專業(yè)醫(yī)院lovo常用文件產品介紹customer presentation

1、 Copyright Fresenius Kabi AGJuly 26, 2022LOVO Cell Processing SystemIntroduction to LovoOverview of Spinning Membrane TechnologyProcedure OverviewReview of Laboratory DataProcessing Parameters and FeaturesKit ConfigurationData Management Copyright Fresenius Kabi AGJuly 26, 2022LOVO Cell Processing S

2、ystemAutomated Cell Processing for White Blood Cells:Supernatant or Culture Media ExchangeSupernatant Volume Reduction/ Cell ConcentrationReduction of PlateletsLovo is For Laboratory Use Only and does not have 510(k) clearanceEnables closed system processingLovo is the only cell processing system us

3、ing spinning membrane technology Copyright Fresenius Kabi AGJuly 26, 2022Fresenius Kabi considers the Lovo system for laboratory use and not subject to medical device registration, clearance, or approval by the U.S. Food and Drug Administration (FDA), European Union, Health Canada, or the Australian

4、 Therapeutics Goods Administration. Cells processed on this system that are intended for diagnostic purposes, for direct transfusion, or for use in the production of a therapeutic product(s) or vaccine(s) for clinical use may require advance regulatory clearance or approval, which is the sole respon

5、sibility of the user.LOVO Cell Processing SystemIntroduction to LovoOverview of Spinning Membrane TechnologyProcedure OverviewReview of Laboratory DataProcessing Parameters and FeaturesKit ConfigurationData Management Copyright Fresenius Kabi AGJuly 26, 2022What is Spinning Membrane Filtration?Spinn

6、ing Membrane Technology is used in lieu of a centrifuge to separate supernatant from cellular componentsThe module is single-use and part of the disposable set Copyright Fresenius Kabi AGJuly 26, 2022Cell sourceinput portSupernatantoutput portSupernatantchannelsSpinning Membrane ModuleSpinning Membr

7、ane Module is comprised of three components Copyright Fresenius Kabi AGJuly 26, 2022Rotating Inner RotorFiltration MembraneStationary Cylindrical HousingPolycarbonate Membrane Filtration Utilizes Cell Size DiscriminationFenwal Overview Presentation | 7/26/20227Polycarbonate Membrane4.0 m pore size10

8、 m thicknessEtched, cylindrical poreRetains WBCs and some RBCsApproximate Scale:= RBC= WBC=PLTSEM of Polycarbonate MembraneSpinning Membrane Technology Overview Copyright Fresenius Kabi AGJuly 26, 2022Why Spinning Membrane Technology?Small Volume in the Spinner12 mL capacity Easy Fluid ManagementNo

9、spin-up or down of a centrifugeAble to re-direct cells quicklyNon-Pelletizing to CellsManual re-suspension of cells not necessary Copyright Fresenius Kabi AGJuly 26, 2022SimpleFastQuietLOVO Cell Processing SystemIntroduction to LovoOverview of Spinning Membrane TechnologyProcedure OverviewReview of

10、Laboratory DataProcessing Parameters and FeaturesKit ConfigurationData Management Copyright Fresenius Kabi AGJuly 26, 2022Procedure overviewA typical Lovo procedure consists of a series of wash cycles (number configurable by the operator)Each cycle consists of: Concentration PhaseConcentration ratio

11、s would be modified depending on the type of source and can range from 40:1 to 2:1 (e.g. 10:1 for fresh T-cells, 2:1 for cryopreserved cells)Dilution PhaseFollowing concentration, target cells will be diluted to the original source volume or maximum volume of the in-process container Copyright Frese

12、nius Kabi USAJuly 26, 2022Supernatant Concentration100%Supernatant Volume100 mLWash Media Volume0 mLCell Concentration1xNumber of Cells50Overview of a 2-Wash Cycle Process10:1 Concentration10:1 Concentration1:10 Dilution10:1 Concentration1:10 DilutionSupernatant Concentration10%Supernatant Volume90

