BW Organization Overview
Robert H. Chapman, CEO • Revenues $1.2 Billion • Associates 5,647
Our Operating Division
Pneumatic Scale Angelus
 In business since 1895
 600+ team members
 Three manufacturing sites
 ...
Continuous Flow
Centrifuge Platforms
Disposable Single Use Systems
UniFuge®
 Low shear viable cell recovery to 3,000 x g
...
CARR UniFuge
UniFuge® Single Use Centrifuge
UniFuge®
Single Use Component
 Rigid + flexible components
 Integrated single use tube set,
sensor & air filter
 Gamma ...
UniFuge®
Pilot Overview
Buffer In
Feed In
Concentrate Out
Supernatant Out
Peristaltic feed &
harvest pump
Cooling jacket
s...
UniFuge®
Process Description
CONFIDENTIAL INFORMATION
The information contained in this
document contains privileged and
c...
UniFuge®
Process Visualization
UniFuge®
Process Buffer Options
■ Buffer Chase
■ Bowl is kept spinning, solids held to sides
■ Buffer is run in lieu of fe...
UniFuge® Pilot
Layout
 Electrical: 120/230VAC, 1 phase, 50/60Hz, 15/7.5A
 Pneumatic: 80-100 PSI, 10 SCFH
 Feed supply: ...
I/O and Controls
I/O
 Analog- Rpm, pressure, pumps ,set points and volumes
 Digital- On/off signals, such as air detecti...
Overview of applications
The large scale economic collection of proteins is increasingly an important problem for
the Biot...
 UniFuge is a Single Use tube bowl centrifuge based on
proven platforms. In one application, 1600 hours or 440
runs witho...
0.0
0.5
1.0
1.5
2.0
2.5
0 5 10 15 20
ODat600nm(AU)
Centrifuge Cycle Run Time (min)
Inline PendoTECH Monitor Offline Grab S...
 Objective: Harvest with recovery of viable cells
Cell Line Volume Feed Flow
rate
G-force Feed
Viability
Harvest
Viabilit...
Particle size distribution of 3LPM SF9 harvest showing no lysate
Feed, Centrate, Solids - UniFuge
UniFuge Vs. Bottle centrifuge - infected mrc5 cells - Vaccine
 Increased cell recovery- 30% higher .
 30 % increase in p...
The UniFuge VS. depth filtration.
• Filter reduction by 88%. With UniFuge @ 3000 x g compared to depth
filtration. Through...
0
20
40
60
80
100
120
140
160
ntu pcv-feed Throughput L/m2
2lpm
3 lpm
4lpm
feed
CHO DATA
CHO DATA- 1-4 LPM
Run G-Force Cycles
Feed Rate
(LPM)
Total
Volume
Processed Time Sample
Sample
Collected at
Volume (L) NTU...
UniFuge Customers
Application Review
Let us put our knowledge and
experience to work on your application
Contact Information
Paul Motulewicz...
20130607   UniFuge
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20130607 UniFuge

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The attached powerpoint is an introduction to Pneumatic Scale Angelus' single use centrifuge, the UniFuge. The entire process contact fluid path is made from disposable USP class VI Polymers and is gamma irradiated. This centrifuge is suitable for bioreactor clarification, media exchange, cell banking, viable cell harvesting, cell washing and a host of other applications.

