XDR Datasheet

8
XDR Single-Use Bioreactors DATA SHEET www.xcellerex.com  1-866-Xcellerex Introduction  The XDR Single-Use Bioreacto r is a fully-integrated system that deliv- ers proven stirred-tank performance across a wide range of cell l ines. Single use technology eliminates time consuming and costly clean in place (CIP), steam in pl ace (SIP) and cleaning validation procedures . The system’ s turnkey design enables fast installation and startup as well as rapid batch-to-batch turnover and increased process exibility com- pared to xed stainless steel hard piped vessels.  The XDR is oer ed in ve sizes (50, 200, 5 00, 1000, and 2000L) with working volumes ranging from 10L to 2,000L. The system’ s unique de - sign enables each XDR to operate down to 20% of maximum working volume (5:1 turn-down ratio), which can often eliminate the need for an additional seed reactor and related costs. Each reactor system includes a stainless steel vessel, vital process instrumentation, state-of-the-art control automation, and an optimized single-use bioreactor bag assem- bly. For high-density microbial applications, ask about the XDR-50 Turbo SYSTEM SNAPSHOT u Fully-integrated, turnkey GMP system 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 ecient heat transfer u Powerful , user-friendly control system u Predictive modeling and Xcellerex process expertise eliminates start-up headaches and ensures process eciency model. uEcient, Convenien t Vessel Design  The vessel featur es a dimpled jacket heat transfer surface for ecient heating and cooling, a high per formance bottom- mounted magnetic drive agitator system that facilitates loading and coupling of the single-use bag assembly, load cells for weight measurement, an exhaust lter heater box, exible hoses for the heat transfer uid, and a tubing manager . uCritical Process Instrumentation Mass ow 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/cool- ing. The system requires only gases, power and minimal water for full functionality.  XDR 2000 u

description

XDR Datasheet

Transcript of XDR Datasheet

Page 1: XDR Datasheet

7182019 XDR Datasheet

httpslidepdfcomreaderfullxdr-datasheet 17

XDR Single-Use Bioreactors

DATA SHEET

wwwxcellerexcombull 1-866-Xcellerex

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

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

Single use technology eliminates time consuming and costly clean in

place (CIP) steam in place (SIP) and cleaning validation procedures The

systemrsquos turnkey design enables fast installation and startup as well as

rapid batch-to-batch turnover and increased process flexibility com-

pared 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 2000L The systemrsquos unique de-

sign enables each XDR to operate down to 20 of maximum working

volume (51 turn-down ratio) which can often eliminate the need for an

additional seed reactor and related costs Each reactor system includes

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

control automation and an optimized single-use bioreactor bag assem-

bly For high-density microbial applications ask about the XDR-50 Turbo

SYSTEM SNAPSHOT

u Fully-integrated turnkey GMP system

u Proven scalable stirred tank performanceacross a wide range of cell lines

u Single-use design eliminates CIPSIP

u Operating volumes of 10L to 2000L

u Essential process instrumentation included

and fully characterized

u Integrated temperature control and dimpledvessel jacket for efficient heat transfer

u Powerful user-friendly control system

u Predictive modeling and Xcellerex processexpertise eliminates start-up headaches andensures process efficiency

model

uEfficient Convenient Vessel Design The vessel features a dimpled jacket heat

transfer surface for efficient heating and cooling a high performance bottom-

mounted 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 heatingcool-

ing The system requires only gases power and minimal water

for full functionality

XDR 2000u

7182019 XDR Datasheet

httpslidepdfcomreaderfullxdr-datasheet 27

agitator includes a HDPE bottom mounted impeller and a

unique sparge system consisting of microporous stainless

steel disks and optional drilled holes that together impart

the system with tremendous flexibility crucial for todayrsquos cell

culture processes Xcellerex also maintains multiple supply

sources to guard against supply chain disruptions

Expert process support from Xcellerex With years

of experience running and supporting GMP biomanufactur-

ing operations Xcellerex designed the XDR system to deliver

complete process control from the moment each system

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

XDRrsquos depth of characterization process support and GMP-

readiness Xcellerex is uniquely able to deliver critical control

automation with instrumentation functionality process mod

eling tech transfer and scalability

Key XDR Advantages

u 51 turndown means each XDR can operate at 20 of maximum workingvolume doing the work of multiple reactors

u True plug-and-play performance Connect gases and power and getstarted

u Robust self-installing magnetically-driven bottom-mount impellerNo rotating seals insertable shafts and connection hassles

u Jacketed vessel ensures uniform temperature distribution throughoutreactor

u Flexible control systems automate temperature shifts feeds changes tosparge composition

u Multiple probe configurations available including pH DO CO2 andbiomass

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

u Bag material sourced from multiple manufacturers for supply chain security

u Single-use design eliminates time consuming CIP SIP and cleaning valida-tions procedures

