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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” 【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),無需再懸浮 離散處理(業(yè)界獨(dú)家)自動“多高速加濾過技術(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,自動化,大幅減少人工干預(yù),無需人工看管(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)品分類國際又名“硬分離清洗技術(shù) ”國際又名“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、動轉(zhuǎn)子濾過法清除基質(zhì)液體,而非離心分離法,因而沒有細(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”技術(shù) 帶來的獨(dú)特優(yōu)勢Improve mouclear cell recovery單個核細(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無離心技術(shù)造成的細(xì)胞eed Cell Resuspen無需細(xì)胞離散在懸浮處理效應(yīng)Speed ! Automated !高效,全自動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),無需再懸浮處理Lovo 多Lovo全自動,無需人工干預(yù),避免看管技術(shù)加濾過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),無需再懸浮處理Lovo 多加濾過技術(shù)17Lovo全自動,無需人工干預(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”技術(shù) 細(xì)胞保護(hù)的獨(dú)特優(yōu)勢細(xì)胞損傷小細(xì)胞回收率高細(xì)胞活性保持佳無細(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、 多加濾過技術(shù)22Lovo全自動,無需人工干預(yù),避免看管Lovo細(xì)胞保持懸浮狀態(tài),無需再懸浮處理Automate with LOVO旋轉(zhuǎn)濾過膜技術(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),無需再懸浮處理Lovo 多加濾過技術(shù) 25Lovo全自動,無需人工干預(yù),避免看管Automate with LOVOLovo 多加濾過技術(shù)純度的產(chǎn)品 獲得指數(shù)級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),無需再懸浮處理Lovo 多加

22、濾過技術(shù)Lovo全自動,無需人工干預(yù),避免看管29Automate with LOVO技術(shù)原理決定使用便捷便利操作,無需過多人工看管操作安裝管路,設(shè)定好幾項(xiàng)簡單參數(shù)后,無需人工看管!液晶觸摸控制屏全自動化處理管路安裝極簡 Copyright Fresenius Kabi AGJune 9, 2017NOVEL CELL WASHING DEVICE USINGSPINNINGMEMBRANE FILTRATION獨(dú)家“旋轉(zhuǎn)膜濾過”技術(shù) 帶來的獨(dú)特優(yōu)勢Improve mouclear cell recovery單個核細(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無離心技術(shù)造成的細(xì)胞eed Cell Resuspen無需細(xì)胞離散在懸浮處理效應(yīng)Speed ! Automated !高效,全自動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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