Xpansion Multiplate Bioreactor System Multiplate bioreactor for cell-based product manufacturing

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USD2939 (1)

Xpansion

®

Multiplate Bioreactor System

Multiplate bioreactor for cell-based product manufacturing

Features and Benefits

USP Class VI certified materials

Designed for adherent cell culture applications

Single-use closed bioreactor, from vessel to sensors, reduces risk of contamination

2-D multiplate design allows easy adaptation from traditional multitray systems

Real-time control and monitoring ensures reproducibility and traceability

Reduced operations results in process simplification, flexibility, and assurance

The Xpansion multiplate bioreactor is part of the Pall Life Sciences’ single-use bioreactor family, designed for shear-sensitive adherent cell applications, such as cultivation of stem cells.

The Xpansion multiplate bioreactor was developed for safe, large-scale production of traditional 2-D cell cultures. The multiplate structure is comprised of a large cell growth surface area (up to 122,400 cm 2 ), while the compact design enables the elimination of the gas phase between the plates. This gas phase is replaced by an automatically controlled aeration system which provides advanced gas diffusion. Control is automatic via disposable pH and dissolved oxygen (DO) sensors. Temperature monitoring and agitation control are also included. Xpansion bioreactors offer the capability of monitoring cell morphology and density through the use of an optional digital holographic microscope.

Xpansion System Components

The Xpansion system includes a single-use bioreactor, docking station and a controller.

Single-Use Bioreactor with Stacked Multiplate Design

Comprised of stacked hydrophilized polystyrene radial plates, the Xpansion bioreactor is designed to promote cell growth on the top of each plate; each plate has a hole in the center. The stacking of these plates forms the central column which allows circulation of the medium in the bioreactor and gas exchange.

The plates are covered by an outer tube, a head plate on the top and a base plate on the bottom. On the head plate, there are:

Six sensor connectors: pH, DO, and four optional sensors

Three viewing windows for use with optional holographic microscope

Two vent filters

Two gas filters (in and out) for aeration system

One thermowell port

One sampling port

In the bottom side of the bioreactor, there are:

Two fluid operation ports (e.g., inoculation, harvest, etc.)

One magnetic impeller

13

2

1

3

10

9

2

1

4

5

6

7

8

13

11

12

The Xpansion Multiplate Bioreactor

Materials

1

2

Gas lines

(in & out)

Vent.1

C-Flex ◆ tubing and silicone 3/16 in. ID, 0.2 μm hydrophobic filters (PTFE, polyester, polypropylene)

C-Flex 3/16 in. ID, 2 0.2 μm hydrophobic filters (PTFE, polyester, polypropylene)

3 Sampling port C-Flex 3/16 in. ID with needleless connector for sampling with luer syringe + oneway valve

4 Top part Clear polystyrene

5 Cell surface plates

6 Aeration support

Cell culture plasma-treated clear polystyrene

Polypropylene + polycarbonate

7 Aeration tubing Silicone 0.58 in. ID x 0.77 in. OD

8 Outer tube

9 Stirrer cover

10 Impeller

Polyvinyl chloride

Clear polystyrene

Ultra-high-molecular-weight polyethylene

11 Bearing

12 Bottom part

Polyether ether ketone

Clear polystyrene

13 Liquid in/out tubing

C-Flex Clear 374 Tubing 3/8 in. ID, CPC connector, 0.2 μm hydrophobic filters

Sealing material Resin

◆ MPC male

An Xpansion Plate

Docking Station

The bioreactor docks to a station that includes a magnetic drive stirring unit powering the magnetic impeller.

Control of agitation speed is integrated in the controller. The setpoint is defined via the screen on the front side of the controller.

Controller

The controller has measurement/control hardware and a gassing system with a digital control.

Features of the Xpansion controller include:

Graphic user interface with color display and touch screen operation with Administrator and Operator security levels

Integrated transmitters for temperature, disposable DO and pH sensors

Integrated control loops for DO and pH

Agitation control (speed range from 5 to 250 rpm)

Temperature monitoring

DO and pH sensor patches arrive precalibrated; data are transferred via a USB key to the controller

In-process DO and pH can be recalibrated

Trend display for up to four process values (pH, DO, T, gas flow rate)

Controller Gas Module

The controller is connected to the user’s gas supply line. Its “gas outlet” is connected to the “gas in” filter of the bioreactor. Gas composition to be injected in the bioreactor is regulated by controller solenoid gas valves. The flow rate of the mixed gas is adjusted by a massflow controller (0-200 mL/min). The controller gas module contains:

One gas diffuser outlet

Four solenoid valves of Air, N

2

, O

2

, and CO

2

One Mass Flow Controller for mixed gas flow control

Data Management

The Xpansion system has one ethernet port for data communication/ acquisition. It can be linked to egraph (optional software and computer provided by Pall Life Sciences). egraph is installed on a host PC and provides data acquisition for all process values.

