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

4. UniFuge Single-Use Cell Harvesting Technology CONFIDENTIAL
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 Prototype
Beta Prototype

7. UniFuge® Design Concept
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
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 10993
USP <87> & <88>
Class VI plastics
Polycarbonate
Polyurethane
Polypropylene
C-Flex
Silicone

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

10. UniFuge® Automated Processing
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

11. UniFuge® Pilot Layout Process connections:
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

13. UniFuge® Pilot Prototype

14. UniFuge® Development Tests
Alpha Unit 3/4/09
Objective: separation performance
20L CHO Cells
Feed: 1.15x106 95% 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%
Beta Unit 8/26/09
Objective: separation performance, lysis, viability
20L SF9 Cells
Feed: 6x106 73% 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. UniFuge® Pilot Customer Field Trails
Customer Trial #1 – preliminary results, awaiting formal summary
Objective: Harvest with recovery of viable cells
Cell Line
Volume
Flow rate
G-force
Feed Viability
Harvest Viability
% Loss in supernatant
CHO
56L
3 L/min
2,000
99%
~98%
1.68%
50L
4 L/min
3,000
95.4%
97.3%
Negligible
57L
5 L/min
98.6%
98%
2.97%
90L
96.2% -
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. UniFuge® Pilot Customer Field Trails
Customer Trial #2 – preliminary results, awaiting formal summary
Objective: Clarification & Harvest from Wave Bag BR
Cell
line
Batch
size
Flow
rate
Concentrations
Feed
Concentrate
Supernatant
CHO
10L
1 Lpm
3.03x106
21.2x106
.003x106
Sf9
Baculovirus infected
4.1x106
17.91x106
.049x106
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.  UniFuge® Summary Benefits Centrifugation Single Use Technology
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 

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