EA202190319A1 - Композиции и способы детектирования биологического загрязнителя - Google Patents
Композиции и способы детектирования биологического загрязнителяInfo
- Publication number
- EA202190319A1 EA202190319A1 EA202190319A EA202190319A EA202190319A1 EA 202190319 A1 EA202190319 A1 EA 202190319A1 EA 202190319 A EA202190319 A EA 202190319A EA 202190319 A EA202190319 A EA 202190319A EA 202190319 A1 EA202190319 A1 EA 202190319A1
- Authority
- EA
- Eurasian Patent Office
- Prior art keywords
- compositions
- methods
- detecting biological
- biological pollutants
- pcr
- Prior art date
Links
- 238000000034 method Methods 0.000 title abstract 2
- 239000000203 mixture Substances 0.000 title abstract 2
- 239000003344 environmental pollutant Substances 0.000 title 1
- 230000003321 amplification Effects 0.000 abstract 1
- 238000001514 detection method Methods 0.000 abstract 1
- 239000003814 drug Substances 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 239000012569 microbial contaminant Substances 0.000 abstract 1
- 238000003199 nucleic acid amplification method Methods 0.000 abstract 1
- 239000013612 plasmid Substances 0.000 abstract 1
- 238000003752 polymerase chain reaction Methods 0.000 abstract 1
- 239000013641 positive control Substances 0.000 abstract 1
- 238000003753 real-time PCR Methods 0.000 abstract 1
- 238000011897 real-time detection Methods 0.000 abstract 1
- 239000000523 sample Substances 0.000 abstract 1
- 229940124597 therapeutic agent Drugs 0.000 abstract 1
Classifications
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/70—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving virus or bacteriophage
- C12Q1/701—Specific hybridization probes
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
- C12Q1/6876—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q2563/00—Nucleic acid detection characterized by the use of physical, structural and functional properties
- C12Q2563/107—Nucleic acid detection characterized by the use of physical, structural and functional properties fluorescence
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q2600/00—Oligonucleotides characterized by their use
- C12Q2600/158—Expression markers
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q2600/00—Oligonucleotides characterized by their use
- C12Q2600/166—Oligonucleotides used as internal standards, controls or normalisation probes
Landscapes
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Organic Chemistry (AREA)
- Health & Medical Sciences (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Zoology (AREA)
- Wood Science & Technology (AREA)
- Engineering & Computer Science (AREA)
- Immunology (AREA)
- Analytical Chemistry (AREA)
- Molecular Biology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biotechnology (AREA)
- Biophysics (AREA)
- Physics & Mathematics (AREA)
- Genetics & Genomics (AREA)
- Biochemistry (AREA)
- Microbiology (AREA)
- General Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Virology (AREA)
- Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Enzymes And Modification Thereof (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Abstract
Представлены композиции и способы, пригодные для определения того, присутствует ли микробный загрязнитель в процессе производства биологических терапевтических средств. Конкретно, представлены искусственная плазмида позитивного контроля амплификации и оригинальный зонд для количественной полимеразной цепной реакции (PCR), которые делают возможным быстрое детектирование и детектирование в реальном времени ложно позитивных результатов.
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201562139321P | 2015-03-27 | 2015-03-27 |
Publications (1)
Publication Number | Publication Date |
---|---|
EA202190319A1 true EA202190319A1 (ru) | 2021-09-30 |
Family
ID=56297073
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EA202190319A EA202190319A1 (ru) | 2015-03-27 | 2016-03-25 | Композиции и способы детектирования биологического загрязнителя |
EA201792155A EA037740B1 (ru) | 2015-03-27 | 2016-03-25 | Композиции и способы детектирования биологического загрязнителя |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EA201792155A EA037740B1 (ru) | 2015-03-27 | 2016-03-25 | Композиции и способы детектирования биологического загрязнителя |
Country Status (19)
Country | Link |
---|---|
US (3) | US10669594B2 (ru) |
EP (3) | EP3699298B1 (ru) |
JP (4) | JP6670847B2 (ru) |
KR (2) | KR102662675B1 (ru) |
CN (2) | CN114875175A (ru) |
AR (2) | AR104110A1 (ru) |
AU (2) | AU2016243498B2 (ru) |
CA (2) | CA2980915C (ru) |
DK (1) | DK3274469T3 (ru) |
EA (2) | EA202190319A1 (ru) |
ES (1) | ES2804845T3 (ru) |
IL (4) | IL302434A (ru) |
MX (2) | MX2017012437A (ru) |
PL (1) | PL3274469T3 (ru) |
PT (1) | PT3274469T (ru) |
SG (2) | SG11201707690QA (ru) |
TW (3) | TW202336236A (ru) |
WO (1) | WO2016160572A1 (ru) |
ZA (2) | ZA201706797B (ru) |
Families Citing this family (15)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
TW202336236A (zh) | 2015-03-27 | 2023-09-16 | 美商再生元醫藥公司 | 偵測生物污染物之組成物及方法 |
CA3066918A1 (en) | 2017-06-12 | 2018-12-20 | Bluefin Biomedicine, Inc. | Anti-il1rap antibodies and antibody drug conjugates |
US20190093149A1 (en) * | 2017-09-27 | 2019-03-28 | The United States Of America, As Represented By The Secretary Of Agriculture | Assays for detecting multiple tick-borne pathogens |
EP3746565A4 (en) * | 2018-01-30 | 2021-11-03 | BioFire Defense, LLC | METHODS AND SYSTEMS FOR VALIDATION OF A NUCLEIC ACID AMPLIFICATION ASSAY |
AU2019240057A1 (en) * | 2018-03-20 | 2020-10-08 | Lumacyte, LLC | Advanced biophysical and biochemical cellular monitoring and quantification using laser force cytology |
WO2019226648A1 (en) | 2018-05-21 | 2019-11-28 | Battelle Memorial Institute | Methods and control compositions for sequencing and chemical analyses |
EP3894553A4 (en) * | 2018-12-13 | 2022-06-29 | Battelle Memorial Institute | Methods and control compositions for a quantitative polymerase chain reaction |
KR102278112B1 (ko) * | 2020-07-10 | 2021-07-15 | (주)하임바이오텍 | 특정 인공 뉴클레오타이드 서열을 이용한 위양성 판단용 조성물 및 이를 이용한 위양성 판단 방법 |
KR102532614B1 (ko) * | 2020-09-18 | 2023-05-16 | 한국식품연구원 | 가공식품 및 농산물의 설치류 오염여부를 판별하는 방법 |
BR112023012014A2 (pt) * | 2020-12-17 | 2023-10-17 | Amgen Inc | Método de pcr em tempo real para detectar parvovírus bovino 3 |
KR102703684B1 (ko) * | 2021-07-13 | 2024-09-04 | 재단법인 바이오나노헬스가드연구단 | 미생물 현장 오염 검출용 조성물 및 이의 용도 |
CN114561492A (zh) * | 2022-02-28 | 2022-05-31 | 宁夏回族自治区疾病预防控制中心(宁夏回族自治区性病艾滋病防治中心) | 一种新冠病毒核酸检测阳性质控品及其制备方法和用途 |
WO2024137744A2 (en) * | 2022-12-23 | 2024-06-27 | Invisible Sentinel, Inc. | Methods for detecting alicyclobacillus contaminants |
CN116814848B (zh) * | 2023-04-12 | 2024-03-19 | 中国医学科学院医学实验动物研究所 | 基于荧光raa检测小鼠微小病毒的引物和探针及方法 |