Xpansion Controller and Docking Station

Controller

Height

Depth

Width

Weight

Power supply

Interface

Stirrer speed

Integrated measurement module

One point recalibration function

Gas options

Temperature monitoring

50 cm (19.7 in.)

40 cm (15.7 in.)

25 cm (9.8 in.)

15 kg (33 lbs.)

100 – 240 VAC, 50 – 60 Hz

Ethernet

USB host

5 – 250 rpm

Disposable DO sensor

Disposable pH sensor

Temperature

Disposable DO sensor

Disposable pH sensor

O

2

N

2

CO

2

Air

0 – 50 ºC (32 – 122 ºF)

Gas Requirements

Gases

Air

CO

2

Oxygen

Application Specification pH control Compressed air – medical grade

Outlet pressure between 1 and 2 bars

(14.5 – 30 PSI) 6 mm Festo connectors pH control

DO control

Pure CO

2

Outlet pressure equivalent to air pressure

6 mm Festo connectors

Medical grade oxygen

Outlet pressure equivalent to air pressure

6 mm Festo connectors

Nitrogen DO control

(optional)

Medical grade nitrogen

Outlet pressure equivalent to air pressure

6 mm Festo connectors

www.pall.com/cellculture

3

Performance

Standard Cell Environment Preservation

As in multitray stacks, cells adhere and grow on hydrophilized polystyrene plates and are harvested using a cell dissociation reagent.

Because of its specific design, the system maintains the same environment as T-flasks or multitray stacks, and enables implementation of a process easily-adapted from these traditional methods.

Cell Culture Parameters (pH, DO) Control and

Temperature Monitoring

The Xpansion head plate includes patch ports for optical non-invasive measurement of pH and DO. For contamination risk elimination, the determination of pH and DO is based upon the principle of fluorescence. Depending on the DO and pH measurement, gas regulation is activated via the controller according to users’ requirements.

Temperature is measured for monitoring via a PT100 reusable sensor installed in a thermowell of the bioreactor. The heating is done via an incubator or in a warm room.

Each measure (pH, DO and T) is associated with an alarm.

Aeration System

Gas aeration occurs depending on pH and DO control limits set by the users. Gas composition control depends on pH and

DO measurement in the bioreactor. The gas coming from the controller enters via the “gas in” filter of the bioreactor and passes through very thin silicone tubing placed in the central column. The gas inlet and outlet include pre- installed hydrophobic aeration filters. Gases diffuse through the tubing.

Homogenization by Medium Circulation

Medium circulation is coupled with the aeration system which depends on pH and DO control. The medium can also circulate in the bioreactor independent of gas aeration according to users’ requirements. Each plate contains 16 radial channels supporting media flow rate. The rotation of the impeller pushes the liquid upward, first vertically through the first plate channel, then horizontally over the plate, then up again to the second plate, etc.

Cell Morphology and Density Monitoring

Cell density and morphology are monitored via a specialized holographic microscope developed by Ovizio Imaging Systems

NV and available through collaboration with Pall Life Sciences.

This technology provides a platform to observe cells on multiple layers with high image quality.

Optical pH Sensor Performance Specifications

Detection range

Accuracy

Precision

Response time (t90 )

Calibration

Materials pH 6.0 – 9.0

±0.1 @ pH 6.5 – 7.5

±0.01 @ pH 7.0

30 seconds

Shipped pre-calibrated, (calibration files on

USB key provided with the reactor). One point calibration required.

USP Class VI certified

Optical DO Sensor Performance Specifications

Detection range

Accuracy

Precision

Response time (t90 )

Calibration

Materials

0 - 150% air saturation

+/- 3.5% @ DO 15 - 75% air saturation

+/- 1.5% @ DO 15 - 100% air saturation

< 15 seconds

Shipped pre-calibrated, (calibration files on

USB key provided with the reactor). One point calibration required.

USP Class VI certified

The Xpansion Bioreactor Aeration System

Circulation of Culture Medium throughout the Xpansion

Bioreactor Plates

4

Technical Specifications

Bioreactors Xpansion MPB 10 Xpansion MPB 50

Number of plates

Cell culture surface

Media volume / surface area ratio

Bioreactor volume

10

6,120 cm 2 (949 in.

