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1、 Copyright Fresenius Kabi AGJune 9, 2017FORTUNE GLOBAL 500 !Fresenius Kabi Deutschland GmbHBad Homburg v. d. H., GermanyCOM.TECVersatile Multi-Procedural Apheresis PlatformLovo 在 多種細(xì)胞處理技術(shù),多環(huán)節(jié)廣泛應(yīng)用Lovo用途自動(dòng)化細(xì)胞高效去除培養(yǎng)液,上清液,藥物,雜質(zhì),血小板等保存液,液替換/置換細(xì)胞濃縮,產(chǎn)品體積壓縮純化用于科研,生物制品生產(chǎn)加工,制藥,生物技術(shù)等廣泛領(lǐng)域在多環(huán)節(jié),廣泛使用Lovo特性業(yè)界獨(dú)家使用“旋

2、轉(zhuǎn)膜濾過(guò)” 【Spinning Membrane Filtration】 ,非離心式提取原理(業(yè)界獨(dú)家)溫和處理技術(shù),減少細(xì)胞損傷,不但沒(méi)有高速離心造成的細(xì)胞損傷,“微旋流”保護(hù)細(xì)胞(業(yè)界獨(dú)家)細(xì)胞始終“始終保持懸浮”狀態(tài),無(wú)需再懸浮 離散處理(業(yè)界獨(dú)家)自動(dòng)“多高速加濾過(guò)技術(shù)”,首次90%純度產(chǎn)品,2次99%,3次99.9%,4次99.99%. (業(yè)界獨(dú)家)分離,高效,快速,自動(dòng)化,大幅減少人工干預(yù),無(wú)需人工看管(業(yè)界最優(yōu))Lovo在多種細(xì)胞處理技術(shù),多環(huán)節(jié)廣泛應(yīng)用T-Cell with CARCAR-T帶有特異性腫瘤識(shí)別功能的T淋巴細(xì)胞添加 CARCAR(chimeric antigen

3、receptor)嵌合抗原受體一種能夠識(shí)別特異性腫瘤抗原的特殊受體COM.TECMouclear CellVersatile Multi-Procedural Apheresis Platform細(xì)胞產(chǎn)品洗滌純化產(chǎn)品分類(lèi)國(guó)際又名“硬分離清洗技術(shù) ”國(guó)際又名“軟分離清洗技術(shù) ”6COM.TECVersatile Multi-Procedural Apheresis PlatformFresenius Cell Washing Concept旋轉(zhuǎn)式濾膜系統(tǒng)用于分離細(xì)胞及基質(zhì)液體,雜質(zhì),學(xué)校板等 Spinning membrane technology used inplasmapheresis磁驅(qū)

4、動(dòng)轉(zhuǎn)子濾過(guò)法清除基質(zhì)液體,而非離心分離法,因而沒(méi)有細(xì)胞凝聚效應(yīng) Remove supernatant by filtration; no初產(chǎn)品pelletization膜式分離按照分子大小區(qū)隔,去除所有小于4um 細(xì)胞基質(zhì)液及雜質(zhì) Membra“size discrimination”; exlection allows forle:Generally, retain cell content 4um; Remove cellcontent 4um后濃縮細(xì)胞出口連續(xù)式處理技術(shù),沒(méi)有容量大小限制 Automatedpros without volume limiionsFenwal Overvi

5、ew Presen ion | 6/9/20177洗滌廢液出口Polycarbonate Membrane Filtration Utilizes Cell Size DiscriminationPolycarbonate Membrane4.0 m pore size10 m thicknessEtched, cylindrical poreRetains WBCs and someRBCsApproximate Scale:SEM of Polycarbonate Membrane= RBC= WBC=PLTFenwal Overview Presen ion | 6/9/20178NOV

6、EL CELL WASHING DEVICE USINGSPINNINGMEMBRANE FILTRATION獨(dú)家“旋轉(zhuǎn)膜濾過(guò)”技術(shù) 帶來(lái)的獨(dú)特優(yōu)勢(shì)Improve mouclear cell recovery單個(gè)核細(xì)胞恢復(fù)率Minimizing Cell loss大大降低細(xì)胞損傷丟失Avoid cell damage caused by high-speed centrifugation完全杜絕離心技術(shù)導(dǎo)致的細(xì)胞損傷-Pelletizing to Cells無(wú)離心技術(shù)造成的細(xì)胞eed Cell Resuspen無(wú)需細(xì)胞離散在懸浮處理效應(yīng)Speed ! Automated !高效,全自動(dòng)Lovo