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

u Each XDR Single Use Reactor System is shipped with a Turnover Packagewhich includes XDR Operating Manual System S pecifications FATcommissioning report system drawings component operating manualscalibration records and optional IQOQ protocols

u Xcellerex process experience and know how is built into every XDRSystem our process development expertise ensures that the process isup and running right the first time

u Xcellerex offers extensive XDR-specific predictive modeling and expertscale-up support

u Enhanced sparge control and CO2 stripping capabilities not offered onother single use systems

u Designed and fully characterized to deliver scalable cGMP processes from10L to 2000L

u Xcellerex has years of cGMP manufacturing experience operating the XDRsystem GMP product made in the XDR is currently being used in clinicaltrials and commercial XDR facilities are currently being prepared for com-missioning

wwwxcellerexcom bull 1-866-Xcellerex

uPowerful User-Friendly Controls The XDR is

equipped with a fully integrated control console

featuring intuitive process controls

data historian and robust automa-

tion hardwaresoftware The system

enables precise process control

and offers convenient real-timetrending and other valuable data

When coupled with Xcellerexrsquos

process development experience

and predictive modeling support

the XDR control platform assures optimized first-run

process performance and reliability through tech

transfer and scale-up

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

7182019 XDR Datasheet

httpslidepdfcomreaderfullxdr-datasheet 37

SYSTEM SPECIFICATIONS

XDR-50 XDR-200 XDR-500 XDR-1000 XDR-2000

BIOREACTOR

Max Working Volume (L) 50 200 500 1000 2000

Min Working Volume (L) 10 40 100 200 400

Volume turn-down ratio 51 51 51 51 51

Tank ID (in) 12 22 30 38 48

Liquid height max Vw (in) 30 335 456 567 709

HD 25 15 15 15 15

Vessel Material of Construction Jacketed 304 SS Jacketed 304 SS Jacketed 304 SS Jacketed 304 SS Jacketed 304 SS

Filter Heater Box 1 1 1 1 1

Bag Hoist NA NA NA Automated Automated

Agitation

Motor Servo

LiftPositionLoweredraised to center

LiftPositionLoweredraised to 15⁰ off-center

Impeller Bottom mounted magnetically-driven single-use impeller integrated with bag assembly

Impeller type M40ENo of impellers blades 13 13 13 13 14

Impeller diameter (in) 8 8 10 12 16

DiDt 067 036 033 033 033

No of baffles 0 0 0 0 0

Impeller location Center 90⁰ 15⁰ off center 15⁰ off center 15⁰ off center 15⁰ off center

Sparger

S ta nd ar d S ta nl es s s te el s in te re d d is ks S ta nl es s s te el s in te re d d is ks S ta nl es s s te el s in te re d d is ks S ta nl es s s te el s in te re d d is ks S ta nl es s s te el s in te re d d is ks

OptionalDrilled Hole Drilled Hole Drilled Hole Drilled Hole Drilled Hole

CO2 stripping CO2 stripping CO2 stripping CO2 stripping CO2 stripping

PROCESS INSTRUMENTATION

pH probes 1 2 2 2 2

DO probes 1 2 2 2 2

Rotometer-01 1 na na na na

MFCs (Brooks)Standard 3 4 4 4 4

Additional (optional) 3 2 2 2 2

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

Temperature Control Unit Optional 3 kw heater Optional 9 kw heater

Optional 3 kw heater05 ton chiller combo

Optional 9 kw heater 15 ton chiller combo

Load Cells 1 4 4 4 4

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 Built to GAMP5 standardsOptional 21 CFR Part 11 Compliant

Built to GAMP5 standards 21 CFR Part 11 Compliant

Hardware Rockwell Allen Bradley (Optional Delta-V)

Operator Interface Wonderware HMI (Optional Delta-V)

Data Historian Wonderware (Optional Delta-V)

Programming Rockwell Allen BradleyWonderware 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

wwwxcellerexcom bull 1-866-Xcellerex

7182019 XDR Datasheet

httpslidepdfcomreaderfullxdr-datasheet 47

PERFORMANCE CONTROL SPECIFICATIONS

XDR-50 XDR-200 XDR-500 XDR-1000 XDR-2000

pH Range 2-12 pH units

Accuracy plusmn 005 pH units

DO Range 0-100 atmospheric saturation

Accuracy plusmn 10 of setpoint

Sparge Rate (slpm) Air 0-5 0-5 0-10 0-10 0-10

Additional MFCsparge

ranges can be supplied

based on application

requirements

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

Temperature Range 4-60 ⁰C

Accuracy plusmn 02 ⁰C

Bag Pressure Range 0 - 30 psig (0 - 2068 mbar)

Accuracy plusmn 01 psig (plusmn 689 mbar)

Agitation (rpm) 0-400 0-350 0-250 0-140 0-115

Load Cell Accuracy plusmn 02 of max bag volume

Process OUR (mmolLh) Up to 100 covers all cell culture applications

k La (1h) 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 amp Control Unit)4 ft

(122M)6 ft

(183M)10 ft

(305M)17 ft

(518M)18 ft

(549M)

Depth (Vessel amp Control Unit) 35 ft(107M)

5 ft(152M)

5 ft(152M)

5 ft(152M)

5 ft(152M)

Height (Vessel amp Control Unit)75 ft

(229M)9 ft

(274M)10 ft

(305M)12 ft

(367M)14 ft

(427M)

Includes portable ladder for access to top of vessel

wwwxcellerexcom bull 1-866-Xcellerex

FULLY983085INTEGRATED XDR BIOREACTOR BAG ASSEMBLY

USP Class VIbull

LDPE fluid contact layerbull

Gamma Irradiatedbull

Validation Guide (available upon request)bull

Standard ldquooff-the-shelfrdquo 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)bull

Aseptic connectorsbull

Multiple feedaddition linesbull

Harvest linebull

Exhaust filterbull

Sparge filterbull

Overlay filterbull

Pressure sensorbull

Sampling portsbull

Probe portsbull

Thermowell (for temperature probe)bull

Proprietary XDR impellersparge systembull

7182019 XDR Datasheet

httpslidepdfcomreaderfullxdr-datasheet 57wwwxcellerexcom bull 1-866-Xcellerex

CONTROL AUTOMATION PLATFORMThe XDR Control Platform is comprised of a RockwellAllen 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 InterfaceThe 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 adjust-

ment 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)

