated (killed)
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2720/00MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsRNA viruses
    • C12N2720/00011Details
    • C12N2720/12011Reoviridae
    • C12N2720/12311Rotavirus, e.g. rotavirus A
    • C12N2720/12334Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2720/00MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsRNA viruses
    • C12N2720/00011Details
    • C12N2720/12011Reoviridae
    • C12N2720/12311Rotavirus, e.g. rotavirus A
    • C12N2720/12351Methods of production or purification of viral material

Landscapes

  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Virology (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Medicinal Chemistry (AREA)
  • Microbiology (AREA)
  • Public Health (AREA)
  • Zoology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Mycology (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Biotechnology (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)

Abstract

composição de vacina de rotavírus liofilizada e método de preparar a referida composição. a presente invenção refere-se a formulações de vacina de rotavírus liofilizadas novas e métodos de sua preparação. as formulações incluem estabilizantes de vacina, resultando em uma formulação de vacina com estabilidade intensificada e perda mínima de potência. as formulações de vacina de rotavírus compreendem uma razão vantajosa de um dissacarídeo (tal como sacarose) para um aminoácido (tal como glicina). a liofilização resulta em uma formulação de vírus com 100% de preservação do vírus e umidade residual de cerca de 0,8% a 1,4%.
BRPI0915696A 2008-11-07 2009-11-06 composição de vacina de rotavírus liofilizada e método de preparar a referida composição BRPI0915696B8 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN2365MU2008 2008-11-07
IN2365/MUM/2008 2008-11-07
PCT/IN2009/000629 WO2010146598A2 (en) 2008-11-07 2009-11-06 Stable, dried rotavirus vaccine, compositions and process for preparation thereof

Publications (3)

Publication Number Publication Date
BRPI0915696A2 BRPI0915696A2 (pt) 2016-02-10
BRPI0915696B1 BRPI0915696B1 (pt) 2020-06-23
BRPI0915696B8 true BRPI0915696B8 (pt) 2021-05-25

Family

ID=43356831

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0915696A BRPI0915696B8 (pt) 2008-11-07 2009-11-06 composição de vacina de rotavírus liofilizada e método de preparar a referida composição

Country Status (4)

Country Link
US (1) US8795686B2 (pt)
CN (1) CN102202688B (pt)
BR (1) BRPI0915696B8 (pt)
WO (1) WO2010146598A2 (pt)

Families Citing this family (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BR112012025047A2 (pt) 2010-03-31 2016-06-21 Stabilitech Ltd formulações líquidas estabilizadas
ES2757591T3 (es) 2010-03-31 2020-04-29 Stabilitech Biopharma Ltd Estabilización de partículas virales
GB201117233D0 (en) 2011-10-05 2011-11-16 Stabilitech Ltd Stabilisation of polypeptides
AR099470A1 (es) * 2014-02-17 2016-07-27 Intervet Int Bv Vacunas de virus de aves de corral líquidas
GB201406569D0 (en) 2014-04-11 2014-05-28 Stabilitech Ltd Vaccine compositions
SG11201610920WA (en) * 2014-07-18 2017-02-27 Msd Wellcome Trust Hilleman Lab Pvt Ltd An improved thermostable spray dried rotavirus vaccine formulation and process thereof
BR112017000515A2 (pt) * 2014-07-18 2017-11-14 Msd Wellcome Trust Hilleman Laboratories Pvt Ltd formulação de vacina contra rotavírus termoestável seca por liofilização e processo para preparação da mesma
CN104524562A (zh) * 2014-12-08 2015-04-22 武汉生物制品研究所有限责任公司 口服六价重配轮状病毒活疫苗
CN104984357B (zh) * 2015-06-02 2018-01-30 长春百克生物科技股份公司 不含明胶的疫苗保护剂组合物及流感减毒活疫苗
CN106063933B (zh) * 2015-12-31 2020-01-07 武汉博沃生物科技有限公司 通用疫苗冻干保护剂及其应用
US12016949B2 (en) 2017-01-06 2024-06-25 Iosbio Ltd Virus
MY191286A (en) 2017-02-14 2022-06-14 Inventprise Llc Heat stable liquid rotavirus vaccine
US11110163B2 (en) 2017-02-14 2021-09-07 Inventprise, Llc Heat stable vaccines
GB2562241B (en) 2017-05-08 2022-04-06 Stabilitech Biopharma Ltd Vaccine compositions
CN111356760A (zh) * 2017-09-19 2020-06-30 阿德瓦希斯公司 细菌或李斯特菌菌株的冻干组合物和方法
CU24701B1 (es) 2017-10-16 2024-04-08 Serum Institute Of India Pvt Ltd Composiciones de vacuna estables que comprenden inter alia un flavivirus recombinante vivo atenuado y proceso para la preparación de las mismas
CN107744504A (zh) * 2017-10-31 2018-03-02 山东亦度生物技术有限公司 一种ma104细胞制备人用轮状病毒活疫苗的冻干工艺方法
CN111150849A (zh) * 2020-04-02 2020-05-15 广州隽沐生物科技股份有限公司 一种组合物及其制备方法及其应用
CN115531363B (zh) * 2021-06-30 2024-03-29 中国科学技术大学 预防、抑制或治疗轮状病毒感染的药物组合物及其用途

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6403098B1 (en) * 1996-09-26 2002-06-11 Merck & Co., Inc. Rotavirus vaccine formulations
US7951383B2 (en) 1997-05-23 2011-05-31 The United States Of America As Represented By The Department Of Health And Human Services Attenuated parainfluenza virus (PIV) vaccines
US20040022800A1 (en) * 2000-07-31 2004-02-05 Mark Parrington Respiratory syncytial virus vaccine
US20030092145A1 (en) 2000-08-24 2003-05-15 Vic Jira Viral vaccine composition, process, and methods of use
WO2003026642A1 (fr) 2001-09-21 2003-04-03 Sumitomo Pharmaceuticals Co., Ltd. Preparation pharmaceutique lyophilisee
AU2002951692A0 (en) * 2002-09-23 2002-10-17 Vital Biotech (Hong Kong) Limited Improvements in or relating to vaccines
US8124397B2 (en) * 2005-08-08 2012-02-28 Oregon Health & Science University Inactivating pathogens with oxidizing agents for vaccine production

Also Published As

Publication number Publication date
BRPI0915696B1 (pt) 2020-06-23
CN102202688B (zh) 2017-04-12
WO2010146598A2 (en) 2010-12-23
WO2010146598A3 (en) 2011-06-30
BRPI0915696A2 (pt) 2016-02-10
CN102202688A (zh) 2011-09-28
US20110177119A1 (en) 2011-07-21
US8795686B2 (en) 2014-08-05

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Legal Events

Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]

Free format text: NOTIFICACAO DE ANUENCIA RELACIONADA COM O ART 229 DA LPI

B25D Requested change of name of applicant approved

Owner name: SERUM INSTITUTE OF INDIA PRIVATE LIMITED (IN)

B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 10 (DEZ) ANOS CONTADOS A PARTIR DE 23/06/2020, OBSERVADAS AS CONDICOES LEGAIS.

B16C Correction of notification of the grant [chapter 16.3 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 06/11/2009 OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF