DATA SHEET

XDR Single-Use Bioreactors

Introduction
The XDR Single-Use Bioreactor is a fully-integrated system that deliv-

SYSTEM SNAPSHOT

ers proven stirred-tank performance across a wide range of cell lines.

u
Fully-integrated, turnkey GMP system

Single use technology eliminates time consuming and costly clean in

place (CIP), steam in place (SIP) and cleaning validation procedures. The
systems turnkey design enables fast installation and startup as well as
rapid batch-to-batch turnover and increased process flexibility compared to fixed stainless steel hard piped vessels.
The XDR is offered in five sizes (50, 200, 500, 1000, and 2000L) with
working volumes ranging from 10L to 2,000L. The systems unique de
sign enables each XDR to operate down to 20% of maximum working

u
Proven, scalable stirred tank performance
across a wide range of cell lines
u
Single-use design eliminates CIP/SIP
u
Operating volumes of 10L to 2,000L
u
Essential process instrumentation included
and fully characterized
u
Integrated temperature control and dimpled
vessel jacket for efficient heat transfer

volume (5:1 turn-down ratio), which can often eliminate the need for an

u
Powerful, user-friendly control system

additional seed reactor and related costs. Each reactor system includes

u
Predictive modeling and Xcellerex process
expertise eliminates start-up headaches and
ensures process efficiency

a stainless steel vessel, vital process instrumentation, state-of-the-art

control automation, and an optimized single-use bioreactor bag assembly. For high-density microbial applications, ask about the XDR-50 Turbo
model.

uEfficient, Convenient Vessel Design The vessel features a dimpled jacket heat
transfer surface for efficient heating and cooling, a high performance bottommounted magnetic drive agitator system that facilitates loading and coupling of
the single-use bag assembly, load cells for weight measurement, an exhaust filter
heater box, flexible hoses for the heat transfer fluid, and a tubing manager.
uCritical Process Instrumentation Mass flow controllers,
peristaltic pumps, and probe transmitters are built into the
cabinet adjacent to the vessel, and an external temperature
control unit is available as an option for process heating/cooling. The system requires only gases, power and minimal water
for full functionality.
XDR 2000 u

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uPowerful, User-Friendly Controls The XDR is

agitator includes a HDPE bottom mounted impeller and a

equipped with a fully integrated control console,

unique sparge system consisting of microporous stainless

featuring intuitive process controls,

steel disks and optional drilled holes that together impart

data historian, and robust automa-

the system with tremendous flexibility crucial for todays cell

tion hardware/software. The system

culture processes. Xcellerex also maintains multiple supply

enables precise process control,

and offers convenient real-time

sources to guard against supply chain disruptions.

Expert process support from Xcellerex With years

trending and other valuable data.

of experience running and supporting GMP biomanufactur-

When coupled with Xcellerexs

ing operations, Xcellerex designed the XDR system to deliver

process development experience

complete process control from the moment each system

and predictive modeling support,

the XDR control platform assures optimized first-run

starts up. No other single-use bioreactor is available with the

XDRs depth of characterization, process support, and GMP-

process performance and reliability through tech

readiness. Xcellerex is uniquely able to deliver critical control

transfer and scale-up.

automation with instrumentation, functionality, process modeling, tech transfer, and scalability.

uRobust Single-Use Components The XDR irradiated

single-use bag assembly consists of a USP Class VI LDPE
fluid contact layer, tubings for liquid additions and harvest,
sampling and probe ports, a disposable pressure sensor,
filtered gas lines, and high-functioning agitator system. The

Key XDR Advantages

u 5:1 turndown means each XDR can operate at 20% of maximum working
volume, doing the work of multiple reactors

u XDR Single Use Reactor Systems are Factory Acceptance Tested (FAT) prior
to delivery and Site Acceptance Tested (SAT) upon installation

u True plug-and-play performance: Connect gases and power and get

started

u Each XDR Single Use Reactor System is shipped with a Turnover Package
which includes XDR Operating Manual, System Specifications, FAT
commissioning report, system drawings, component operating manuals,
calibration records, and optional IQ/OQ protocols

u Robust, self-installing magnetically-driven bottom-mount impeller:

No rotating seals, insertable shafts and connection hassles
u Jacketed vessel ensures uniform temperature distribution throughout
reactor

u Xcellerex process experience and know how is built into every XDR
System: our process development expertise ensures that the process is
up and running right the first time

u Flexible control systems automate temperature shifts, feeds, changes to

sparge composition

u Xcellerex offers extensive XDR-specific predictive modeling and expert

scale-up support

u Multiple probe configurations available, including pH, DO, CO2, and

biomass

u Enhanced sparge control and CO2 stripping capabilities not offered on

other single use systems

u Accurate gas control using mass flow controllers on all systems (optional
MFC for headspace on XDR50)

u Designed and fully characterized to deliver scalable cGMP processes from

10L to 2000L

u Bag material sourced from multiple manufacturers for supply chain security

u Xcellerex has years of cGMP manufacturing experience operating the XDR

system. GMP product made in the XDR is currently being used in clinical
trials and commercial XDR facilities are currently being prepared for commissioning.

u Single-use design eliminates time consuming CIP, SIP and cleaning validations procedures

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SYSTEM SPECIFICATIONS
XDR-50

XDR-200

XDR-500

XDR-1000

XDR-2000

50

200

500

1000

2000

BIOREACTOR
Max Working Volume (L)
Min Working Volume (L)

10

40

100

200

400

Volume turn-down ratio

5:1

5:1

5:1

5:1

5:1

Tank ID (in)

12

22

30

38

48

Liquid height, max Vw (in)

30

33.5

45.6

56.7

70.9

H/D

2.5

1.5

1.5

1.5

1.5

Vessel Material of Construction

Jacketed 304 SS

Jacketed 304 SS

Jacketed 304 SS

Jacketed 304 SS

Jacketed 304 SS

Filter Heater Box

Bag Hoist

NA

NA

NA

Automated

Automated

Agitation
Motor

Servo
Lift/Position:
Lowered/raised to center

Impeller

Lift/Position:
Lowered/raised to 15 off-center
Bottom mounted, magnetically-driven, single-use impeller integrated with bag assembly

Impeller type

M40E

No. of impellers, blades

1,3

1,3

1,3

1,3

1,4

Impeller diameter (in)

10

12

16

0.67

0.36

0.33

0.33

0.33

Center 90

15 off center

15 off center

15 off center

15 off center

Stanless steel sintered disks

Stanless steel sintered disks

Stanless steel sintered disks

Stanless steel sintered disks

Stanless steel sintered disks

Drilled Hole

Drilled Hole

Drilled Hole

Drilled Hole

Drilled Hole

CO2 stripping

CO2 stripping

CO2 stripping

CO2 stripping

CO2 stripping

pH probes

DO probes

Rotometer-01

n/a

n/a

n/a

n/a

Standard

Additional (optional)

Di/Dt
No. of baffles
Impeller location
Standard
Sparger

Optional

PROCESS INSTRUMENTATION

MFCs (Brooks)
Pumps
Temperature Control Unit

Load Cells

2 Pumps are standard. Additional pumps are available as an option

Optional: 3 kw heater

Optional: 9 kw heater

Optional: 3 kw heater/
0.5 ton chiller combo

Optional: 9 kw heater/ 1.5 ton chiller combo

Utility Requirements

Process gases / 110V, single phase, 60 hz / TCU: 230V, 3 phase, 60 hz (EU: 380V, 3 phase, 50 hz)

E-Stop

Integrated Safety Circuit for pumps, agitator, TCU, and filter heater

CONTROL UNIT (see page 5 for additional detail)

Integrated Control Panel
Hardware
Operator Interface

Built to GAMP5 standards

Optional: 21 CFR Part 11 Compliant

Built to GAMP5 standards/ 21 CFR Part 11 Compliant

Rockwell/ Allen Bradley
Wonderware HMI

(Optional: Delta-V)
(Optional: Delta-V)

Data Historian

Wonderware (Optional: Delta-V)

Programming

Rockwell Allen Bradley/Wonderware Archestra (Optional: Delta-V)

NOTE: This document describes standard systems and commonly requested options. Additional custom-engineered systems are also available to meet unique application needs. Ask your Xcellerex representative for details.

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PERFORMANCE CONTROL SPECIFICATIONS

XDR-50

pH

DO

XDR-200

XDR-500

Range

2-12 pH units

Accuracy

0.05 pH units

Range

*Additional MFC/sparge
ranges can be supplied
based on application
requirements
Temperature

Bag Pressure

XDR-2000

0-100% atmospheric saturation

Accuracy
Sparge Rate (slpm)

XDR-1000

1.0% of setpoint

Air*

0-5

0-5

0-10

0-10

0-10

02*

0-5

0-5

0-10

0-10

0-10

C02*

0-5

0-5

0-10

0-10

0-10

Air Headsweep*

0-10

0-10

0-20

0-20

0-20

0-140

0-115

Range

4-60 C

Accuracy

0.2 C

Range

0 - 30 psig (0 - 2068 mbar)

Accuracy
Agitation (rpm)

0.1 psig ( 6.89 mbar)

0-400

0-350

0-250

Load Cell Accuracy

0.2% of max bag volume

Process OUR (mmol/L/h)

Up to 10.0, covers all cell culture applications

kLa (1/h)

Up to 25, covers all cell culture applications

NOTE: For high-density microbial applications, please ask about the XDR-50 Turbo system.

SPACE REQUIREMENTs
XDR-50

XDR-200

XDR-500

XDR-1000

XDR-2000

Width (Vessel & Control Unit)

4 ft.
(1.22M)

6 ft.
(1.83M)

10 ft.
(3.05M)

17 ft.*
(5.18M)

18 ft.*
(5.49M)

Depth (Vessel & Control Unit)

3.5 ft.
(1.07M)

5 ft.
(1.52M)

5 ft.
(1.52M)

5 ft.
(1.52M)

5 ft.
(1.52M)

Height (Vessel & Control Unit)

7.5 ft.
(2.29M)

9 ft.
(2.74M)

10 ft.
(3.05M)

12 ft.
(3.67M)

14 ft.
(4.27M)

* Includes portable ladder for access to top of vessel

Fully-Integrated XDR Bioreactor bag Assembly

USP Class VI
LDPE fluid contact layer
Gamma Irradiated
Validation Guide (available upon request)

Standard off-the-shelf designs impart flexibility for a wide range of

cell culture and microbial processes.
Custom application-specific designs available upon request.

Each bag comes complete with:

C-flex tubing (for tube-to-tube aseptic welding)

Aseptic connectors
Multiple feed/addition lines
Harvest line
Exhaust filter
Sparge filter
Overlay filter
Pressure sensor
Sampling ports
Probe ports
Thermowell (for temperature probe)
Proprietary XDR impeller/sparge system

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CONTROL AUTOMATION PLATFORM

The XDR Control Platform is comprised of a Rockwell/Allen Bradley controller with Wonderware HMI
and data historian. The platform delivers precise process control and offers a level of flexibility and
convenience that is unmatched in the industry.
In addition to robust control architecture, the XDR features a highly intuitive user interface that speeds
operator training and efficiency.

uIntuitive, Powerful Interface

The XDR control system user interface was designed to provide fast and easy, yet comprehensive
control over process configuration to the operator. The easy-to-read screens enable dynamic adjustment to key variables, and enable the operator to review complete configuration schemes at a glance.
The high clarity touchscreen display provides an intuitive, visual interface that operators can use with
confidence. (See Screen 1)

Screen 1 - System Overview

The XDR system enables rapid understanding and interpretation of active control strategies through
the use of graphical symbols. (See Screen 2)
In addition, set-point automation tables enable the easy automation of set-point changes, permitting
live adjustments to ramp or step to new value. (See Screen 3)

uPowerful Control Strategies for Fast Response, Tight Control

Cascade control strategies of pH, DO, and volume result in very tight control of critical process
conditions.

Flexible closed loop control of critical process parameters support improved yields:

Agitation
Gas mixing
Liquid addition and removal
pH
Weight

Dynamic reconfiguring of cascade control loops enables exceptional process flexibility.

Screen 2 - Cascade Loop Control

Sparge
Gas overlay
Temperature
DO (See Screen 4)

Screen 3 -Set Point Automation Tables

uComprehensive, Real-Time Data Capture, Reporting and Trending

The real-time data historian captures all process parameters and times, and offers
accessible look-up.