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 permittinglive adjustments to ramp or step to new value (See Screen 3)

uPowerful Control Strategies for Fast Response Tight Control

bull Cascade control strategies of pH DO and volume result in very tight control of critical processconditions

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

bull Agitation bull Sparge

bull Gas mixing bull Gas overlay

bull Liquid addition and removal bull Temperature

bull pH bull DO (See Screen 4)

bull Weight

bull Dynamic reconguring of cascade control loops enables exceptional process exibility

uComprehensive Real-Time Data Capture Reporting and Trending

bull The real-time data historian captures all process parameters and times and oersaccessible look-up

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

bull Real time alarming protects process integrity and helps avoid lost batches

bull All alarms are logged to database

Screen 1 - System Overview

Screen 2 - Cascade Loop Control

Screen 3 -Set Point Automation Tables

Screen 4 - DO Strategy Set-Up Screen

7182019 XDR Datasheet

httpslidepdfcomreaderfullxdr-datasheet 67

XDR PERFORMANCE DATA

wwwxcellerexcom bull 1-866-Xcellerex

0

20

40

60

80

100

120

0 2 4 6 8 10

Day

T i t e r ( u g

m L )

XDR-1000

XDR-200

XDR-200

10L glass

10L glass

0

2

4

6

8

10

12

14

0 2 4 6 8 10

Day

V i a b l e c e l l s ( e 6 c e l l s m L )

0

20

40

60

80

100

XDR-1000

XDR-200

XDR-200

10L glass

10L glass

P er c en t V i a b l e

C el l s

0

2

4

6

8

10

12

14

0 5 10 15 20

Day

V i a b l e C e l l D e n s i t y ( e 6

c e l l s m L )

0

10

20

30

40

50

60

70

80

90

100

XDR-1000

10L glass

XDR-200

P er c

en t V i a b l e C el l s

Figure 1 CHO Process - Titer Data (XDR vs 10L Glass Reactor)

Figure 2 CHO Process - Viability Data (XDR vs 10L Glass Reactor)

Figure 3 CHO Perfusion Process - Viability Data (XDR vs 10L Glass Reactor)

Figures 1-3 illustrate examples of first-run datafor a series of CHO processes demonstrating theXDR systemrsquos ability to achieve immediate processequivalence Additional extensive data is availableon request

FIGURE 1 XDR achieved equivalent or better titerduring scale-up from a 10 liter glass reactor to a200 L XDR to a 1000 liter XDR

FIGURE 2 XDR achieved equivalent or better cellviability during scale-up from a 10 liter glass reac-tor to a 200L XDR to a 1000 liter XDR

FIGURE 3 XDR achieved process equivalence fora perfusion process at the 200L and 1000L scale

7182019 XDR Datasheet

httpslidepdfcomreaderfullxdr-datasheet 77

Xcellerex Inc Toll Free 1-866-Xcellerex

170 Locke Drive Tel 508-480-9235

Marlborough MA 01752 infoxcellerexcom

USA wwwxcellerexcom

rev xdr122309

TM

Single-Use Bioreactors amp Mixers Xcellerex single-use GMP bioreactors systems

outperform other disposables-based systems and

traditional stainless steel systems on the first run andevery run Unlike other bioreactors Xcellerex systems arefully integrated including a vessel control unit and theknowledge base that comes with the Xcellerex process

development and production teams

FlexFactoryreg Platform

FlexFactory is a portable modular all-disposablesbioproduction train that eliminates conventional clean

room requirements and delivers new production capacityin less than 1 year vs 3-5 years 50-70 less capital

investment 50 lower operating costs and multi-drugproduction with simple modifications to

modular components

Process Development ampGMP Manufacturing Services

To help clients eliminate many of the risks involved withdeploying new bioprocessing capacity Xcellerex offers a

world-class suite of technical services PDMaxreg Process Development services ensure you get an optimized

process fast Xcellerex GMP biomanufacturing servicesallow instant access to FlexFactory capacity for

evaluation purposes or as a bridge until your ownFlexFactory operation is ready for launch

Co-Developed ampProprietary Molecules

Xcellerex is so passionate about the power of ourtechnology that we are working with partners to develop aportfolio of proprietary molecules enabled by t he Xcellerex

platform Sourced primarily through in-licensing theseprograms enable Xcellerex to demonstrate our conviction

in the FlexFactory model while also continuouslyenhancing our technology and expanding ourknowledge base for the benefit of customers

and partners

ABOUT XCELLEREXXcellerex offers a unique blend of bioprocess systems platform technology and services delivered by a team with deep

roots as biomanufacturing practitioners

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 salesxcellerexcom

Page 2: XDR Datasheet

7182019 XDR Datasheet

httpslidepdfcomreaderfullxdr-datasheet 27

agitator includes a HDPE bottom mounted impeller and a

unique sparge system consisting of microporous stainless

steel disks and optional drilled holes that together impart

the system with tremendous flexibility crucial for todayrsquos cell

culture processes Xcellerex also maintains multiple supply

sources to guard against supply chain disruptions

Expert process support from Xcellerex With years

of experience running and supporting GMP biomanufactur-

ing operations Xcellerex designed the XDR system to deliver

complete process control from the moment each system

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

XDRrsquos depth of characterization process support and GMP-

readiness Xcellerex is uniquely able to deliver critical control

automation with instrumentation functionality process mod

eling tech transfer and scalability

Key XDR Advantages

u 51 turndown means each XDR can operate at 20 of maximum workingvolume doing the work of multiple reactors

u True plug-and-play performance Connect gases and power and getstarted

u Robust self-installing magnetically-driven bottom-mount impellerNo rotating seals insertable shafts and connection hassles

u Jacketed vessel ensures uniform temperature distribution throughoutreactor

u Flexible control systems automate temperature shifts feeds changes tosparge composition

u Multiple probe configurations available including pH DO CO2 andbiomass

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

u Bag material sourced from multiple manufacturers for supply chain security

u Single-use design eliminates time consuming CIP SIP and cleaning valida-tions procedures

