DK3124976T3 - Forbedret bakteriel endotoxintest til bestemmelsen af endotoxiner - Google Patents
Forbedret bakteriel endotoxintest til bestemmelsen af endotoxiner Download PDFInfo
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- DK3124976T3 DK3124976T3 DK15178683.7T DK15178683T DK3124976T3 DK 3124976 T3 DK3124976 T3 DK 3124976T3 DK 15178683 T DK15178683 T DK 15178683T DK 3124976 T3 DK3124976 T3 DK 3124976T3
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- Prior art keywords
- sample
- endotoxin
- rituximab
- antibody
- dialysis
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Classifications
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- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/569—Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
- G01N33/56911—Bacteria
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- G—PHYSICS
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- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/579—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving limulus lysate
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
- G01N1/38—Diluting, dispersing or mixing samples
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- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
- G01N33/6854—Immunoglobulins
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- G—PHYSICS
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- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
- G01N2333/195—Assays involving biological materials from specific organisms or of a specific nature from bacteria
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- G—PHYSICS
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- G01N2400/00—Assays, e.g. immunoassays or enzyme assays, involving carbohydrates
- G01N2400/10—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- G01N2400/50—Lipopolysaccharides; LPS
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
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- Peptides Or Proteins (AREA)
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Claims (17)
1. Fremgangsmåde til fremstillingen af en prøve til et limulus amoebocyte lysate (LAL) assay, hvor prøven omfatter et antistof, og hvor fremgangsmåden omfatter følgende trin i den følgende orden: (a) tilsætte magnesiumioner, fortrinsvis i form af MgCL·, til prøven, (b) fortynde prøven, og (c) dialysere prøven med en pH-værdi på 5,7-8,0 mod en endotoxin-fri vandig opløsning.
2. Fremgangsmåde til bestemmelse af bakteriel endotoxin i en prøve omfattende et antistof der udviser LER-effekt, hvor fremgangsmåden omfatter følgende trin i den følgende orden: (a) tilsætte magnesiumioner, fortrinsvis i form af MgCL·, til prøven, (b) fortynde prøven, (c) dialysere prøven med en pH-værdi på 5,7-8,0 mod en endotoxin-fri vandig opløsning, og (d) bestemme bakteriel endotoxin i prøven under anvendelse af et LAL-assay.
3. Fremgangsmåde ifølge krav 1 eller 2, hvor antistoffet er et terapeutisk antistof.
4. Fremgangsmåde ifølge et hvilket som helst af kravene 1-3, hvor antistoffet er formuleret med polysorbat 80.
5. Fremgangsmåde ifølge et hvilket som helst af kravene 1-4, hvor antistoffet er formuleret med en citratbuffer.
6. Fremgangsmåde ifølge et hvilket som helst af kravene 1-5, hvor antistoffet er formuleret med en ca. 25 mM natriumcitratbuffer og ca. 700 mg/l polysorbat 80 og har en pH-værdi på ca. 6,5.
7. Fremgangsmåde ifølge et hvilket som helst af kravene 1-6, hvor antistoffet er anti-CD20-antistoffet rituximab.
8. Fremgangsmåde ifølge et hvilket som helst af kravene 1-7, hvor i trin (a) magnesiumioner tilsættes til en slutkoncentration på ca. 25 til 75 mM.
9. Fremgangsmåde ifølge et hvilket som helst af kravene 1-8, hvor i trin (b) pH-værdien af prøven justeres ved at fortynde prøven med 10-50 mM Tris/HCI buffer pH 6,0-9,0, fortrinsvis 6,0-8,0.
10. Fremgangsmåde ifølge et hvilket som helst af kravene 1-9, hvor i trin (b) prøven fortyndes ved et forhold på 1:10.
11. Fremgangsmåde ifølge et hvilket som helst af kravene 1-10, hvor under dialyse i trin (c) prøven har en pH-værdi på 6,0-8,0.
12. Fremgangsmåde ifølge et hvilket som helst af kravene 1-11, hvor i trin (c) dialysen varer ca. 24 timer ved stuetemperatur.