CN118531166A (zh) * | 2024-07-26 | 2024-08-23 | 苏州药明检测检验有限责任公司 | 一种基于高通量测序技术的外源性病毒污染检测方法及其应用 |
Family Cites Families (24)
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US4683202A (en) | 1985-03-28 | 1987-07-28 | Cetus Corporation | Process for amplifying nucleic acid sequences |
US5585254A (en) * | 1987-08-21 | 1996-12-17 | University Of Colorado Foundation, Inc. | Autonomous parvovirus gene delivery vehicles and expression vectors |
US5371241A (en) | 1991-07-19 | 1994-12-06 | Pharmacia P-L Biochemicals Inc. | Fluorescein labelled phosphoramidites |
US7087411B2 (en) | 1999-06-08 | 2006-08-08 | Regeneron Pharmaceuticals, Inc. | Fusion protein capable of binding VEGF |
EP1077260B1 (en) | 1999-08-13 | 2010-03-31 | Deutsches Krebsforschungszentrum Stiftung des öffentlichen Rechts | Parvovirus NS1 variants |
AT409383B (de) | 1999-12-22 | 2002-07-25 | Baxter Ag | Verfahren zur detektion und quantifizierung von nukleinsäuren in einer probe |
AU2001283278A1 (en) * | 2000-08-10 | 2002-02-25 | Neurologix, Inc. | Replication competent aav helper functions |
CZ308201B6 (cs) * | 2001-06-28 | 2020-02-26 | Grifols Worldwide Operations Limited | Diagnostické zkoušky pro parvovirus B19 |
CN1302337C (zh) | 2002-03-08 | 2007-02-28 | Asml荷兰有限公司 | 光刻投射设备、所用的反射掩模以及器件制作方法 |
AU2003276634A1 (en) | 2002-11-12 | 2004-06-03 | Genolife | One step real-time rt pcr kits for the universal detection of organisms in industrial products |
JP4805158B2 (ja) * | 2003-05-16 | 2011-11-02 | アメリカ合衆国 | 核酸増幅系に用いる内部コントロール核酸分子 |
DE102006034844B3 (de) * | 2006-07-27 | 2007-12-06 | DRK-Blutspendedienst Baden-Württemberg-Hessen gGmbH | Zusammensetzungen und Verfahren zur Amplifikation von Hepatitis A-Viren (HAV) und/oder Parvoviren B19 (PB19) mittels Multiplex-PCR |
DK2150617T3 (en) | 2007-06-04 | 2015-01-12 | Regeneron Pharma | Regions with increased expression and stability |
EP2098599A1 (en) | 2008-03-05 | 2009-09-09 | Deutsches Krebsforschungszentrum, Stiftung des öffentlichen Rechts | Composition comprising an oligonucleotide mixture for the detection of contaminations in cell cultures |
US9834815B2 (en) * | 2009-03-25 | 2017-12-05 | Life Technologies Corporation | Discriminatory positive/extraction control DNA |
EP2445936A1 (en) | 2009-06-26 | 2012-05-02 | Regeneron Pharmaceuticals, Inc. | Readily isolated bispecific antibodies with native immunoglobulin format |
WO2012052158A2 (en) | 2010-10-21 | 2012-04-26 | Deutsches Krebsforschungszentrum | Retargeting of rat parvovirus h-1pv to cancer cells through genetic engineering of its capsid |
CA2828192A1 (en) * | 2011-02-25 | 2012-08-30 | Novartis Ag | Exogenous internal positive control |
CN102206713B (zh) * | 2011-04-06 | 2013-01-02 | 浙江大学 | 三重荧光定量rt-pcr检测试剂盒及用途 |
GB201203568D0 (en) * | 2012-02-29 | 2012-04-11 | Vela Operations Pte Ltd | Real time PCR detection of streptococcus |
HU230463B1 (hu) | 2012-07-02 | 2016-07-28 | Ud-Genomed Medical Genomic Technologies Kft. | Kontroll rendszer immunprecipitációs vizsgálatokhoz |
MX358755B (es) * | 2012-10-02 | 2018-09-03 | Proclara Biosciences Inc | Uso del p3 de proteinas de fusion de bacteriofago como agentes de union amiloides. |