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20130607 UniFuge

  1. 1. BW Organization Overview Robert H. Chapman, CEO • Revenues $1.2 Billion • Associates 5,647
  2. 2. Our Operating Division Pneumatic Scale Angelus  In business since 1895  600+ team members  Three manufacturing sites  55,000+ machines installed  Product lines manufactured  Centrifuges (CARR-Centritech) Stow, OH Cuyahoga Falls, OH Los Angeles, CA Clearwater, FL Worcester, UK Antwerp, Belgium Berlin, Germany
  3. 3. Continuous Flow Centrifuge Platforms Disposable Single Use Systems UniFuge®  Low shear viable cell recovery to 3,000 x g  Batch and fed batch harvesting  Scalable: 250ml/min → 1,000L/hr Centritech ®  Low shear cell harvest, perfusion, media exchange  Scalable: 250ml/min → 150 L/hr CIP/SIP cGMP CIP/SIP Cleanable Systems CARR Powerfuge ® - up to 20,000 x g – Bacteria, fungi, proteins, sub-micron particles – Scalable: 250ml/min → 1,700 L/hr CARR ViaFuge ® - Low shear cell harvest – Mammalian, insect, plant cells (>99% viability) – Scalable: 250ml/min → 2,400 L/hr
  4. 4. CARR UniFuge
  5. 5. UniFuge® Single Use Centrifuge
  6. 6. UniFuge® Single Use Component  Rigid + flexible components  Integrated single use tube set, sensor & air filter  Gamma irradiated  Class VI materials:  Polyurethane  Polypropylene  C-Flex  Silicone
  7. 7. UniFuge® Pilot Overview Buffer In Feed In Concentrate Out Supernatant Out Peristaltic feed & harvest pump Cooling jacket supply connections Onboard air supply and sterile filter Automatic pinch valves Single-use pressure sensor Touch screen interface
  8. 8. UniFuge® Process Description CONFIDENTIAL INFORMATION 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 not the intended recipient, you are hereby notified that any review, dissemination, distribution or duplication of this communication is strictly prohibited. Feed/concentrate tube Centrate tube Cap Upper flange Flexible chamber Aluminum bowl Core Lower flange Aluminum Bowl ■ Bioreactor is connected to the module through a peristaltic pump via the feed tube ■ No shear feed/Harvest design ■ Mass balance > 99% ■ Up to 32E9 Cells/mL are gently concentrated at the bowl wall ■ Clarified supernatant is discharged from centrate tube at 1-2 psi without foaming. ■ Concentrate is automatically recovered by reversing Feed pump to remove pellet. ■ 1.7 liter pellet ■ Process steps are automated ■ 750-4000 G ■ .25-6 LPM feed Feed Supernatant Concentrate
  9. 9. UniFuge® Process Visualization
  10. 10. UniFuge® Process Buffer Options ■ Buffer Chase ■ Bowl is kept spinning, solids held to sides ■ Buffer is run in lieu of feed to push out remaining supernatant ■ Rinse ■ After normal discharge, buffer is introduced to bowl and remaining solids ■ Centrifuge spins up and back down ■ Buffer and diluted remains are pumped out ■ Process steps are automated Supernatant Buffer Supply Feed Supply Concentrate Supernatant Feed, Concentrate, Buffer Buffer Chase Buffer Rinse
  11. 11. UniFuge® Pilot Layout  Electrical: 120/230VAC, 1 phase, 50/60Hz, 15/7.5A  Pneumatic: 80-100 PSI, 10 SCFH  Feed supply: up to 4L/min, ½” weldable tubing  Cell concentrate discharge: ½” weldable tubing  Supernatant discharge: ½” weldable tubing  Process Cooling (optional): 1/2” sanitary; max flow: 1L/min; max pressure: 0.68bar (10psi); temp range: -25 C to 20 C Height 46” (117cm) Weight: 640 lbs (291kg)
  12. 12. I/O and Controls I/O  Analog- Rpm, pressure, pumps ,set points and volumes  Digital- On/off signals, such as air detection, pinch valves, e stop…  signals are sent via Ethernet to a SCADA system or chart recorder.  signal repeating (discrete, 4-20mA, etc...) to data storage device  Profibus and Modbus also available Controls  System Security and passwords  PLC -AB Compaq logics  HMI-Panel view 1000 ,10.4 inch  Delta V integration available
  13. 13. Overview of applications The large scale economic collection of proteins is increasingly an important problem for the Biotechnology industry. Generally, proteins are produced by cell culture, engineered to produce the proteins of interest by insertion of a recombinant plasmid containing the gene for that protein. Since the cell lines used are living organisms, they must be fed with a complex growth medium. Separation of the desired protein from the fermentation broth pose challenges. Advances in cell culture techniques have greatly increased the cell populations and titers of the target proteins in culture fluid. This increase in upstream efficiency has lead to a bottleneck in downstream processing at the cell-harvest stage. Cell harvesting or clarification of the harvested cell culture fluid is an important process. When the product is extracellular, clarification is used to separate the product from the cells and cellular debris. When the finished product is the cells or intercellular proteins/virus cell harvesting is performed. Most Biopharm companies today are seeking ways to integrate this single use technology (clarification/harvest) into the single use process path. The UniFuge, single use centrifuge is fits very well into the single use initiative. This presentation will compare the UniFuge to several cell harvest/clarification processes.