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

u Each XDR Single Use Reactor System is shipped with a Turnover Packagewhich includes XDR Operating Manual System S pecifications FATcommissioning report system drawings component operating manualscalibration records and optional IQOQ protocols

u Xcellerex process experience and know how is built into every XDRSystem our process development expertise ensures that the process isup and running right the first time

u Xcellerex offers extensive XDR-specific predictive modeling and expertscale-up support

u Enhanced sparge control and CO2 stripping capabilities not offered onother single use systems

u Designed and fully characterized to deliver scalable cGMP processes from10L to 2000L

u Xcellerex has years of cGMP manufacturing experience operating the XDRsystem GMP product made in the XDR is currently being used in clinicaltrials and commercial XDR facilities are currently being prepared for com-missioning

wwwxcellerexcom bull 1-866-Xcellerex

uPowerful User-Friendly Controls The XDR is

equipped with a fully integrated control console

featuring intuitive process controls

data historian and robust automa-

tion hardwaresoftware The system

enables precise process control

and offers convenient real-timetrending and other valuable data

When coupled with Xcellerexrsquos

process development experience

and predictive modeling support

the XDR control platform assures optimized first-run

process performance and reliability through tech

transfer and scale-up

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

7182019 XDR Datasheet

httpslidepdfcomreaderfullxdr-datasheet 37

SYSTEM SPECIFICATIONS

XDR-50 XDR-200 XDR-500 XDR-1000 XDR-2000

BIOREACTOR

Max Working Volume (L) 50 200 500 1000 2000

Min Working Volume (L) 10 40 100 200 400

Volume turn-down ratio 51 51 51 51 51

Tank ID (in) 12 22 30 38 48

Liquid height max Vw (in) 30 335 456 567 709

HD 25 15 15 15 15

Vessel Material of Construction Jacketed 304 SS Jacketed 304 SS Jacketed 304 SS Jacketed 304 SS Jacketed 304 SS

Filter Heater Box 1 1 1 1 1

Bag Hoist NA NA NA Automated Automated

Agitation

Motor Servo

LiftPositionLoweredraised to center

LiftPositionLoweredraised to 15⁰ off-center

Impeller Bottom mounted magnetically-driven single-use impeller integrated with bag assembly

Impeller type M40ENo of impellers blades 13 13 13 13 14

Impeller diameter (in) 8 8 10 12 16

DiDt 067 036 033 033 033

No of baffles 0 0 0 0 0

Impeller location Center 90⁰ 15⁰ off center 15⁰ off center 15⁰ off center 15⁰ off center

Sparger

S ta nd ar d S ta nl es s s te el s in te re d d is ks S ta nl es s s te el s in te re d d is ks S ta nl es s s te el s in te re d d is ks S ta nl es s s te el s in te re d d is ks S ta nl es s s te el s in te re d d is ks

OptionalDrilled Hole Drilled Hole Drilled Hole Drilled Hole Drilled Hole

CO2 stripping CO2 stripping CO2 stripping CO2 stripping CO2 stripping

PROCESS INSTRUMENTATION

pH probes 1 2 2 2 2

DO probes 1 2 2 2 2

Rotometer-01 1 na na na na

MFCs (Brooks)Standard 3 4 4 4 4

Additional (optional) 3 2 2 2 2

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

Temperature Control Unit Optional 3 kw heater Optional 9 kw heater

Optional 3 kw heater05 ton chiller combo

Optional 9 kw heater 15 ton chiller combo

Load Cells 1 4 4 4 4

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 Built to GAMP5 standardsOptional 21 CFR Part 11 Compliant

Built to GAMP5 standards 21 CFR Part 11 Compliant

Hardware Rockwell Allen Bradley (Optional Delta-V)

Operator Interface Wonderware HMI (Optional Delta-V)

Data Historian Wonderware (Optional Delta-V)

Programming Rockwell Allen BradleyWonderware 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

wwwxcellerexcom bull 1-866-Xcellerex

7182019 XDR Datasheet

httpslidepdfcomreaderfullxdr-datasheet 47

PERFORMANCE CONTROL SPECIFICATIONS

XDR-50 XDR-200 XDR-500 XDR-1000 XDR-2000

pH Range 2-12 pH units

Accuracy plusmn 005 pH units

DO Range 0-100 atmospheric saturation

Accuracy plusmn 10 of setpoint

Sparge Rate (slpm) Air 0-5 0-5 0-10 0-10 0-10

Additional MFCsparge

ranges can be supplied

based on application

requirements

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

Temperature Range 4-60 ⁰C

Accuracy plusmn 02 ⁰C

Bag Pressure Range 0 - 30 psig (0 - 2068 mbar)

Accuracy plusmn 01 psig (plusmn 689 mbar)

Agitation (rpm) 0-400 0-350 0-250 0-140 0-115

Load Cell Accuracy plusmn 02 of max bag volume

Process OUR (mmolLh) Up to 100 covers all cell culture applications

k La (1h) 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 amp Control Unit)4 ft

(122M)6 ft

(183M)10 ft

(305M)17 ft

(518M)18 ft

(549M)

Depth (Vessel amp Control Unit) 35 ft(107M)

5 ft(152M)

5 ft(152M)

5 ft(152M)

5 ft(152M)

