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BioCision Product Overview Clinical
 

BioCision Product Overview Clinical

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    BioCision Product Overview Clinical BioCision Product Overview Clinical Presentation Transcript

    • BioCisionConsistent.Reproducible.Standardized. January 2011
    • CoolProducts CoolProducts enable biological sample consistency, reproducibility and standardization – user to user, site to site, trial to trial. CoolRack® CoolBoxTM CoolCell® Error-Free / Ice-Free / Alcohol-Free /Temperature Control Sample Handling Cell Freezing 2
    • Problem: Lack of Standardization“The lack of standardized, high-quality biospecimens has been widely recognized as one of the most significant roadblocks to the progress of cancer research.” - NIH / NCI / OBBR•  Worldwide effort to develop new standards for collecting, handling, and processing pre-analytical samples (blood, tissue, tumor, other biological specimens or sample materials) •  EU: http://www.devicelink.com/ivdt/archive/09/04/003.html •  NCI/NIH: http://biospecimens.cancer.gov/practices/default.asp •  NIH Office of Biorepositories and Biospecimen Research 2010 Symposium: http:// www.brnsymposium.com/meeting/brnsymposium/2010/ •  Duke: http://web.genome.duke.edu/cores/biorepository/protocols/ •  Molecular Epidemiology Workshop, Shanghai, 2008 3
    • Solution: CoolProductsReproducible and standardized cooling, (snap)freezing, thawing CoolRack in water bath CoolRack in dry ice Five consecutive freeze/thaw cycles using a CoolRack module show highly reproducible freezing and thawing profiles Biotech International (November 2010) 4
    • How does it work?•  CoolRack modules are made of a novel thermo- conductive alloy material •  Replaces “direct immersion” into temperature sources such as ice, dry ice, LN2, water bath•  Thermo-conductivity is the transfer of heat from higher temperature region to lower temperature region •  CoolRack on Ice: Heat from the relatively warmer CoolRack module is transferred to the ice (dry ice, LN2) until equilibrium is reached •  CoolRack in Water Bath: Heat is transferred from water bath toward relatively cooler CoolRack until equilibrium is reached•  CoolRack novel alloy evenly distributes the temperature across all wells providing very uniform and consistent temperature to all samples 5
    • CoolRack CoolRack Error-Free / Cooling, Freezing or Thawing 6
    • Ice Cooling“BioCision’s proprietary and patented portable bench top tools reducevariability and ensure consistency in clinical sample handling. Howsamples are handled prior to analysis is critical to the outcome of experiments inbasic and clinical research. "Biotech International” (November 2010) Current method of cooling samples in ice. The CoolRack modules instantly introduce random layout can result in mis-identification, organization and consistent temperature to all errors in aliquoting and temperature variability. samples (+/- 0.1oC). 7
    • CoolRackVersatile•  CoolRack rapidly adapts to any temperature •  from -150oC through 100oC+ •  cooling (ice), snap-freezing (dry ice, LN2), •  thawing/incubating (water bath, heat block)Uniform temperature•  +/-0.1oC temp uniformity to all wells•  standardize assay to assay, user to use, site to sitePatented novel alloy construction•  very rapid thermo-conductivity/adaptivity•  temperature assurance – no mess, no uncertainty 8
    • ModularFor a variety of biological specimens CoolRack tube holders CoolSink Plate holders CoolTray platforms 9