  14. 14.  UniFuge is a Single Use tube bowl centrifuge based on proven platforms. In one application, 1600 hours or 440 runs without a single production batch loss.  Mammalian Applications: CHO, SF9, MD, HAL2, mrc5...  Very low shear inlet ,and no shear discharge  Supernatant clarification  Sterile cell Harvest  Pilot, Clinical & Manufacturing processes:  Process Feed rates 0.25 – 6 L/min (to 360 L/hr) UniFuge-Single Use Centrifuge
  15. 15. 0.0 0.5 1.0 1.5 2.0 2.5 0 5 10 15 20 ODat600nm(AU) Centrifuge Cycle Run Time (min) Inline PendoTECH Monitor Offline Grab Sample Cycle Time (min) Inline OD800 (AU) Offline OD880 (AU) 2.6 0.633 0.1903 6.3 0.684 0.2021 10.0 0.687 0.2087 12.5 0.701 0.2163 14.9 2.4 1.526 UniFuge: Feed Breakthrough with OD readings 95% bowl fill.
  16. 16.  Objective: Harvest with recovery of viable cells Cell Line Volume Feed Flow rate G-force Feed Viability Harvest Viability Feed/cent Nephelometric Turbidity Units (NTU) HAL2 18L 1.5 LPM 2,500 93% 92% MRC5 infected 13L 1 LPM 3,000 68% 70% CHO 48 L 4 LPM 3,000 93% 92% 3786/167 Viability Table - UniFuge
  17. 17. Particle size distribution of 3LPM SF9 harvest showing no lysate Feed, Centrate, Solids - UniFuge
  18. 18. UniFuge Vs. Bottle centrifuge - infected mrc5 cells - Vaccine  Increased cell recovery- 30% higher .  30 % increase in protein titer.  No manual manipulation- pipetting, hoods, respirators  No Cell less from manual manipulation  Closed processes UniFuge Vs. Bottle Centrifuge
  19. 19. The UniFuge VS. depth filtration. • Filter reduction by 88%. With UniFuge @ 3000 x g compared to depth filtration. Throughput 400 L/2.6 m2 • 5% greater protein recovery. Estimated protein loss is 7-8% with depth filtration (entrainment). One can argue, flush out filter, but this adds buffer volume and additional concentration step: time additional filtration. • Set up /tear down time is 15 minutes for the UniFuge. • Space reduction- UniFuge replaces 2/3 of filter skids. • Disposal of filtration and Weight of wet filters VS. 1KG empty module CHO Process
  20. 20. 0 20 40 60 80 100 120 140 160 ntu pcv-feed Throughput L/m2 2lpm 3 lpm 4lpm feed CHO DATA
  21. 21. CHO DATA- 1-4 LPM Run G-Force Cycles Feed Rate (LPM) Total Volume Processed Time Sample Sample Collected at Volume (L) NTU % Solid vmax 1 3000 1 1 16 - Load - 5762 20 Centrate 16 101 - Pellet - - 47 2 3000 1 2 16 - Load - 2975 13 Centrate 16 91 - Pellet - - 43 3 3000 1 3 16 - Load - 2527 12 Centrate 16 94.6 - Pellet - - 50 4 3000 1 4 16 - Load - 1850 10 Centrate 16 91 - Pellet - - 47 5 3000 1 2 16 - Load - 1634 11 Centrate 16 125 - Pellet - - 44 6 3000 3 3 45 ? Load - 1529 13 Centrate (Composite) 45 147 - Pellet - - 38 Load (At End) - 2187 16 7 3000 3 3 45 27 Load - 2480 12 Centrate (Cycle 3) 8 179 - Pellet - - 40 8 3000 3 4 48 25.6 Load - 3786 17 140 Centrate (Cycle 1) 8 164 - 142 Centrate (Cycle 2) 8 176 - Centrate (Composite) 48 172 - Pellet - - 35 Feed Run Filter Volume Filtered (mL) Throughput (L/m2) NTU of Pool 4 8 Vendor 2 Filter 1 365 140.38 10.2 4 8 Vendor 2 Filter 2 370 142.31 5.85
  22. 22. UniFuge Customers
  23. 23. Application Review Let us put our knowledge and experience to work on your application Contact Information Paul Motulewicz – Senior Account Executive 727 385 9794 Mobile paul.motulewicz@psangelus.com 5320 140th Ave.nue North Clearwater, FL 33760 727-535-4100 www.psangelus.com www.barry-wehmiller.com

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