Height (Vessel amp Control Unit)75 ft

(229M)9 ft

(274M)10 ft

(305M)12 ft

(367M)14 ft

(427M)

Includes portable ladder for access to top of vessel

wwwxcellerexcom bull 1-866-Xcellerex

FULLY983085INTEGRATED XDR BIOREACTOR BAG ASSEMBLY

USP Class VIbull

LDPE fluid contact layerbull

Gamma Irradiatedbull

Validation Guide (available upon request)bull

Standard ldquooff-the-shelfrdquo 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)bull

Aseptic connectorsbull

Multiple feedaddition linesbull

Harvest linebull

Exhaust filterbull

Sparge filterbull

Overlay filterbull

Pressure sensorbull

Sampling portsbull

Probe portsbull

Thermowell (for temperature probe)bull

Proprietary XDR impellersparge systembull

7182019 XDR Datasheet

httpslidepdfcomreaderfullxdr-datasheet 57wwwxcellerexcom bull 1-866-Xcellerex

CONTROL AUTOMATION PLATFORMThe XDR Control Platform is comprised of a RockwellAllen 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 InterfaceThe 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 adjust-

ment 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)

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 permittinglive adjustments to ramp or step to new value (See Screen 3)

uPowerful Control Strategies for Fast Response Tight Control

bull Cascade control strategies of pH DO and volume result in very tight control of critical processconditions

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

bull Agitation bull Sparge

bull Gas mixing bull Gas overlay

bull Liquid addition and removal bull Temperature

bull pH bull DO (See Screen 4)

bull Weight

bull Dynamic reconguring of cascade control loops enables exceptional process exibility

uComprehensive Real-Time Data Capture Reporting and Trending

bull The real-time data historian captures all process parameters and times and oersaccessible look-up

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

bull Real time alarming protects process integrity and helps avoid lost batches

bull All alarms are logged to database

Screen 1 - System Overview

Screen 2 - Cascade Loop Control

Screen 3 -Set Point Automation Tables

Screen 4 - DO Strategy Set-Up Screen

7182019 XDR Datasheet

httpslidepdfcomreaderfullxdr-datasheet 67

XDR PERFORMANCE DATA

wwwxcellerexcom bull 1-866-Xcellerex

0

20

40

60

80

100

120

0 2 4 6 8 10

Day

T i t e r ( u g

m L )

XDR-1000

XDR-200

XDR-200

10L glass

10L glass

0

2

4

6

8

10

12

14

0 2 4 6 8 10

Day

V i a b l e c e l l s ( e 6 c e l l s m L )

0

20

40

60

80

100

XDR-1000

XDR-200

XDR-200

10L glass

10L glass

P er c en t V i a b l e

C el l s

0

2

4

6

8

10

12

14

0 5 10 15 20

Day

V i a b l e C e l l D e n s i t y ( e 6

c e l l s m L )

0

10

20

30

40

50

60

70

80

90

100

XDR-1000

10L glass

XDR-200

P er c

en t V i a b l e C el l s

Figure 1 CHO Process - Titer Data (XDR vs 10L Glass Reactor)

Figure 2 CHO Process - Viability Data (XDR vs 10L Glass Reactor)

Figure 3 CHO Perfusion Process - Viability Data (XDR vs 10L Glass Reactor)

Figures 1-3 illustrate examples of first-run datafor a series of CHO processes demonstrating theXDR systemrsquos ability to achieve immediate processequivalence Additional extensive data is availableon request

FIGURE 1 XDR achieved equivalent or better titerduring scale-up from a 10 liter glass reactor to a200 L XDR to a 1000 liter XDR

FIGURE 2 XDR achieved equivalent or better cellviability during scale-up from a 10 liter glass reac-tor to a 200L XDR to a 1000 liter XDR

FIGURE 3 XDR achieved process equivalence fora perfusion process at the 200L and 1000L scale

7182019 XDR Datasheet

httpslidepdfcomreaderfullxdr-datasheet 77

Xcellerex Inc Toll Free 1-866-Xcellerex

170 Locke Drive Tel 508-480-9235

Marlborough MA 01752 infoxcellerexcom

USA wwwxcellerexcom

rev xdr122309

TM

Single-Use Bioreactors amp Mixers Xcellerex single-use GMP bioreactors systems

outperform other disposables-based systems and

traditional stainless steel systems on the first run andevery run Unlike other bioreactors Xcellerex systems arefully integrated including a vessel control unit and theknowledge base that comes with the Xcellerex process

development and production teams

FlexFactoryreg Platform

FlexFactory is a portable modular all-disposablesbioproduction train that eliminates conventional clean

room requirements and delivers new production capacityin less than 1 year vs 3-5 years 50-70 less capital

investment 50 lower operating costs and multi-drugproduction with simple modifications to

modular components

Process Development ampGMP Manufacturing Services

To help clients eliminate many of the risks involved withdeploying new bioprocessing capacity Xcellerex offers a

world-class suite of technical services PDMaxreg Process Development services ensure you get an optimized

process fast Xcellerex GMP biomanufacturing servicesallow instant access to FlexFactory capacity for

evaluation purposes or as a bridge until your ownFlexFactory operation is ready for launch