2 )

0.26 mL/cm 2

Central column volume

Overall weight

1.6 L

26 mL

2.5 kg (5.6 lbs.)

Overall height 29 cm (11.4 in.)

Minimum space requirement 49 cm x 48 cm x 40 cm for the bioreactor and docking station (H x W x D)

(19 in. x 19 in. x 16 in.)

Plate surface 612 cm 2 (94.9 in.

2 )

Plate thickness 0.1 cm (0.04 in.)

Distance between each plate 0.16 cm (0.06 in.)

Volume between each plate 98 mL

Head space volume 50 mL

Sterilization Gamma-irradiated to > 25 kGy

50

30,600 cm 2 (4,743 in.

2 )

0.18 mL/cm 2

5.6 L

132 mL

6.9 kg (15.2 lbs.)

47 cm (18.5 in.)

67 cm x 48 cm x 40 cm

(26 in. x 19 in. x 16 in.)

Xpansion MPB 100

100

61,200 cm 2 (9,486 in.

2 )

0.18 mL/cm 2

11.2 L

263 mL

12.5 kg (27.5 lbs.)

55 cm (21.6 in.)

75 cm x 48 cm x 40 cm

(30 in. x 19 in. x 16 in.)

Xpansion MPB 200

200

122,400 cm 2 (18,972 in.

2 )

0.18 mL/cm 2

21.9 L

527 mL

23.4 kg (50.7 lbs.)

81 cm (31.9 in.)

99 cm x 48 cm x 40 cm

(39 in. x 19 in. x 16 in.)

Ordering Information

Category

Hardware

Consumables

Material

Skid

Docking station

Harvest station

D3HM microscope*

Lift* eGraph computer*

Bioreactor

Seeding manifold*

Pooling manifold*

* Optional equipment and consumables

Description

1 controller, 2 optical fibers for pH and DO, 1 temperature probe (PT-100),

1 driver (magnetic stirring plate), 5 M of Festo gas tubing

Bioreactor support for inside incubator

Mechanical cell detachment device for harvest

Holographic; for observation of up to top 10 plates of the system

Ref #

810062 (EU)

810063 (US)

820369

810345SU

Safe movement of bioreactor from package to incubator and during observation under microscope (highly recommended for XP-100 and 200)

Process data recording (pH, DO, temperature and events); 1 computer can be used with up to 10 controllers

XP-10: 10-plate bioreactor

XP-50: 50-plate bioreactor

XP-100: 100-plate bioreactor

XP-200: 200-plate bioreactor

810265 (EU)

810260 (US)

810076 (EU)

810077 (US)

810072

810123

810122

810154

810155

2 L bottle with female MPC ◆ connector used to transfer cell suspension into seeding container. 6100097S

Note: for XP-10 the manifold can be directly connected to the bioreactor; for XP-50,

XP-100 and XP-200, intermediate container must be used.

Sterile 10 L bottle with female MPC connector used for pooling reagent bottles (cell culture medium, PBS, Trypsine, ...) and transfer into Pall 2D BPV bag

6100129

Corporate Headquarters

Port Washington, NY, USA

+1.800.717.7255 toll free (USA)

+1.516.484.5400 phone biopharm@pall.com e-mail

European Headquarters

Fribourg, Switzerland

+41 (0)26 350 53 00 phone

LifeSciences.EU@pall.com e-mail

Asia-Pacific Headquarters

Singapore

+65 6389 6500 phone sgcustomerservice@pall.com e-mail

Visit us on the Web at www.pall.com/bioreactors

E-mail us at bioreactors@pall.com

International Offices

Pall Corporation has offices and plants throughout the world in: Argentina, Australia, Austria,

Belgium, Brazil, Canada, China, France, Germany, India, Indonesia, Ireland, Italy, Japan,

Korea, Malaysia, New Zealand, Norway, Philippines, Poland, Russia, Singapore, South

Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, and Vietnam.

Distributors in all major industrial areas of the world. To locate the Pall office or distributor nearest you, visit www.pall.com/contact.

The information provided in this literature was reviewed for accuracy at the time of publication.

Product data may be subject to change without notice. For current information consult your local Pall distributor or contact Pall directly.

© 2015, Pall Corporation. Pall, , and Xpansion are trademarks of Pall Corporation. ® indicates a trademark registered in the USA and TM indicates a common law trademark. Filtration. Separation. Solution.

is a service mark of Pall Corporation. ◆ CPC and MPC are trademarks of Colder Products Company; C-Flex is a trademark of Cole-Palmer

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