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Carr UniFuge Single-Use Separation System. Customers Across the Globe United States Germany Canada France Mexico Austria Brazil Italy U.K. Japan Sweden.

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Presentation on theme: "Carr UniFuge Single-Use Separation System. Customers Across the Globe United States Germany Canada France Mexico Austria Brazil Italy U.K. Japan Sweden."— Presentation transcript:

1 Carr UniFuge Single-Use Separation System

2 Customers Across the Globe United States Germany Canada France Mexico Austria Brazil Italy U.K. Japan Sweden Belgium Australia Denmark Switzerland The Netherlands

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4 New Product Update UniFuge Single-Use Cell Harvesting Technology CONFIDENTIAL

5 Design Objectives Robust, single use cell harvesting centrifuge Scalable platform Harvest capacity of 10L to 2,500L bioreactor Pilot ≈ 3L/min with1.5L cell volume collection Production ≈ 20L/min with 40L cell volume collection Gamma irradiated single use liner Fully automated processing High recovery of cells with minimal cell lysis Process rates allow for single shift harvesting CONFIDENTIAL INFORMATION DISCLOSURE FOR ‘A’ The information contained in this document contains privileged and confidential information. It is intended only for the use of the person(s) named above. If you are not the intended recipient, you are hereby notified that any review, dissemination, distribution or duplication of this communication is strictly prohibited.

6 UniFuge ® Concept, Prototype & Testing Dec Concept Mar – Alpha unit mammalian cell test Oct – Beta unit field trials begin Alpha PrototypeBeta Prototype

7 Solid Bowl Centrifuge Reinforced & contained flexible single- use component Semi-continuous, automated cell processing Programmable feed & harvest cycles Intermittent cell concentrate removal Closed loop operation Gamma irradiated disposable liner Sterile connections for feed, centrate & concentrate Rotating mechanical seal, no process contact UniFuge ® Design Concept CONFIDENTIAL INFORMATION DISCLOSURE FOR ‘A’ The information contained in this document contains privileged and confidential information. It is intended only for the use of the person(s) named above. If you are not the intended recipient, you are hereby notified that any review, dissemination, distribution or duplication of this communication is strictly prohibited.

8 UniFuge ® Single Use Component Rigid + flexible components Tube set is integrated as part of single use component Terminally sterilized (gamma) Complies with: ISO USP & Class VI plastics Polycarbonate Polyurethane Polypropylene C-Flex Silicone

9 UniFuge ® Overview Feed In Concentrate Out Supernatant Out Ultrasonic sensor Peristaltic feed & harvest pump RPM Sensor Cooling jacket supply connect Onboard air supply and sterile filter Fiber optic level sensor Automatic pinch valves Single-use pressure sensor

10 Auto & manual modes Setup integrity test mode Controlled parameters Bowl speed / G-force Feed flow rate Fill volume (flow rate / time) Cycle time Discharge time Number of cycles Monitored Parameters Supernatant line pressure Air pressure Vibration (accelerometer) Calibration screens Alarms UniFuge ® Automated Processing

11 UniFuge ® Pilot Layout 57” (1448mm) 25” (635mm) Process connections: Electrical: 230VAC, 1 phase, 50/60Hz, 15A Feed supply: up to 4Lpm, ½” weldable tubing Cell concentrate discharge: ½” weldable tubing Supernatant discharge: ½” weldable tubing Cooling (optional): ¼” FNPT 70KPA; -25° to´+20° C

12 UniFuge ® Pilot Prototype

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14 Alpha Unit 3/4/09 Objective: separation performance 20L CHO Cells Feed: 1.15x % viability Three tested conditions 1, 2 & 3 L/min 2,000 x g Cell Capture Results 1 L/min: 99.99% 2 L/min: 99.8% 3 L/min: 98.6% UniFuge ® Development Tests Beta Unit 8/26/09 Objective: separation performance, lysis, viability 20L SF9 Cells Feed: 6x % viability Three tested conditions 1, 2 & 3 L/min 2,000 x g Cell Capture Results 1 L/min: 99.99% 2 L/min: 99.9% 3 L/min: 98.8% CONFIDENTIAL INFORMATION DISCLOSURE FOR ‘customer’ The information contained in this document contains privileged and confidential information. It is intended only for the use of the person(s) named above. If you are not the intended recipient, you are hereby notified that any review, dissemination, distribution or duplication of this communication is strictly prohibited.

15 UniFuge ® Supernatant Separation Results CONFIDENTIAL INFORMATION DISCLOSURE FOR ‘customer’ The information contained in this document contains privileged and confidential information. It is intended only for the use of the person(s) named above. If you are not the intended recipient, you are hereby notified that any review, dissemination, distribution or duplication of this communication is strictly prohibited.

16 UniFuge ® Prototype Turbidity CONFIDENTIAL INFORMATION DISCLOSURE FOR ‘customer’ The information contained in this document contains privileged and confidential information. It is intended only for the use of the person(s) named above. If you are not the intended recipient, you are hereby notified that any review, dissemination, distribution or duplication of this communication is strictly prohibited.

17 Customer Trial #1 – preliminary results, awaiting formal summary Objective: Harvest with recovery of viable cells UniFuge ® Pilot Customer Field Trails Cell Line VolumeFlow rateG-forceFeed Viability Harvest Viability % Loss in supernatant CHO56L3 L/min2,00099%~98%1.68% CHO50L4 L/min3, %97.3%Negligible CHO57L5 L/min3, %98%2.97% CHO90L4 L/min3, %98.6%- CONFIDENTIAL INFORMATION DISCLOSURE FOR ‘customer’ The information contained in this document contains privileged and confidential information. It is intended only for the use of the person(s) named above. If you are not the intended recipient, you are hereby notified that any review, dissemination, distribution or duplication of this communication is strictly prohibited.

18 Customer Trial #2 – preliminary results, awaiting formal summary Objective: Clarification & Harvest from Wave Bag BR UniFuge ® Pilot Customer Field Trails Cell line Batch size Flow rate Concentrations FeedConcentrateSupernatant CHO10L1 Lpm3.03x x x10 6 Sf9 Baculovirus infected 10L1 Lpm4.1x x x10 6 CONFIDENTIAL INFORMATION DISCLOSURE FOR ‘customer’ The information contained in this document contains privileged and confidential information. It is intended only for the use of the person(s) named above. If you are not the intended recipient, you are hereby notified that any review, dissemination, distribution or duplication of this communication is strictly prohibited.

19 Benefits –Centrifugation Improved separation performance means less downstream processing Better suited for high titers – no blinding or fouling of filters –Single Use Technology Lower cost due to less cleaning/sterilization - No CIP/SIP required Less product losses due to contamination –Programmable automatic processing Variable separation force Optimize feed flow rates Programmable harvest cycle time –Capable of recovering and concentrating viable cells –Reduced downstream filtration –Scalability, Pilot -> Production  UniFuge ® Summary

20 UniFuge ® Next Steps Unit(s) available for field testing in US and Europe Typical field trial period is for one (1) week and includes on site technical support Each customer will purchase the disposable liner(s) needed for testing The beta test single-use components will not be gamma irradiated Unifuge Pilot is available for sale, estimated delivery is 12 weeks


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