Co-Developed ampProprietary Molecules

Xcellerex is so passionate about the power of ourtechnology that we are working with partners to develop aportfolio of proprietary molecules enabled by t he Xcellerex

platform Sourced primarily through in-licensing theseprograms enable Xcellerex to demonstrate our conviction

in the FlexFactory model while also continuouslyenhancing our technology and expanding ourknowledge base for the benefit of customers

and partners

ABOUT XCELLEREXXcellerex offers a unique blend of bioprocess systems platform technology and services delivered by a team with deep

roots as biomanufacturing practitioners

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 salesxcellerexcom

Page 3: XDR Datasheet

7182019 XDR Datasheet

httpslidepdfcomreaderfullxdr-datasheet 37

SYSTEM SPECIFICATIONS

XDR-50 XDR-200 XDR-500 XDR-1000 XDR-2000

BIOREACTOR

Max Working Volume (L) 50 200 500 1000 2000

Min Working Volume (L) 10 40 100 200 400

Volume turn-down ratio 51 51 51 51 51

Tank ID (in) 12 22 30 38 48

Liquid height max Vw (in) 30 335 456 567 709

HD 25 15 15 15 15

Vessel Material of Construction Jacketed 304 SS Jacketed 304 SS Jacketed 304 SS Jacketed 304 SS Jacketed 304 SS

Filter Heater Box 1 1 1 1 1

Bag Hoist NA NA NA Automated Automated

Agitation

Motor Servo

LiftPositionLoweredraised to center

LiftPositionLoweredraised to 15⁰ off-center

Impeller Bottom mounted magnetically-driven single-use impeller integrated with bag assembly

Impeller type M40ENo of impellers blades 13 13 13 13 14

Impeller diameter (in) 8 8 10 12 16

DiDt 067 036 033 033 033

No of baffles 0 0 0 0 0

Impeller location Center 90⁰ 15⁰ off center 15⁰ off center 15⁰ off center 15⁰ off center

Sparger

S ta nd ar d S ta nl es s s te el s in te re d d is ks S ta nl es s s te el s in te re d d is ks S ta nl es s s te el s in te re d d is ks S ta nl es s s te el s in te re d d is ks S ta nl es s s te el s in te re d d is ks

OptionalDrilled Hole Drilled Hole Drilled Hole Drilled Hole Drilled Hole

CO2 stripping CO2 stripping CO2 stripping CO2 stripping CO2 stripping

PROCESS INSTRUMENTATION

pH probes 1 2 2 2 2

DO probes 1 2 2 2 2

Rotometer-01 1 na na na na

MFCs (Brooks)Standard 3 4 4 4 4

Additional (optional) 3 2 2 2 2

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

Temperature Control Unit Optional 3 kw heater Optional 9 kw heater

Optional 3 kw heater05 ton chiller combo

Optional 9 kw heater 15 ton chiller combo

Load Cells 1 4 4 4 4

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 Built to GAMP5 standardsOptional 21 CFR Part 11 Compliant

Built to GAMP5 standards 21 CFR Part 11 Compliant

Hardware Rockwell Allen Bradley (Optional Delta-V)

Operator Interface Wonderware HMI (Optional Delta-V)

Data Historian Wonderware (Optional Delta-V)

Programming Rockwell Allen BradleyWonderware 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

wwwxcellerexcom bull 1-866-Xcellerex

7182019 XDR Datasheet

httpslidepdfcomreaderfullxdr-datasheet 47

PERFORMANCE CONTROL SPECIFICATIONS

XDR-50 XDR-200 XDR-500 XDR-1000 XDR-2000

pH Range 2-12 pH units

Accuracy plusmn 005 pH units

DO Range 0-100 atmospheric saturation

Accuracy plusmn 10 of setpoint

Sparge Rate (slpm) Air 0-5 0-5 0-10 0-10 0-10

Additional MFCsparge

ranges can be supplied

based on application

requirements

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

Temperature Range 4-60 ⁰C

Accuracy plusmn 02 ⁰C

Bag Pressure Range 0 - 30 psig (0 - 2068 mbar)

Accuracy plusmn 01 psig (plusmn 689 mbar)

Agitation (rpm) 0-400 0-350 0-250 0-140 0-115

Load Cell Accuracy plusmn 02 of max bag volume

Process OUR (mmolLh) Up to 100 covers all cell culture applications

k La (1h) 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 amp Control Unit)4 ft

(122M)6 ft

(183M)10 ft

(305M)17 ft

(518M)18 ft

(549M)

Depth (Vessel amp Control Unit) 35 ft(107M)

5 ft(152M)

5 ft(152M)

5 ft(152M)

5 ft(152M)

Height (Vessel amp Control Unit)75 ft

(229M)9 ft

(274M)10 ft

(305M)12 ft

(367M)14 ft

(427M)

Includes portable ladder for access to top of vessel

wwwxcellerexcom bull 1-866-Xcellerex

FULLY983085INTEGRATED XDR BIOREACTOR BAG ASSEMBLY

USP Class VIbull

LDPE fluid contact layerbull

Gamma Irradiatedbull

Validation Guide (available upon request)bull

Standard ldquooff-the-shelfrdquo 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)bull

Aseptic connectorsbull

Multiple feedaddition linesbull

Harvest linebull

Exhaust filterbull

Sparge filterbull

Overlay filterbull

Pressure sensorbull

Sampling portsbull

Probe portsbull

Thermowell (for temperature probe)bull

Proprietary XDR impellersparge systembull

7182019 XDR Datasheet

httpslidepdfcomreaderfullxdr-datasheet 57wwwxcellerexcom bull 1-866-Xcellerex

CONTROL AUTOMATION PLATFORMThe XDR Control Platform is comprised of a RockwellAllen 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 InterfaceThe 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 adjust-

ment 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)

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 permittinglive adjustments to ramp or step to new value (See Screen 3)

uPowerful Control Strategies for Fast Response Tight Control

bull Cascade control strategies of pH DO and volume result in very tight control of critical processconditions

