Single-use technologies

Modular perfusion workflow
Unlock the power of perfusion withpreconfigured hardware and disposable systems

Unlock the power of perfusion
Properly specified systems based on 50–500 L S.U.B.s
allow rapid deployment with hassle-free compatibility
We have developed a module-based perfusion system that provides the building blocks to establish and run a50–500 L continuous manufacturing process on your production floor. These pre-engineered modules combine
to form a perfusion workflow to support high cell density and provide flexibility and configurable solutions tomeet your specific needs.

Built for continuous bioproduction
Our modular perfusion workflow is ideally suited for high-density
seed train intensification or as a compact production-scalebioreactor system operating at media exchange rates of 1–2
vessel volumes per day. This system allows you to realize theadvantages of continuous cell culture production while helping
to minimize development time and costs.

bioprocessing. This application-focused modular system enables
completion of most process steps, including:• Scalable media preparation and filtration• Scalable sterile media hold• Sterile fluid transferSingle-use systems enable
continuous processing• Cell growth and monitoring

Thermo Scientific™ Single-Use Bioreactors (S.U.B.s), single-use
mixing systems, and single-use storage solutions are widelyused throughout the bioproduction industry. The combinationof our hardware with Thermo Scientific Aegis 5-14 Bioprocess™

2

Containers (BPCs) provides a trusted backbone for continuous™

• Permeate transfer and pooling• Cell bleed

Bioreactor enhancements and features
for reliable perfusion
The Thermo Scientific™ HyPerforma™ Single-Use Bioreactor(S.U.B.) is our standard, fully functional bioreactor vessel to help
ensure consistency in your perfusion workflows.
• Enhanced mixing systems, using a larger impeller• Scalable and CO2- and O₂-balanced sparging solution

for enhanced mass transfer• Foam sensing for automated foam control• Simple connection to either alternating tangential flow (ATF)• Loads cells for accurately controlled liquid volume• Integrated with best-in-class Emerson™ DeltaV™

control systems• S.U.B. hardware ports specific to ATF perfusion systems– 50­–250 L S.U.B. vessel with diameter cutout

at 36 in. above floor for ATF6
– 500 L S.U.B. vessel with diameter cutout

at 41 in. above floor for ATF10

or tangential flow filtration (TFF) technologies• Scalable from 50 L pilot scale to 500 L production

working volumes• Simple integration of conventional sensors, or easily

customizable with single-use sensors

3

DynaDrive S.U.B.
Next-generation bioreactor
for superior performance
The Thermo Scientific™ DynaDrive™ Single-Use Bioreactor (S.U.B.)
is our latest advancement in S.U.B. technology that offers better
performance and is scalable to larger volumes than previousbioreactors. This cube-shaped tank, with its unique stirred-tank
design, utilizes a novel drive train with multiple impellers, which
results in exceptional mixing capabilities and mass transfer.
This makes it ideal for the high–cell density applications seen inperfusion cell culture workflows.
As with the standard HyPerforma S.U.B. offerings, the DynaDrive
S.U.B. is compatible with conventional or single-use sensors,connects to either TFF or ATF perfusion systems, includes
standard S.U.B. load cells and foam sensor, and easily integrates
with Thermo Scientific™ HyPerforma™ G3Lite or G3Pro controllers.
Additionally, the DynaDrive S.U.B. offers some key advantages:• Hardware optimized for perfusion workflows with cutouts

for large connectors• Mixing times, power input per volume (PIV), and kL aperformance optimized for modern cell culture processes

DynaDrive S.U.B. (50 L) and HyPerforma G3LiteBioprocess Controller>100 million cells/mL• Improved seed train process—10:1 turndown ratio in the50 L reactor and 20:1 turndown in the 500 L unit
• Ergonomically friendly hardware—designed with the user inmind and allows for consistent and uniform BPC loading• Drive train integrated into the BPC—no external drive

shaft required• Enhanced drilled hole sparger (DHS) included for superiormass transfer performance