7、 is the only cell prosing system usingspinning membrane technology !June 9, 2017 Copyright Fresenius Kabi AGKey Profile of Lovo10Lovo 連續(xù)式處理技術(shù),高效,不受液體量限制 Lovo 細(xì)胞損傷小,細(xì)胞恢復(fù)率高 Lovo細(xì)胞保持懸浮狀態(tài),無(wú)需再懸浮處理Lovo 多Lovo全自動(dòng),無(wú)需人工干預(yù),避免看管技術(shù)加濾過(guò)Automate with LOVOSee!Lovo 連續(xù)式處理技術(shù),高效,不受液體量限制 Copyright Fresenius Kabi AGJune 9

8、, 2017Procedure Start:500 mL Source Product500 mL Source Product Copyright Fresenius Kabi AGJune 9, 2017FiltrateWash MediaWash Cycle: Concentration Phase50 mL In-pro (Concentrated)s Copyright Fresenius Kabi AGJune 9, 2017FiltrateWash Cycle: Dilution Phase500 mL In-pro(Diluted)s Copyright Fresenius K

9、abi AGJune 9, 2017FiltrateWash MediaUser-Defined FinalProduct VolumeUser-defined Product Volume Copyright Fresenius Kabi AGJune 9, 2017FiltratePump Speeds Combined with Fluid Management Results in Fast ProsingSle Prosing Times*Approximate Source VolumeFinalVolumeWashoutProsingCell TypeTimeFresh PBMC

10、s200 mL150 mL99%7 minsCryop240 mL150 mL99%15 minsPBMCsCD4+ T-Cells2000 mL150 mL99%30 minsJurkat Cells1200 mL100 mL99%25 mins* Data areended to be directional only. Multiplevariables includingcellconcentration can effect prosing times. Data on File. Copyright Fresenius Kabi AGJune 9, 2017Key Profile

11、of LovoLovo 連續(xù)式處理技術(shù),高效,不受液體量限制Lovo細(xì)胞保持懸浮狀態(tài),無(wú)需再懸浮處理Lovo 多加濾過(guò)技術(shù)17Lovo全自動(dòng),無(wú)需人工干預(yù),避免看管Lovo 細(xì)胞損傷小,細(xì)胞恢復(fù)率高Automate with LOVO獨(dú)家“旋轉(zhuǎn)膜濾過(guò)”技術(shù) 細(xì)胞保護(hù)的獨(dú)特優(yōu)勢(shì)細(xì)胞損傷小細(xì)胞回收率高細(xì)胞活性保持佳無(wú)細(xì)胞,反而更充分懸浮離散WBCRBCPLTD ev i c e W a l lM em b r a n e F i l t er LOVO 細(xì)胞保護(hù)之 MNC 恢復(fù)率 Data Presenion at ISCT Copyright Fresenius Kabi AGWashed Pr

12、oduct % RecoverySpinning Membranet-Wash MNCRecovery (n=22)100%90%80%70%WBC60%RBC50%40%PLT30%Sup20%10%0%Lovo Prototype Instrument:High supernatant removal with good TNC recovery1t-Wash RecoveriesAdditionalt-Prosing Detail100%Fresh PBMC Products92% TNC Recovery92.3%80%74.4%86% Plaet Removal60%25% RBC

13、Removal99% Supernatant Removal7 min (200 mL to 150 mL)40%20%14.2%(prosing only)1.3%0%TNCRBCPlaetpernatantt-wash cell recoveries from a 2 wash cycle protocol using 10:1 concentrationratio. Recoveries are shown as percent of source cell suspenwashed product.recovered in1Presented at the 19nnualernatio

14、nal Society for Cell Therapies Meeting, April 2013. Dollected using prototype instrument.Wegener C, Heber C, Min K (2013). Novel Cell Washing Device Using Spinning Membrane Filtration. Cytotherapy. 15(4) S27. Abstract 86. Copyright Fresenius Kabi AGJune 9, 2017Lovo Prototype Instrument:Viabilities b

15、etn washed and unwashed cells not different13-Day Lymphocyte Apoptosis Levels(n=5)Day-3 Lymphocyte Proliferation(n=4)908070605040302010014.0012.0010.008.006.004.002.000.000123DayUnwashedWashedUnwashedWashed1Presented at the 19nnualernational Society for Cell Therapies Meeting, April 2013. Dollected

16、using prototype instrument.Wegener C, Heber C, Min K (2013). Novel Cell Washing Device Using Spinning Membrane Filtration. Cytotherapy. 15(4) S27. Abstract 86. Copyright Fresenius Kabi AGJune 9, 2017% Annexin V+% Lymphocyte ProliferationKey Profile of LovoLovo 連續(xù)式處理技術(shù),高效,不受液體量限制Lovo 細(xì)胞損傷小,細(xì)胞恢復(fù)率高Lovo