13、mLCell Concentration1xNumber of Cells50100%10 mL0 mL10 x5010%90 mL1x501%9 mL10 x501%99 mL1x5012Procedure Start: 500 mL Source Product Copyright Fresenius Kabi AGJuly 26, 2022500 mL SourceProductWash MediaFiltrateWash Cycle: Concentration Phase Copyright Fresenius Kabi AGJuly 26, 202250 mL In-process

14、(Concentrated)FiltrateWash Cycle: Dilution Phase Copyright Fresenius Kabi AGJuly 26, 2022500 mL In-process(Diluted)Wash MediaFiltrateUser-Defined Final Target Product Volume Copyright Fresenius Kabi AGJuly 26, 2022User-definedProduct VolumeFiltrateTheoretical Percent Washout Based upon Concentration

15、 Ratio Copyright Fresenius Kabi AGJuly 26, 2022Number of Wash CyclesConcentration Ratio1*2345610:190%99%99.9%99.99%99.999%99.9999%5:180%96%99.6%99.96%99.996%99.9996%2:150%75%99.5%99.95%99.995%99.9995%Most commonly used washout targets*Lovo is not able to perform a 1-cycle wash. Washout targets for 1

16、-cycle are included for illustrative purposes only.LOVO Cell Processing SystemIntroduction to LovoOverview of Spinning Membrane TechnologyProcedure OverviewReview of Laboratory DataProcessing Parameters and FeaturesKit ConfigurationData Management Copyright Fresenius Kabi AGJuly 26, 2022Lovo Prototy

17、pe Instrument: High supernatant removal with good TNC recovery1 Copyright Fresenius Kabi AGJuly 26, 2022Post-Wash RecoveriesFresh PBMC Products92% TNC Recovery86% Platelet Removal25% RBC Removal99% Supernatant Removal7 min (200 mL to 150 mL) (processing only)Additional Post-Processing Detail1Present

18、ed at the 19th Annual International Society for Cell Therapies Meeting, April 2013. Data collected using prototype instrument. Wegener C, Heber C, Min K (2013). Novel Cell Washing Device Using Spinning Membrane Filtration. Cytotherapy. 15(4) S27. Abstract 86.Post-wash cell recoveries from a 2 wash c

19、ycle protocol using 10:1 concentration ratio. Recoveries are shown as percent of source cell suspension recovered in washed product.Lovo Prototype Instrument: Viabilities between washed and unwashed cells not different1 Copyright Fresenius Kabi AGJuly 26, 20221Presented at the 19th Annual Internatio

20、nal Society for Cell Therapies Meeting, April 2013. Data collected using prototype instrument. Wegener C, Heber C, Min K (2013). Novel Cell Washing Device Using Spinning Membrane Filtration. Cytotherapy. 15(4) S27. Abstract 86.3-Day Lymphocyte Apoptosis Levels(n=5)Day-3 Lymphocyte Proliferation(n=4)

21、LOVO Cell Processing SystemIntroduction to LovoOverview of Spinning Membrane TechnologyProcedure OverviewReview of Laboratory DataProcessing Parameters and FeaturesKit ConfigurationData Management Copyright Fresenius Kabi AGJuly 26, 2022Key Processing Parameters*ParameterLower LimitUpper LimitInput

22、Source Volume Range (mL)On-Scale ProcessingOff-Scale Processing100*100*2500 7000Final Product Volume Range (mL)On-Scale ProcessingOff-Scale Processing505025005000Supernatant Washout Range75%99.9999%Source Packed Cell Volume (PCV) %.1100Number of Wash Cycles26Processing Speed (mL/min)5200 Copyright F

23、resenius Kabi AGJuly 26, 2022* Lower source volume may meet lower limit requirements by increasing source volume with wash media Note: Ranges vary based upon cell type, concentration and source volumeLovo provides additional processing flexibility through admin settings Copyright Fresenius Kabi AGJu