DynaDrive S.U.B. (500 L) and HyPerforma G3Lite
Bioprocess Controller

4

Continuous processing
developments and advancements
While it is estimated that less than 10% of approved biologic

Improvements in single-use systems allow the implementation

products in the market are currently manufactured throughof high-density cultures through continuous manufacturing inperfusion or continuous processing, this method of production

emerging workflows. While progressive advances in media

is gaining ground in its applicability for bioprocessing. Perfusion

optimization and improved clone genetic selection increasetechnology, the driving force for continuous manufacturing, wasstress on continuous single-use systems, strategic

first used in the 1980s for the manufacture of sensitive proteinsenhancements to the S.U.B. are integrated to counter thewhich, under traditional production, did not maintain theirperceived limitations. Coupled with best-in-class media hydration,

biological function. Later, users leveraged this method in thehold tanks, and bioreactor control systems, a continuous

production of blood clotting factors, antibodies, and enzymes.

bioprocessing workflow is established.

The promise of greater productivity, high quality, and increased
flexibility at more economical costs has renewed interest in
this technology.

Workflow explanation
A continuous processing workflow (Figure 1) allows cells toenhanced quality. Perfusion amplifies the benefits of single-use

grow to higher cell densities within the bioreactor, in contrast

technologies, enabling more efficient use of production space

to traditional batch or fed-batch processes. This is facilitatedand greater overall flexibility.

by the regular addition of fresh media and continuous removalof extracellular proteins and metabolic waste. Using perfusion,
significant yields (as measured in grams of protein per cell pervolume) are feasible at a smaller scale, meaning more productis produced in a reduced facility space. Due to the continuous
nature of the process, increased cell production can be achieved
over a shorter period of time. Regular replenishment of nutrients,
combined with reduced buildup of waste products in the S.U.B.,
allows for consistent homogeneity in the vessel and a higher
degree of control over culture conditions, which contribute toFigure 1. A continuous processing workflow.

6The resurgence in popularity of continuous manufacturing has
led to increased focus on technologies that support perfusion
as a complete workflow solution. With the appropriate
hardware in place, those who wish to accomplish continuous
manufacturing in the near future must augment their processwith accessory products from a variety of sources. Thus, theselection of consumable products that both deliver highperformance and connect seamlessly within your process
remains a crucial decision.

Our open-architecture approach
Our modular workflow system offers a complete selection ofAll Thermo Scientific™ BPC products are manufactured underconsumables configured specifically for continuous processes.

current good manufacturing practice (cGMP) conditions in

They provide the critical foundation for evolving your process to

ISO Class 7 clean areas to deliver high levels of quality andcontinuous, while leveraging our single-use mixers (S.U.M.s) andtraceability. Redundant manufacturing capabilities on a global

S.U.B.s. The Thermo Scientific Aegis 5-14 film platform provides

scale provide a strong assurance of product supply.

™

™

exceptional performance and flexibility, making it the ideal choicefor the demands of continuous manufacturing.

Our open-architecture approach delivers excellent options incustomer choice for design optimization and risk mitigation. MoreOur single-use products are configured with fit-for-purpose

than 20 years of application experience and product development

components sourced from approved partners. Each component

in single-use systems has given us the professional experienceis qualified to our rigorous requirements, which meet or exceed

to deliver innovative solutions and provide technical support

American Society of Mechanical Engineers-Bioprocessing

in a variety of ways. Our investment in capacity expansion,Equipment (ASME-BPE) standards of working pressure,automation, and particulate control demonstrates our strong

post-gamma stability, biocompatibility, cleanliness, andcommitment to excellence in manufacturing of consumables.

robustness. Our products are developed under the following test
methods to help ensure the highest level of performance:• International Organization for Standardization (ISO)• United States Pharmacopeia (USP)• European Pharmacopoeia (EP)• American Society for Testing and Materials (ASTM)

Permeatetransfer

Permeatepooling

Filtration(ATF, TFF)

Media
preparation

Sterile media
filtration andfluid transfer

Sterilemedia hold

Sterile fluid
transfer

Cell growth(bioreactor)
Cell bleed

Figure 2. Open-architecture workflow approach.