17、 多加濾過(guò)技術(shù)22Lovo全自動(dòng),無(wú)需人工干預(yù),避免看管Lovo細(xì)胞保持懸浮狀態(tài),無(wú)需再懸浮處理Automate with LOVO旋轉(zhuǎn)濾過(guò)膜技術(shù)細(xì)胞保持“懸浮離散狀態(tài)”,并在“微旋流”中受到保護(hù)旋轉(zhuǎn)技術(shù)轉(zhuǎn)膜外側(cè)產(chǎn)生“微旋流”,雜質(zhì)在外被“吸除”,而“白細(xì)胞/單個(gè)核細(xì)胞”在最內(nèi)側(cè)包繞而“受到保護(hù)”,并一直處于離散懸浮狀態(tài)Typical Cell Wash傳統(tǒng)離心式細(xì)胞純化方式 細(xì)胞經(jīng)過(guò)離心壓縮,還需再懸浮處理!傳統(tǒng)離心式細(xì)胞純化方式而Lovo完全不需要!Pelletize細(xì)胞離心壓縮Decant棄除分離液Manual prosRequires centrifugationNot conveni

18、ent for large volumesResuspend再離散懸浮Fenwal Overview Presen ion | 6/9/201724Key Profile of LovoLovo 連續(xù)式處理技術(shù),高效,不受液體量限制Lovo 細(xì)胞損傷小,細(xì)胞恢復(fù)率高Lovo細(xì)胞保持懸浮狀態(tài),無(wú)需再懸浮處理Lovo 多加濾過(guò)技術(shù) 25Lovo全自動(dòng),無(wú)需人工干預(yù),避免看管Automate with LOVOLovo 多加濾過(guò)技術(shù)純度的產(chǎn)品 獲得指數(shù)級(jí)Overview of a 2-Wash Cycle Pros10:1Concentration1:10Dilution1Supernatant C

19、oncentration Supernatant Volume Wash Media Volume Cell ConcentrationNumber of Cells100%100 mL0 mL 1x 50100%10 mL0 mL 10 x 5010%90 mL1x 5010:1Concentration1:10Dilution2Supernatant Concentration Supernatant Volume Wash Media Volume Cell ConcentrationNumber of Cells10%90 mL1x 501%9 mL10 x 501%99 mL1x 5

20、010:1 Concentration特有“多加濾過(guò)技術(shù)” 首次90%清除,2次99%,3次99.9%,4次99.99%.Number of Wash Cycles99% supernatant reduction! in under 7 minutes! in a 200 mL source product“多加濾過(guò)技術(shù)”為Fresenius Lovo 特有傳統(tǒng)的離心濃縮技術(shù),由于離心力造成細(xì)胞損傷,無(wú)法多重處理.*Lovo is not able to perform a 1-cycle wash. Washouts for 1-cycle are included for illustr

21、ative pures only. Copyright Fresenius Kabi AGJune 9, 2017Most commonly usedwashoutsConcentration1*23456Ratio10:190%99%99.99%99.999%99.9999%99.9%5:180%96%99.6%99.96%99.996%99.9996%2:150%75%99.5%99.95%99.995%99.9995%Key Profile of LovoLovo 連續(xù)式處理技術(shù),高效,不受液體量限制Lovo 細(xì)胞損傷小,細(xì)胞恢復(fù)率高Lovo細(xì)胞保持懸浮狀態(tài),無(wú)需再懸浮處理Lovo 多加

22、濾過(guò)技術(shù)Lovo全自動(dòng),無(wú)需人工干預(yù),避免看管29Automate with LOVO技術(shù)原理決定使用便捷便利操作,無(wú)需過(guò)多人工看管操作安裝管路,設(shè)定好幾項(xiàng)簡(jiǎn)單參數(shù)后,無(wú)需人工看管!液晶觸摸控制屏全自動(dòng)化處理管路安裝極簡(jiǎn) Copyright Fresenius Kabi AGJune 9, 2017NOVEL CELL WASHING DEVICE USINGSPINNINGMEMBRANE FILTRATION獨(dú)家“旋轉(zhuǎn)膜濾過(guò)”技術(shù) 帶來(lái)的獨(dú)特優(yōu)勢(shì)Improve mouclear cell recovery單個(gè)核細(xì)胞恢復(fù)率Minimizing Cell loss大大降低細(xì)胞損傷丟失Avoid

23、 cell damage caused by high-speed centrifugation完全杜絕離心技術(shù)導(dǎo)致的細(xì)胞損傷-Pelletizing to Cells無(wú)離心技術(shù)造成的細(xì)胞eed Cell Resuspen無(wú)需細(xì)胞離散在懸浮處理效應(yīng)Speed ! Automated !高效,全自動(dòng)Lovo is the only cell prosing system usingspinning membrane technology !June 9, 2017 Copyright Fresenius Kabi AGLOVO Cell Prosing SystemAutomated Cell ProWhite Blood Cells:sing forSupernatant or Culture MediaExchangeSupernatant Volume Reduction/ CellConcentrationReduction of PlaetsLovo is For Laboratory Use Onlyand does nove 510(k) clearanceEnables closed system prosingLovo is

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