專業(yè)醫(yī)院lovo常用文件產(chǎn)品介紹4

1、 Copyright Fresenius Kabi AGLOVO Product OverviewLOVO Cell Washing InstrumentLovo is a cell washing/processing device designed to meet the expanding needs of researchers, contract manufacturers, pharmaceutical and biotech organizations who are seeking a simple and automated method of separating cell

2、s and supernatant. Lovo is a laboratory instrument not requiring FDA 510(k) clearance, but will require CE marking for entrance into European markets Copyright Fresenius Kabi AGLaunch QuarterLaunch MarketsMTPKey FeaturesCER (US only) February 2014Full Launch (CE mark) June 2014CER targets are USFull

3、 launch targets include all RegionsAnticipated MTPs Device 18kDisposables 35 Highly efficient WBC washing3 pumps, 4 scales, 7 clamps for flexibilityCellular Therapies Work-Flow(s) Copyright Fresenius Kabi USAApheresisBone Marrow (BM)Umbilical Cord Blood (UCB)Adipose Derived(ASC)Collection. . .Upstre

4、am ProcessingSelectionMagneticAdherentDensityWashFreezingCulture/Expansion2D CultureStirred CellBag CultureManipulationCytokinesAntigensElectroporesisDownstream ProcessingWashFreezingSaftey ChecksSterilityPotencyIdentityVolume ReductionInfusionCell ProductPlacentalEmbryonic Stem Cells (ESC)LOVO Wash

5、es Cells by Removing Supernatant & Diluting Cells410:1 Concentration1:10 Dilution10%100%Batch Washing System 1-Log Reduction for every pass of the membrane300 mLSupernatant30 mL Supernatant30 mL Supernatant (original)270mL Wash30 mL Supernatant (original)270mL Wash Copyright Fresenius Kabi AGLOVO Wa

6、shes Cells by Removing Supernatant & Diluting Cells10:1 Concentration1:10 Dilution1%10%2-Log Reduction in Supernatant Contentadditional reduction readily configurable Copyright Fresenius Kabi AGLOVO Data Presentation at ISCT Copyright Fresenius Kabi AGLOVO Timing & DetailsJanuary 15 - February 1 (US

7、 experimental release):Experimental hardware (not fully released, not UL approved)Experimental disposables (not fully released, not production units)SW version 1.0 (limited)April 1 (full release):Fully verified hardware (fully released, UL approved)Fully verified disposables (fully released, product

8、ion units)SW version 1.0 (limited)June 21 (sw 2.0 release):SW version 2.0 (launch) available for field installationDraft for internal use 9/25/20137LOVO Product FeaturesStandard vs. Customized ProcedureFeb. 1June 21Next GenPerform Standard Wash Procedure*Ability to configure multiple wash procedures

9、*8*Note that with the Limited Launch the Lovo will be able to perform only one type of procedure (Standard Wash Procedure). Upon set-up the user can configure default settings which will serve as the Standard Wash Procedure. LOVO Product FeaturesLog ReductionsFeb. 1June 21Next GenPerform a configura

10、ble number of log reductions (2-6)9The number of log reductions can be selected in the procedure set up screens.LOVO Product FeaturesVolume Processing- On or Off Scale OptionsFeb. 1June 21Next GenCapable of processing source product with a “Packed Cell Volume (PCV)” within a range of 0% to = 100mL t

11、o = 100mL to =50ml to =100ml to 5%LOVO Product FeaturesPCV & Auto DilutionFeb. 1June 21Next GenCapable of processing source product with a “Packed Cell Volume (PCV)” within a range of 0% to 5%*we anticipate that customers will be using a cell counter and will be know their concentrations or PCVLOVO

12、Product FeaturesWash/QS Media OptionsFeb. 1June 21Next GenUtilize a multiple wash media option* (ability to use a different solution for wash and dilution)The system will be capable of priming, washing and/or QSing with salineThe system will be capable of priming, washing and/or QSing with saline, d

13、imenthyl sulfoxide (DMSO), glycerol, bovine serum albumin (BSA), human serum albumin (HAS), and phosphate buffered saline (PBS)*The system shall allow operators to input final QS rate from =10mL/min to =150mL/min (to modate for DMSO)12*Note that the device and disposable kit are designed to allow fo

14、r the flexibility to allow for two different wash/dilution media to be used. A few customers have asked for the flexibility of washing with one media and diluting with another. To modate this, the device has two clamps (#1 and #2) and the disposable kit has two different lines/tubing, to modate this

15、 feature. However, at this time the software does not support this feature, but is anticipated will in the next version of software.*LOVO will be capable of priming, washing, and/or QSing with any solution with a specific gravity equal to 1. However, the user may use any solution they would like giv

16、en the system output is within their facilities standards.The disposable kit will be tested against Kabis leachables/extractables test program for variations of all the solutions listed.LOVO Product FeaturesProcedure Alarms & Data ManagementFeb. 1June 21Next GenThe user shall be able to stop and res

17、ume the procedure at anytime during the procedureDuring procedure set up the device will determine (and alarm) if there is adequate wash/QS media to complete the procedure given the inputs of starting/ending volumes, # of log reductions, etc.The device will store procedure related information (log f

18、iles), which can be exported using the UBS port on the back of the deviceThe device will be able to utilize DXT to export procedure information for use with other DMS systems13LOVO Product FeaturesDisposable System DetailsFeb. 1June 21Next GenDisposable kit will be sterilized using gamma irradiation and will be flexible