7

Ordering information
S.U.B. hardware and enhanced S.U.B. for perfusion BPCs
See the Bioproduction Product Offering brochure for all BPCs and hardware options, including S.U.B. vessels, mixers, bins, andperipherals. To support the perfusion workflow and the recommended consumables outlined below, the standard 5:1 S.U.B. hardware
is used as a basis for ordering, with recommended modifications including, where applicable, alternate motor mount, motor, and drive
shaft. Please work with your Thermo Fisher Scientific representative to tailor a system to your process needs for each vessel size.

HyPerforma S.U.B. hardware
Size

50 L

100 L

250 L

500 L

Description

Cat. No.

50 L S.U.B. jacketed, 5:1, 120 VAC, load cell

SUB0050.8100

50 L 2:1 drive shaft

SV50177.34

50 L S.U.B. BPC with ATF connection

SH31170.01

50 L S.U.B. BPC with TFF connection

SH31173.01

100 L S.U.B. jacketed, 5:1, 120 VAC, load cell

SUB0100.8200

100 L 2:1 drive shaft

SV50177.14

100 L S.U.B. BPC with ATF connection

SH31144.01

100 L S.U.B. BPC with TFF connection

SH31171.01

250 L S.U.B. jacketed, 5:1, 120 VAC, load cell

SUB0250.8300

250 L 2:1 oversized drive shaft

SV50959.09

250 L 2:1 oversized motor block

SV50957.36

500 L AC motor

SV50237.18

250 L S.U.B. BPC with ATF connection

SH31143.01

250 L S.U.B. BPC with TFF connection

SH31172.01

500 L S.U.B. jacketed, 5:1, 240 VAC, load cell

SUB0500.8400

500 L 2:1 drive shaft

SV50177.36

500 L S.U.B. BPC with ATF connection

SH31142.01

500 L S.U.B. BPC with TFF connection

SH31169.01

DynaDrive S.U.B.s and BPCs
Description
DynaDrive Single-Use Bioreactor, 120 V
DynaDrive Single-Use Bioreactor, 240 V
DynaDrive Bioprocess Container,with ATF port8Size

Cat. No.

50 L

DDB0050.1011

500 L

DDB0500.1011

50 L

DDB0050.1021

500 L

DDB0500.1021

50 L

SH31192.02

500 L

SH31193.02

50 L example workflow and ordering information for ATF or TFF
The following tables outline a sample workflow for a perfusion process using a 50 L S.U.B. operating at 40 L working volume, anda perfusion rate of two vessel volumes per day for 30 days. The workflow utilizes 1,000 L S.U.M.s as the main containers for media
formulation, sterile media hold, and permeate pooling. Substitutions can be made as desired to meet individual process needs using
alternative vessels such as Thermo Scientific™ imPULSE™ Single-Use Mixers (S.U.M.s), Thermo Scientific™ HyPerforma™ Smartainer™
BPCs, or Thermo Scientific plastic outer support containers; additionally, alternative vessel sizes are available. Work with yourThermo Fisher Scientific representative for 100 L, 250 L, and 500 L systems to tailor a system to your process.

Media preparation (ATF or TFF)
Item

Description

Qty

Cat. No.

Hardware1,000 L S.U.M., jacketed, 120 VAC

1SUM1000.9004

BPC

1,000 L S.U.M. BPC, powder-to-liquid

3SH30974.04

Sterile media filtration and fluid transfer (ATF or TFF)
Item

Description

Details

Qty

Cat. No.