GB2525024A (en) * | 2014-04-10 | 2015-10-14 | Vela Operations Pte Ltd | Universal controls for sequencing assays |
TW202336236A (zh) | 2015-03-27 | 2023-09-16 | 美商再生元醫藥公司 | 偵測生物污染物之組成物及方法 |
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2016
- 2016-03-24 TW TW112118669A patent/TW202336236A/zh unknown
- 2016-03-24 TW TW105109119A patent/TWI735433B/zh active
- 2016-03-24 TW TW110125474A patent/TWI804917B/zh active
- 2016-03-25 CN CN202210143904.4A patent/CN114875175A/zh active Pending
- 2016-03-25 JP JP2017550633A patent/JP6670847B2/ja active Active
- 2016-03-25 SG SG11201707690QA patent/SG11201707690QA/en unknown
- 2016-03-25 US US15/080,859 patent/US10669594B2/en active Active
- 2016-03-25 ES ES16734060T patent/ES2804845T3/es active Active
- 2016-03-25 IL IL302434A patent/IL302434A/en unknown
- 2016-03-25 EP EP20164343.4A patent/EP3699298B1/en active Active
- 2016-03-25 CA CA2980915A patent/CA2980915C/en active Active
- 2016-03-25 WO PCT/US2016/024216 patent/WO2016160572A1/en active Application Filing
- 2016-03-25 SG SG10202006108RA patent/SG10202006108RA/en unknown
- 2016-03-25 DK DK16734060.3T patent/DK3274469T3/da active
- 2016-03-25 KR KR1020177031064A patent/KR102662675B1/ko active IP Right Grant
- 2016-03-25 CA CA3226784A patent/CA3226784A1/en active Pending
- 2016-03-25 KR KR1020247014130A patent/KR20240063188A/ko active Search and Examination
- 2016-03-25 EP EP24161139.1A patent/EP4361290A3/en active Pending
- 2016-03-25 AU AU2016243498A patent/AU2016243498B2/en active Active
- 2016-03-25 EP EP16734060.3A patent/EP3274469B1/en active Active
- 2016-03-25 MX MX2017012437A patent/MX2017012437A/es unknown
- 2016-03-25 EA EA202190319A patent/EA202190319A1/ru unknown
- 2016-03-25 CN CN201680025470.0A patent/CN107960108B/zh active Active
- 2016-03-25 PL PL16734060T patent/PL3274469T3/pl unknown
- 2016-03-25 PT PT167340603T patent/PT3274469T/pt unknown
- 2016-03-25 EA EA201792155A patent/EA037740B1/ru unknown
- 2016-03-28 AR ARP160100814A patent/AR104110A1/es unknown
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2017
- 2017-09-27 MX MX2021007667A patent/MX2021007667A/es unknown
- 2017-09-27 IL IL254731A patent/IL254731B/en active IP Right Grant
- 2017-10-09 ZA ZA2017/06797A patent/ZA201706797B/en unknown
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2018
- 2018-09-12 ZA ZA2018/06101A patent/ZA201806101B/en unknown
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2020
- 2020-03-02 JP JP2020034913A patent/JP6894026B2/ja active Active
- 2020-04-22 US US16/855,217 patent/US11549154B2/en active Active
- 2020-09-01 AR ARP200102452A patent/AR119878A2/es unknown
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2021
- 2021-03-17 IL IL281579A patent/IL281579B/en unknown
- 2021-06-02 JP JP2021092874A patent/JP7385623B2/ja active Active
- 2021-12-28 IL IL289447A patent/IL289447A/en unknown
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2022
- 2022-10-05 AU AU2022246398A patent/AU2022246398A1/en active Pending
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2023
- 2023-05-04 US US18/061,712 patent/US20230295747A1/en active Pending
- 2023-11-10 JP JP2023191978A patent/JP2023184743A/ja active Pending
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