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

bull Agitation bull Sparge

bull Gas mixing bull Gas overlay

bull Liquid addition and removal bull Temperature

bull pH bull DO (See Screen 4)

bull Weight

bull Dynamic reconguring of cascade control loops enables exceptional process exibility

uComprehensive Real-Time Data Capture Reporting and Trending

bull The real-time data historian captures all process parameters and times and oersaccessible look-up

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

bull Real time alarming protects process integrity and helps avoid lost batches

bull All alarms are logged to database

Screen 1 - System Overview

Screen 2 - Cascade Loop Control

Screen 3 -Set Point Automation Tables

Screen 4 - DO Strategy Set-Up Screen

7182019 XDR Datasheet

httpslidepdfcomreaderfullxdr-datasheet 67

XDR PERFORMANCE DATA

wwwxcellerexcom bull 1-866-Xcellerex

0

20

40

60

80

100

120

0 2 4 6 8 10

Day

T i t e r ( u g

m L )

XDR-1000

XDR-200

XDR-200

10L glass

10L glass

0

2

4

6

8

10

12

14

0 2 4 6 8 10

Day

V i a b l e c e l l s ( e 6 c e l l s m L )

0

20

40

60

80

100

XDR-1000

XDR-200

XDR-200

10L glass

10L glass

P er c en t V i a b l e

C el l s

0

2

4

6

8

10

12

14

0 5 10 15 20

Day

V i a b l e C e l l D e n s i t y ( e 6

c e l l s m L )

0

10

20

30

40

50

60

70

80

90

100

XDR-1000

10L glass

XDR-200

P er c

en t V i a b l e C el l s

Figure 1 CHO Process - Titer Data (XDR vs 10L Glass Reactor)

Figure 2 CHO Process - Viability Data (XDR vs 10L Glass Reactor)

Figure 3 CHO Perfusion Process - Viability Data (XDR vs 10L Glass Reactor)

Figures 1-3 illustrate examples of first-run datafor a series of CHO processes demonstrating theXDR systemrsquos ability to achieve immediate processequivalence Additional extensive data is availableon request

FIGURE 1 XDR achieved equivalent or better titerduring scale-up from a 10 liter glass reactor to a200 L XDR to a 1000 liter XDR

FIGURE 2 XDR achieved equivalent or better cellviability during scale-up from a 10 liter glass reac-tor to a 200L XDR to a 1000 liter XDR

FIGURE 3 XDR achieved process equivalence fora perfusion process at the 200L and 1000L scale

7182019 XDR Datasheet

httpslidepdfcomreaderfullxdr-datasheet 77

Xcellerex Inc Toll Free 1-866-Xcellerex

170 Locke Drive Tel 508-480-9235

Marlborough MA 01752 infoxcellerexcom

USA wwwxcellerexcom

rev xdr122309

TM

Single-Use Bioreactors amp Mixers Xcellerex single-use GMP bioreactors systems

outperform other disposables-based systems and

traditional stainless steel systems on the first run andevery run Unlike other bioreactors Xcellerex systems arefully integrated including a vessel control unit and theknowledge base that comes with the Xcellerex process

development and production teams

FlexFactoryreg Platform

FlexFactory is a portable modular all-disposablesbioproduction train that eliminates conventional clean

room requirements and delivers new production capacityin less than 1 year vs 3-5 years 50-70 less capital

investment 50 lower operating costs and multi-drugproduction with simple modifications to

modular components

Process Development ampGMP Manufacturing Services

To help clients eliminate many of the risks involved withdeploying new bioprocessing capacity Xcellerex offers a

world-class suite of technical services PDMaxreg Process Development services ensure you get an optimized

process fast Xcellerex GMP biomanufacturing servicesallow instant access to FlexFactory capacity for

evaluation purposes or as a bridge until your ownFlexFactory operation is ready for launch

Co-Developed ampProprietary Molecules

Xcellerex is so passionate about the power of ourtechnology that we are working with partners to develop aportfolio of proprietary molecules enabled by t he Xcellerex

platform Sourced primarily through in-licensing theseprograms enable Xcellerex to demonstrate our conviction

in the FlexFactory model while also continuouslyenhancing our technology and expanding ourknowledge base for the benefit of customers

and partners

ABOUT XCELLEREXXcellerex offers a unique blend of bioprocess systems platform technology and services delivered by a team with deep

roots as biomanufacturing practitioners

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 salesxcellerexcom

Page 4: XDR Datasheet

7182019 XDR Datasheet

httpslidepdfcomreaderfullxdr-datasheet 47

PERFORMANCE CONTROL SPECIFICATIONS

XDR-50 XDR-200 XDR-500 XDR-1000 XDR-2000

pH Range 2-12 pH units

Accuracy plusmn 005 pH units

DO Range 0-100 atmospheric saturation

Accuracy plusmn 10 of setpoint

Sparge Rate (slpm) Air 0-5 0-5 0-10 0-10 0-10

Additional MFCsparge

ranges can be supplied

based on application

requirements

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

Temperature Range 4-60 ⁰C

Accuracy plusmn 02 ⁰C

Bag Pressure Range 0 - 30 psig (0 - 2068 mbar)

Accuracy plusmn 01 psig (plusmn 689 mbar)

Agitation (rpm) 0-400 0-350 0-250 0-140 0-115

Load Cell Accuracy plusmn 02 of max bag volume

Process OUR (mmolLh) Up to 100 covers all cell culture applications

k La (1h) 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 amp Control Unit)4 ft

(122M)6 ft

(183M)10 ft

(305M)17 ft

(518M)18 ft

(549M)

Depth (Vessel amp Control Unit) 35 ft(107M)

5 ft(152M)

5 ft(152M)

5 ft(152M)

5 ft(152M)