Fluid transfer extension

12.7 mm (1/2 in.) ID x 3.2 mm (1/8 in.) wall,C-Flex™ 374 tubing

1m
Capped—for welders

3SH31083.01

Pump set

0.25 m (10 in.) C-Flex 374 tubing to 0.5 m (19.7 in.)
PharMed™ BPT tubing to 0.25 m (10 in.)
C-Flex 374 tubing

12.7 mm (1/2 in.) ID x
3.2 mm (1/8 in.) wall
Capped—for welders

3SH31101.01

Filter option

10 in. Opticap™ XL filter

NA3SH31159.21

Fluid transfer adaptor

9.5 mm (3/8 in.) ID x 3.2 mm (1/8 in.) wall to 12.7 mm(1/2 in.) ID x 3.2 mm (1/8 in.) wall,
C-Flex 374 tubing

2m
Capped—for welders

3SH31091.01

Fluid transfer extension

9.5 mm (3/8 in.) ID x 3.2 mm (1/8 in.) wall,
C-Flex 374 tubing

5m
Capped—for welders

3SH31082.03

Sterile media hold (ATF or TFF)
Item

Description

Qty

Cat. No.

Hardware1,000 L S.U.M., jacketed, 120 VAC

1SUM1000.9004

BPC

1,000 L S.U.M. BPC, liquid-to-liquid

1SH30982.04

9Sterile fluid transfer (ATF or TFF)
Item

Description

Details

Qty

Cat. No.

Fluid transfer adaptor

9.5 mm (3/8 in.) ID x 3.2 mm (1/8 in.) wall to
12.7 mm (1/2 in.) ID x 3.2 mm (1/8 in.) wall,C-Flex 374 tubing

2m
Capped—for welders

1SH31091.01

Fluid transfer adaptor

3.2 mm (1/8 in.) ID x 1.6 mm (1/16 in.) wall to 9.5 mm(3/8 in.) ID x 3.2 mm (1/8 in.) wall, C-Flex 374 tubing

2m
Capped—for welders

1SH31086.01

Fluid transfer extension

3.2 mm (1/8 in.) ID x 1.6 mm (1/16 in.) wall,
C-Flex 374 tubing

5m
Capped—for welders

1SH31079.03

Pump set

0.25 m (10 in.) C-Flex 374 tubing to 0.5 m (19.7 in.)
PharMed BPT tubing to 0.25 m (10 in.)
C-Flex 374 tubing

3.2 mm (1/8 in.) ID x
1.6 mm (1/16 in.) wall
Capped—for welders

1SH31097.01

Fluid transfer extension

3.2 mm (1/8 in.) ID x 1.6 mm (1/16 in.) wall,
C-Flex 374 tubing

5m
Capped—for welders

1SH31079.03

Bioreactor (ATF or TFF)Item

Description

Qty

Cat. No.

Hardware50 L S.U.B., jacketed, 120 VAC, analog load cell

1SUB0050.8100

BPC for ATF

50 L S.U.B. BPC, ATF-specific perfusion BPC

1SH31170.01

BPC for TFF

50 L S.U.B. BPC, TFF-specific perfusion BPC

1SH31173.01

S.U.B. BPC add-ons (ATF or TFF)
Item

Description

Qty

Cat. No.

Tubing assembly

Aseptic connector, connects to Thermo Scientific™ TruTorr™ single-usepressure sensor

1SH31134.02

Probe assembly

Bioreactor probe assembly with AseptiQuik™ connector—nonsterile(allows connecting conventional probes to S.U.B. BPC)

2SH30720.02

ATF-SU connections (for Repligen™ XCell ATF™ 6 technology only)
Item

Description

Qty

Cat. No.

Top permeate

Permeate connection for filter wetting and permeate connection

1SH31159.01

Bottom permeate

Plug for ATF permeate

1SH31159.05

Top retentate

ATF to BPC connection 1

1SH31159.02

Bioreactor

ATF to BPC connection 2

1

SH31159.03

Flush/drain port

Connection for filter wetting

1SH31159.04

Note: Work with TFF supplier for proper single-use connections from S.U.B. BPC to TFF.