    • VersatileFor a variety of applications -150oC -78oC 0o to 4oC 37oC + Liquid Nitrogen Dry Ice Ice Water Bath •  Eliminate direct immersion •  Replaces direct contact with •  Gain organization & stability •  Keeps tubes out of water – into LN2 dry ice in ice reduced contamination, labels •  All tubes are upright •  Eliminates ethanol bath on •  Even temperature distribution stay dry •  Same freezing profile for all the bench – cost savings, to all samples even as ice melt •  Consistent thawing profile for samples reduced hazard & waste •  Labels stay dry and legible for all samples •  ThermalTray provides •  CoolRack PF provides equal better sample identification •  All wells at identical elevation of samples & or faster snap-freezing than •  Reduced risk of sample temperature - eliminates edge increased distance between ethanol slurry contamination effect on multi-well plates hands and LN2 •  Standardized freezing - •  Rapidly goes from ambient to •  Stable support of tubes & •  Rapidly adapts from ambient minimized standard deviation in <4oC in 90 seconds plates (25oC) to LN2 temp (-150oC) in freeze profiles • Using ThermalTray, 10-15 12-14 minutes •  Improved work flow hours of <4oC with one pan of •  Adapts to -78oC in 5-7 ice minutesBioCision’s tools are unique and replace very rudimentary methods of sample preservation (freezing, snap-freezing) and handling (cooling, thawing) 10
    • CoolRack Performance Cooling Rate - Ice §  Ambient to < 4oC in 60-90 seconds §  4-6 hours of use when placing CoolRack directly on ice §  Up to 14 hours cooling with a single pan of ice with ThermalTray Cooling rate on ice Snap-Freezing Rate – Dry Ice §  Equal or better freeze rate than dry ice/ ethanol bath §  No alcohol required – cost savings, reduced hazard §  Consistent freeze profile for all samples Freeze rate on dry ice Standard deviation 11
    • CoolSink PerformanceØ  Multi-well plates placed directly on ice for cooling do not achieve critical < 4oC temperature in any of the wells (Fig. 2, A)Ø  CoolSink modules evenly distribute the ice temperature to all wells (Fig. 2, B and C) •  All wells are <4oC •  Curvature of the plate accounts for center well variability (Fig.1) Figure 1. Variance in height of undersurface of 96-well flat- Figure 2. Final equilibrium well temperature for a 96-well flat bottom plate bottom plate. The x and y axes represent the well number in direct contact with (A) crushed ice, (B) CoolSink 96Fwith a dry interface, and letter, and the z axis represents the relative deviation of and (C) CoolSink 96F with aqueous conductive medium in the interface. the surface in units of 0.001 in. Data was collected using a Colors represent 0.5°C temperature intervals of the corresponding plate ball dial indicator with a resolution of 0.0001 in. wells. The white cell represents the well that was fitted with the thermocouple probe. Published in Biotechniques, November 2010 12
    • Kits and Accessories•  CoolBox •  Ice-free cooling container•  CoolSystem •  Include ThermalTray LP, CoolRack(s), large ice pan•  Accessories •  Ice pans •  Rectangular (9L & 4L) and round (4L) o •  Temperature strips (1-8 C) •  LCD display adheres to all thermo-conductive modules •  CoolMat histology cutting mat •  Protects surface of ThermalTray and scalpel blade 13
    • Customer Feedback - CoolRackSteffan Vartanian - GenentechDon’t you hate it when you spend all morning preparing RNA or harvesting lysates, only tocome back from lunch to find your precious samples drowning in a pool of melted ice? ……But after using the Thermal Tray and CoolRack a few times, my soggy-sample days areofficially over! Not only do these tools keep your samples chilled for hours, but they alsokeep everything organized, safe, and secure. BioCisions products are very well made, welldesigned, and just plain look cool. Highly recommended!Hans B - Perkin ElmerWe have been using the CoolRack for snap freezing our samples for the past weeks withgreat success. Since we were on a tight schedule we performed some validation in houseand were very pleased with the results. 14
    • CoolBox CoolBox Ice-Free / Sample Handling 15
    • CoolBoxConsistent ice-free cooling and freezing•  cartridges provide up to 10 hours of ice-free cooling or freezing•  continuous +/- 0.1oC consistency to all wellsVersatile•  five temperature options using cartridges, dry ice or LN2•  portable•  accommodates variety of tubes & platesHighly recommended for•  PCR and RNA work, cell culture, cooling in biosafety cabinet, GMP/GLP suites and vivarium, bio-hazardous containment, short transport 16
