Transcript Carr Centritech Separation Systems

Carr UniFuge
Single-Use Separation
System
Customers Across the Globe
United States
Germany
Canada
France
Mexico
Austria
Brazil
Italy
U.K.
Japan
Sweden
Belgium
Australia
Denmark
Switzerland
The Netherlands
Wyeth
CELL SEPARATION
LIQUID/SOLID
2,400 L/hr
CARR P18
Powerfuge
CARR
ViaFuge V12
500 L/hr
CARR P12
Powerfuge
100 L/hr
Centritech
CELL
CARR
ViaFuge
&
UniFuge
10 L/hr
Centritech
LAB
450xg
CARR
P6 / Pilot
Powerfuge
Pilot
10,000xg
20,000xg
New Product Update
UniFuge
Single-Use Cell Harvesting
Technology
CONFIDENTIAL
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
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.
 Process rates allow for single shift harvesting
UniFuge®
Concept, Prototype & Testing
 Dec 2007 - Concept
 Mar. 2009 – Alpha unit mammalian cell test
 Oct. 2009 – Beta unit field trials begin
Alpha Prototype
Beta Prototype
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
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.
& concentrate
 Rotating mechanical seal, no
process contact
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
UniFuge®
Overview
Automatic pinch
valves
Feed In
Concentrate Out
Supernatant Out
Ultrasonic sensor
Peristaltic feed &
harvest pump
Single-use
pressure sensor
Onboard air supply
and sterile filter
Fiber optic level
sensor
Cooling jacket
supply connect
RPM Sensor
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
UniFuge® Pilot
Layout
25” (635mm)
57” (1448mm)
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 4LPM @ 70KPA; -25° to´+20° C
UniFuge®
Pilot Prototype
UniFuge®
Pilot Prototype
UniFuge®
Development Tests
Alpha Unit 3/4/09
Beta Unit 8/26/09
 Objective: separation
 Objective: separation
performance
 20L CHO Cells
performance, lysis, viability
 20L SF9 Cells
 Feed: 1.15x106 cells/ml
@ 95% viability
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.
 Feed: 6x106 cells/ml @
73% viability
 Three tested conditions
 1, 2 & 3 L/min
 2,000 x g
 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%
 Cell Capture Results
 1 L/min: 99.99%
 2 L/min: 99.9%
 3 L/min: 98.8%
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.
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.
UniFuge® Pilot
Customer Field Trails
Customer Trial #1 – preliminary results, awaiting formal summary

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.
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%
CHO
50L
4 L/min
3,000
95.4%
97.3%
Negligible
CHO
57L
5 L/min
3,000
98.6%
98%
2.97%
CHO
90L
4 L/min
3,000
96.2%
98.6%
-
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
CHO
10L
Sf9
10L
Baculovirus
infected
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.
Concentrations
Feed
Concentrate
Supernatant
1 Lpm
3.03x106
21.2x106
.003x106
1 Lpm
4.1x106
17.91x106
.049x106
UniFuge®
Summary
•
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®
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