10Permeate transfer (ATF or TFF)
Item

Description

Details

Qty

Cat. No.

Fluid transfer adaptor(ATF only)

3.2 mm (1/8 in.) ID x 1.6 mm (1/16 in.) wall to 9.52 mm(3/8 in.) ID x 3.2 mm (1/8 in.) wall, C-Flex 374 tubing

2m
Capped—for welders

1SH31086.01

Fluid transfer extension

3.2 mm (1/8 in.) ID x 1.6 mm (1/16 in.) wall,C-Flex 374 tubing

5m
Capped—for welders

1SH31079.03

Pump set

0.25 m (10 in.) C-Flex 374 tubing to 0.5 m (19.7 in.)
PharMed BPT tubing to 0.25 m (10 in.)
C-Flex 374 tubing

3.2 mm (1/8 in.) ID x
1.6 mm (1/16 in.) wall
Capped—for welders

1SH31097.01

Fluid transfer extension

3.2 mm (1/8 in.) ID x 1.6 mm (1/16 in.) wall,
C-Flex 374 tubing

5m
Capped—for welders

1SH31079.03

Fluid transfer adaptor

3.2 mm (1/8 in.) ID x 1.6 mm (1/16 in.) wall to
9.5 mm (3/8 in.) ID x 3.2 mm (1/8 in.) wall,
C-Flex 374 tubing

2m
Capped—for welders

1SH31086.01

Fluid transfer adaptor

9.5 mm (3/8 in.) ID x 3.2 mm (1/8 in.) wall to
12.7 mm (1/2 in.) ID x 3.2 mm (1/8 in.) wall,C-Flex 374 tubing

2m
Capped—for welders

1SH31091.01

Permeate pooling
Item

Description

Qty

Cat. No.

Hardware1,000 L S.U.M., jacketed, 120 VAC

1SUM1000.9004

BPC

1,000 L S.U.M. BPC, liquid-to-liquid

1SH30982.04

Cell bleed
Item

Description

Details

Qty

Cat. No.

Fluid transfer extension

3.2 mm (1/8 in.) ID x 1.6 mm (1/16 in.) wall,
C-Flex 374 tubing

5m
Capped—for welders

1SH31086.01

Pump set

0.25 m (10 in.) C-Flex 374 tubing to 0.5 m (19.7 in.)
PharMed BPT tubing to 0.25 m (10 in.)
C-Flex 374 tubing

3.2 mm (1/8 in.) ID x 1.6mm (1/16 in.) wall
Capped—for welders

1SH31079.03

Fluid transfer extension

3.2 mm (1/8 in.) ID x1.6 mm (1/16 in.) wall,C-Flex 374 tubing

5m
Capped—for welders

1SH31097.01

Fluid transfer adaptor

3.2 mm (1/8 in.) ID x 1.6 mm (1/16 in.) wall to 6.35 mm 2 m(1/4 in.) ID x 1.6 mm (1/16 in.) wall, C-Flex 374 tubing
Capped—for welders

1SH31084.01

Plastic drum

200 L Thermo Scientific™ conical LLDPE drum

1SV50517.10

BPC200 L BPC

1SH30967.03

1SV50029.03

Sterile liquid hold

Plastic drum dolly

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© 2019–2022 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its
subsidiaries unless otherwise specified. ALLpaQ is a trademark of ALLpaQ Packaging Limited. AseptiQuik is a trademark of Colder
Products Company. DeltaV is a trademark of Emerson Electric Co. Opticap is a trademark of Millipore Corporation. PharMed and C-Flex
are trademarks of Saint-Gobain Performance Plastics Corporation. XCell ATF is a trademark of Repligen Corporation.. EXT3998 1022