    • CoolBox 30 & CoolBox Microplate CoolBox Microplate System • Ice-free SBS-format plate & tube cooling & freezing o • Includes CoolBox, lid, blue +2 C cartridge • Accommodates all SBS format modules - CoolSinks, CoolRack PCRs, CoolRack 1mlx96 • Sold separately OR with CoolRack/CoolSink CoolBox 30 System• Ice-free tube cooling / freezing o• Includes CoolBox, lid, blue +2 C cartridge, redstage, purple insulator pad• Accommodates all 30-well CoolRacks• Sold separately OR with CoolRack 17
    • CoolBox Performance mmmm -25oC with thermal regulator pad placed between CoolRack and dry ice Snap-freezing at -78oC with CoolRack directly on 200cc dry ice NOTE: Performance may vary depending on ambient conditions, starting temperature and other specific set-up criteria. See instructions for complete information. 18
    • CoolBox Advantage CoolBox Gel-Filled Container Well-to-well Temperature Variance: Well-to-well Temperature Variance: +/-0.1oC Up to 4oC Cooling Media: Cooling Media: LN2, Dry ice, Wet ice, Cartridge Gel Temperature range: Temperature range: -150oC through +150oC Fixed at -20oC or 0oC Tube & Plate Formats: Tube & Plate Formats: 0.5ml conical, 1.5ml conical, 1.5-2.0ml 0.5ml conical, 1.5ml conical, PCR tubes cylindrical, 12.5mm dia cryos, mass spec tubes, PCR 96- and 384-well plates, 6-, 12-, 24-, 48-, 96-well plates Cooling Duration: Cooling Duration: 10h (2ºC), 6h (-12ºC), 5h (-25ºC), 8h (0ºC), 3h (-21ºC) 6h (-78ºC) Down Time: Down-Time: None – switch cartridge with another 4-6 hours to re-freeze gel-filled tube rack frozen one from the freezer or replenish dry ice, LN2 CoolBox provides temperature uniformity and versatility 19
    • Customer Feedback - CoolBoxFraser Moss Ph.D. - Case Western Reserve University, Dept. of Physiology andBiophysics, President Scientist SolutionBioCision has now eliminated the ice factor and have the CoolBox in which you can keep the96 well CoolRack…..Im using it to keep my RNA cold for oocyte injections right now. Ill beusing it to assemble my PCR reactions in the not to distant future. This has been a great newlittle toy to have on the bench recently because our departmental ice machine broke in Apriland still is not fixed!Laura Matthews - Sarah Cannon Research Institute (SCRI)I am writing regarding the demo CoolRack and CoolBox that we have been testing. They areboth great products. The CoolRacks have eliminated the mess of mushy cardboard freezerboxes. The samples also freeze much faster in the CoolRacks. The CoolBox was especiallyhelpful in the transport of fresh biopsies on dry ice from one location to another 20
    • CoolCell CoolCell Alcohol-Free / Cell Freezing Container 21
    • CoolCellHighest reproducibility•  -1oC/minute freeze rate•  Every freeze run is exactly the same•  Identical freezing profiles every timeHighest cell viability•  Cell lines, PBMC, primary cells, stem cells, yeastAlcohol-free•  No alcohol – no fluids•  No on-going alcohol expense or waste•  No maintenance•  No variability due to changes in alcohol 22
    • CoolCellEliminates alcohol-induced freezing variation•  Many researchers currently use alcohol-filled containers to achieve a -1oC/minute freeze rate when freezing cells in -80oC freezer Alcohol-filled container•  The alcohol must be replaced every 5 uses because the alcohol changes each time it’s frozen •  Alcohol absorbs moisture and evaporates•  CoolCell uses no alcohol (no fluids) •  Nothing changes •  Identical cell freezing results every time 23
    • Reproducible Results Five consecutive freeze cycles in CoolCell show fusion time and cooling profiles are identical every time 24
    • High Cell Viability In primary human cells, CoolCell significantly outperforms 25
    • CoolSystemTM CRYO•  Kit for ice-free vial preparation in a laminar flow hood & alcohol-free cell freezing in a -80oC freezer •  CoolBox CFT provides ice-free 0-4oC work station for 30 cryo vials and allows one-handed vial opening and closing •  CoolCell provides alcohol-free and standardized cell freezing CoolSystem CRYO (#BCS-142) includes CoolBox CFT30 System and CoolCell 26