24、ly 26, 2022ParameterDefaultLower LimitUpper LimitBenefitConcentration RatioInlet Flow Rate : Outlet (RET) Flow RateInlet Flow Rate (mL/min)Outlet (RET) Flow Rate (mL/Min)10:1150152:15540:1200200Modify concentration ratio for different cell types and/or cell concentrationsDesired Inlet PCV%3110Balanc

25、e time & final target volumeIdle Spinner Revolution Rate (rpm)60005500Increase or decrease mixing during rinseProcessing Spinner Revolution Rate(rpm)300005500Increase or decrease mean size of cells retainedFinal Product Media Suspension Rate (mL/min)1505200Rate at which you volume up to final target

26、 volumeSource Rinse Volume(mL)200759Increase/decrease to balance cell retention with final product volumeSource Prime Volume(mL)337900Method to add volume to source; rate not configurablePump Speeds Combined with Fluid Management Results in Fast Processing Cell TypeApproximate Source VolumeFinal Tar

27、get VolumeWashout TargetProcessing TimeFresh PBMCs200 mL150 mL 99%7 minsCryopreserved PBMCs240 mL150 mL99%15 mins CD4+ T-Cells2000 mL150 mL99%30 minsJurkat Cells1200 mL100 mL99%25 mins Copyright Fresenius Kabi AGJuly 26, 2022Sample Processing Times* Data are intended to be directional only. Multiple

28、 variables including cell concentration can effect processing times. Data on File.Lovo System FeaturesTwo key features improve cell processing and simplify ease of use:Intelligent AutoDilutionProduct Estimator Copyright Fresenius Kabi AGJuly 26, 2022Understanding Packed Cell VolumePacked Cell Volume

29、 percent (PCV%) is the portion of volume occupied by cellsPCV is an important Lovo processing parameter for both the cell source and the spinning membrane Copyright Fresenius Kabi AGJuly 26, 2022PCV Calculator for LovoLovo System Features:Intelligent AutoDilutionAutoDilution feature automatically di

30、lutes source products with high cell concentrationsAlways active unless an operator selects No DilutionSource PCV range is 1-100%Desired Inlet PCV range is 1% to 10%For example, if the Source PCV is 12% and the Desired PCV is 3%, Lovo will dilute the source product to 3% for processing Copyright Fre

31、senius Kabi AGJuly 26, 2022Lovo System Features:Product EstimatorProvides estimates for Operator to facilitate processing:Processing TimeSupernatant washout %Volume of wash media neededVolume of filtrate produced Copyright Fresenius Kabi AGJuly 26, 2022Using Inlet PCV and Concentration Ratio to Opti

32、mize Lovo Processing Copyright Fresenius Kabi AGJuly 26, 2022Operator can use Concentration Ratio and Desired Inlet PCV to balance other processing goalsExample shown: source volume: 250 mL, source PCV: 15%, target volume: 200 mLLOVO Cell Processing SystemIntroduction to LovoOverview of Spinning Mem

33、brane TechnologyProcedure OverviewReview of Laboratory DataProcessing Parameters and FeaturesKit ConfigurationData Management Copyright Fresenius Kabi AGJuly 26, 2022Lovo Single-Use Processing KitProcessing Kit enables closed system processingTwo tubing leads for washing and/or media solutions2.5 L

34、Filtrate (waste) Container800 mL Retentate (final product) Container800 mL In-Process ContainerSampling ports on the final product (spike and luer) and waste containers (injection port and luer)Spinning membrane module with 4 polycarbonate membrane Copyright Fresenius Kabi AGJuly 26, 2022X6R4901LOVO Cell Processing SystemIntroduction to LovoOverview of Spinning Membrane TechnologyProcedure OverviewReview of Laboratory DataProcessing Parameters and FeaturesKit ConfigurationData Management Copyright Fresenius Kabi AGJuly 26, 2022Data Ma