Export of data to other master data repository systems is supported with built-in functionality

Real time alarming protects process integrity and helps avoid lost batches

All alarms are logged to database

Screen 4 - DO Strategy Set-Up Screen

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XDR PERFORMANCE DATA

CHO Process -Titer Data

Figures 1-3 illustrate examples of first-run data

for a series of CHO processes, demonstrating the
XDR systems ability to achieve immediate process
equivalence. Additional, extensive data is available
on request.

XDR
10LGlass
glassReactor)
reactor
Figure 1: CHO Process - Titer Data (XDR
vs.vs10L
120
XDR-1000

100

XDR-200
XDR-200

Titer (ug/mL)

80

10L glass
10L glass

60

40

20

FIGURE 1: XDR achieved equivalent or better titer

during scale-up from a 10 liter glass reactor to a
200 L XDR to a 1000 liter XDR.

0
0

10

Day

CHOvs.
Process
Figure 2: CHO Process - Viability Data
(XDR
10L Glass Reactor)
XDR vs 10L glass reactor

14

100

XDR-1000
10

80

XDR-200
XDR-200

60

10L glass
10L glass

40

Percent Viable Cells

Viable cells (e6 cells/mL)

12

4
20
2

FIGURE 2: XDR achieved equivalent or better cell

viability during scale-up from a 10 liter glass reactor to a 200L XDR to a 1000 liter XDR.

0
0

10

Day

CHO-Perfuson
Culture
Data Reactor)
Figure 3: CHO Perfusion Process
ViabilityProcess-Cell
Data (XDR vs.
10L Glass
100

FIGURE 3: XDR achieved process equivalence for

a perfusion process at the 200L and 1000L scale.

90

12

80
XDR-1000

70

10L glass

60

XDR-200

50

10
8
6

40
30

20
2

10

0
0

10

15
Day

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20

Percent Viable Cells

Viable Cell Density (e6 cells/mL)

14

ABOUT XcellereX

Xcellerex offers a unique blend of bioprocess systems, platform technology, and services delivered by a team with deep
roots as biomanufacturing practitioners.

Single-Use Bioreactors & Mixers

FlexFactory Platform

Xcellerex single-use GMP bioreactors systems

outperform other disposables-based systems and
traditional stainless steel systems on the first run and
every run. Unlike other bioreactors, Xcellerex systems are
fully integrated, including a vessel, control unit and the
knowledge base that comes with the Xcellerex process
development and production teams.

FlexFactory is a portable, modular, all-disposables

bioproduction train that eliminates conventional clean
room requirements and delivers new production capacity
in less than 1 year vs. 3-5 years; 50%-70% less capital
investment; 50% lower operating costs; and multi-drug
production with simple modifications to
modular components.

Co-Developed &
Proprietary Molecules

Process Development &

GMP Manufacturing Services

Xcellerex is so passionate about the power of our

technology that we are working with partners to develop a
portfolio of proprietary molecules enabled by the Xcellerex
platform. Sourced primarily through in-licensing, these
programs enable Xcellerex to demonstrate our conviction
in the FlexFactory model while also continuously
enhancing our technology and expanding our
knowledge base for the benefit of customers
and partners.

To help clients eliminate many of the risks involved with

deploying new bioprocessing capacity, Xcellerex offers a
world-class suite of technical services. PDMax
Process Development services ensure you get an optimized
process fast. Xcellerex GMP biomanufacturing services
allow instant access to FlexFactory capacity for
evaluation purposes or as a bridge until your own
FlexFactory operation is ready for launch.

FOR ADDITIONAL INFORMATION

To learn more about XDR Single-Use Bioreactors or other Xcellerex systems or services,
please contact customer service at:
Toll Free:

1-866-Xcellerex (1-866-923-5537)

Telephone:

1-508-480-9235

Email:

[email protected]

TM

Xcellerex, Inc.
170 Locke Drive
Marlborough, MA 01752
USA

Toll Free: 1-866-Xcellerex

Tel: 508-480-9235
[email protected]
www.xcellerex.com
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