13. Fremgangsmåde ifølge et hvilket som helst af kravene 1-12, hvor til dialysen i trin (c) anvendes en membran med en molekylevægt cut-off på 10 kDa.
14. Fremgangsmåde ifølge et hvilket som helst af kravene 1-13, hvor til dialysen i trin (c) anvendes en celluloseacetatmembran.
15. Fremgangsmåde ifølge et hvilket som helst af kravene 1-14, hvor til dialysen i trin (c) skiftes vandet to gange.
16. Fremgangsmåde ifølge et hvilket som helst af kravene 2-15, yderligere omfattende at fremstille en lav-endotoxingenvinding (LER) positiv kontrol ved spiking af en kendt mængde endotoxin til en alikvot af prøven og ryste den endotoxin-spikede alikvot af prøven i 60 min til 2 timer.
17. Anvendelse af fremgangsmåden ifølge et hvilket som helst af kravene 1-16 for at gøre prøven omfattende et antistof reaktiv mod faktor C i den LAL-enzymatiske kaskade.
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| EP15178683.7A EP3124976B1 (en) | 2015-07-28 | 2015-07-28 | Improved bacterial endotoxin test for the determination of endotoxins |
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| US11099189B2 (en) | 2017-10-17 | 2021-08-24 | Board Of Regents, The University Of Texas System | Limulus amoebocyte lysate assay and method of same |
| EP3483609B1 (en) * | 2017-11-09 | 2022-01-05 | Andreas Buchberger | Method and kit for sample preparation and endotoxin determination |
| CN109613228A (zh) * | 2018-12-20 | 2019-04-12 | 湛江安度斯生物有限公司 | 一种减少或消除氢氧化铝佐剂干扰细菌内毒素检测的方法 |
| CN111141909B (zh) * | 2019-12-24 | 2023-05-30 | 南京健友生化制药股份有限公司 | 一种凝胶法检测硫代甘油中细菌内毒素的方法 |
| US11965888B2 (en) * | 2020-04-09 | 2024-04-23 | DePuy Synthes Products, Inc. | Quantifying endotoxin load in bacterial biofilms |
| CN112462015B (zh) * | 2020-11-18 | 2022-07-12 | 海南倍特药业有限公司 | 一种氢溴酸瑞马唑仑细菌内毒素的检测方法 |
| CN116242977A (zh) * | 2022-12-14 | 2023-06-09 | 无锡药明生物技术股份有限公司 | 内毒素保留时间的估算方法及其应用 |
| CN116609521B (zh) * | 2023-01-17 | 2025-12-02 | 河北省药品医疗器械检验研究院(河北省化妆品检验研究中心) | 重组乙型肝炎疫苗细菌内毒素快速检测试剂盒及其使用方法 |
| CN116396916B (zh) * | 2023-03-02 | 2023-12-01 | 广州普言生物科技有限公司 | 低内毒素大肠杆菌及低内毒素重组人源胶原蛋白大肠杆菌工程菌 |
| CN117969228B (zh) * | 2024-04-02 | 2024-05-28 | 成都翼泰生物科技有限公司 | 一种菌液稀释液、制备方法、参考品、试剂盒及其应用 |
| CN120594816B (zh) * | 2025-06-20 | 2025-11-25 | 北京全式金生物技术股份有限公司 | 一种重组c因子法检测内毒素的反应缓冲液及其应用 |
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| US2123198A (en) * | 1936-10-23 | 1938-07-12 | Lederle Lab Inc | Treatment of antitoxins and the like |
| US4096091A (en) * | 1974-07-17 | 1978-06-20 | Baxter Travenol Laboratories, Inc. | Limulus lysate having improved capacity to precipitate in the presence of low endotoxin concentrations, and reconstituting solutions therefor |
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| EP0107688B1 (en) * | 1982-04-28 | 1986-10-01 | The Trustees Of The Garfield Weston Trust For Research Into Heart Surgery | Processes for the production of blood products |
| US4816567A (en) | 1983-04-08 | 1989-03-28 | Genentech, Inc. | Recombinant immunoglobin preparations |
| DK255887D0 (da) * | 1987-05-20 | 1987-05-20 | Claus Koch | Immunoassay |
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