    • CoolCell Advantage CoolCell Alcohol-Filled Container Very consistent -1oC/min rate Inconsistent freeze rate • All vials have uniform freeze rate • Each run is different due to alcohol every time degradation • Radially symmetric – design enables • Two circles of wells – different freeze rates consistency for each circle No alcohol Requires 250ml alcohol • No hazardous fluids • Replace alcohol every 5 uses (250ml) • Solid core and insulation design • Keep track of # of uses • No pre-cooling required • Alcohol degrades slightly each time it s used • Pre-cool alcohol in refrigerator Cost savings ~$338/year maintenance per unit • No maintenance cost • Change alcohol weekly (~$6/wk) • Pays for itself quickly • Dispose haz waste (~$0.75/wk) • 10 units = $3,380 to use EVERY YEAR Lid opens easily Screw cap very difficult to remove when • Not cold to the touch when removing frozen from the -80C freezer • Protective glove required when handling frozen unit Better cell viability Good cell viability Ready to use again in 5 minutes Takes >1 hour for device to return to room temp for re-use Low impact on freezer Large thermal mass impacts local • 1/3 the heat impact on freezer freezer area compared to alcohol-filled units • Large heat capacity removed from alcohol impacts nearby samples 27
    • Customer Feedback - CoolCellRohit G. - Stanford UniversityWe run a registry, in which large amounts of PBMCs are processed for long-termcyropreservation.………Overall, the CoolCell has proven to us to set a new bar incryopreservation.Srujan P. - Merck Pharmaceutical, Vaccine ManufacturingI have already purchased 21 CoolCells, I have obtained a CoolBox, and I recently ordered a96well flat bottom CoolCell system. All these will be used for our assays…. I already passedon my evaluation of the cool cell and the other groups are pretty excited and are going to usethem.Sam Knight - Ceramisphere (Australia)Purely altruistically, I wanted to mention that one big advantage of the CoolCell is that you canuse dry ice to do your freezing if you dont have a -80. I spent nearly a year getting terribleviability-recovery on cell freezing with dry ice (in an alcohol device) followed by storage in LN2,and this on HeLa cells which arent exactly hard to store. I then bought a CoolCell and now Ican just use standard cryo-preservation techniques (DMSO, 20% NBS) and get nearly 100%viability on thawing. 28
    • Summary 29
    • Standardizing Clinical Sample Handling •  Clinical sample handling has become increasingly important •  growing number of multi-national clinical trials •  increasing use of biomarkers •  the move toward personalized medicine. •  BioCision products address common and often overlooked inconsistent procedures in every laboratory •  Non-standardized methods of cooling/freezing/thawing •  Consistency. Reproducibility. Standardization. •  Test to test •  Researcher to researcher •  Lab to lab •  Site to site
    • Visit www.biocision.com•  Product data & brochures•  Applications•  Technical articles•  Videos•  Customer testimonials•  Customization 31
    • Genentech Amgen Pfizer Roche Harvard MIT CalTech UCSF Glaxo Bristol Myers Squibb NovartisTranslational Genomics Gilead Sciences Merck MedImmune ATCC Genpharm Elan PharmaceuticalsCentocor Boehringer Ingelheim Oncomed NIH/NCI Takeda Pharmaceuticals CDC Covance XOMA Thank youQuest Diagnostics Otsuka America Pharmaceuticals Salk Institute Burnham Institute Scripps InstituteStanford University Yale Genzyme EMD Serono Shire HGT Alnylam Wyeth Cell-SystemsJackson Labs Beth Israel Deaconess Hospital HHMI Whitehead Institute Harvard Systems BiologyExelixis Charles River Labs Sanofi Pasteur Penn State Lawrence Berkeley Lab Batelle UC BerkeleyCedars Sinai Hospital Cleveland Clinic IDEXX Biogen Perkin Elmer Genetics Blood Systems Research Inst. Copyright 2011. Patents pending. All rights reserved.