Height (Vessel amp Control Unit)75 ft

(229M)9 ft

(274M)10 ft

(305M)12 ft

(367M)14 ft

(427M)

Includes portable ladder for access to top of vessel

wwwxcellerexcom bull 1-866-Xcellerex

FULLY983085INTEGRATED XDR BIOREACTOR BAG ASSEMBLY

USP Class VIbull

LDPE fluid contact layerbull

Gamma Irradiatedbull

Validation Guide (available upon request)bull

Standard ldquooff-the-shelfrdquo 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)bull

Aseptic connectorsbull

Multiple feedaddition linesbull

Harvest linebull

Exhaust filterbull

Sparge filterbull

Overlay filterbull

Pressure sensorbull

Sampling portsbull

Probe portsbull

Thermowell (for temperature probe)bull

Proprietary XDR impellersparge systembull

7182019 XDR Datasheet

httpslidepdfcomreaderfullxdr-datasheet 57wwwxcellerexcom bull 1-866-Xcellerex

CONTROL AUTOMATION PLATFORMThe XDR Control Platform is comprised of a RockwellAllen 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 InterfaceThe 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 adjust-

ment 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)

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 permittinglive adjustments to ramp or step to new value (See Screen 3)

uPowerful Control Strategies for Fast Response Tight Control

bull Cascade control strategies of pH DO and volume result in very tight control of critical processconditions

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

bull Agitation bull Sparge

bull Gas mixing bull Gas overlay

bull Liquid addition and removal bull Temperature

bull pH bull DO (See Screen 4)

bull Weight

bull Dynamic reconguring of cascade control loops enables exceptional process exibility

uComprehensive Real-Time Data Capture Reporting and Trending

bull The real-time data historian captures all process parameters and times and oersaccessible look-up

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

bull Real time alarming protects process integrity and helps avoid lost batches

bull All alarms are logged to database

Screen 1 - System Overview

Screen 2 - Cascade Loop Control

Screen 3 -Set Point Automation Tables

Screen 4 - DO Strategy Set-Up Screen

7182019 XDR Datasheet

httpslidepdfcomreaderfullxdr-datasheet 67

XDR PERFORMANCE DATA

wwwxcellerexcom bull 1-866-Xcellerex

0

20

40

60

80

100

120

0 2 4 6 8 10

Day

T i t e r ( u g

m L )

XDR-1000

XDR-200

XDR-200

10L glass

10L glass

0

2

4

6

8

10

12

14

0 2 4 6 8 10

Day

V i a b l e c e l l s ( e 6 c e l l s m L )

0

20

40

60

80

100

XDR-1000

XDR-200

XDR-200

10L glass

10L glass

P er c en t V i a b l e

C el l s

0

2

4

6

8

10

12

14

0 5 10 15 20

Day

V i a b l e C e l l D e n s i t y ( e 6

c e l l s m L )

0

10

20

30

40

50

60

70

80

90

100

XDR-1000

10L glass

XDR-200

P er c

en t V i a b l e C el l s

Figure 1 CHO Process - Titer Data (XDR vs 10L Glass Reactor)

Figure 2 CHO Process - Viability Data (XDR vs 10L Glass Reactor)

Figure 3 CHO Perfusion Process - Viability Data (XDR vs 10L Glass Reactor)

Figures 1-3 illustrate examples of first-run datafor a series of CHO processes demonstrating theXDR systemrsquos ability to achieve immediate processequivalence Additional extensive data is availableon request

FIGURE 1 XDR achieved equivalent or better titerduring scale-up from a 10 liter glass reactor to a200 L XDR to a 1000 liter XDR

FIGURE 2 XDR achieved equivalent or better cellviability during scale-up from a 10 liter glass reac-tor to a 200L XDR to a 1000 liter XDR

FIGURE 3 XDR achieved process equivalence fora perfusion process at the 200L and 1000L scale

7182019 XDR Datasheet

httpslidepdfcomreaderfullxdr-datasheet 77

Xcellerex Inc Toll Free 1-866-Xcellerex

170 Locke Drive Tel 508-480-9235

Marlborough MA 01752 infoxcellerexcom

USA wwwxcellerexcom

rev xdr122309

TM

Single-Use Bioreactors amp Mixers Xcellerex single-use GMP bioreactors systems

outperform other disposables-based systems and

traditional stainless steel systems on the first run andevery run Unlike other bioreactors Xcellerex systems arefully integrated including a vessel control unit and theknowledge base that comes with the Xcellerex process

development and production teams

FlexFactoryreg Platform

FlexFactory is a portable modular all-disposablesbioproduction train that eliminates conventional clean

room requirements and delivers new production capacityin less than 1 year vs 3-5 years 50-70 less capital

investment 50 lower operating costs and multi-drugproduction with simple modifications to

modular components

Process Development ampGMP Manufacturing Services

To help clients eliminate many of the risks involved withdeploying new bioprocessing capacity Xcellerex offers a

world-class suite of technical services PDMaxreg Process Development services ensure you get an optimized

process fast Xcellerex GMP biomanufacturing servicesallow instant access to FlexFactory capacity for

evaluation purposes or as a bridge until your ownFlexFactory operation is ready for launch

Co-Developed ampProprietary Molecules

Xcellerex is so passionate about the power of ourtechnology that we are working with partners to develop aportfolio of proprietary molecules enabled by t he Xcellerex

platform Sourced primarily through in-licensing theseprograms enable Xcellerex to demonstrate our conviction

in the FlexFactory model while also continuouslyenhancing our technology and expanding ourknowledge base for the benefit of customers

and partners

ABOUT XCELLEREXXcellerex offers a unique blend of bioprocess systems platform technology and services delivered by a team with deep

roots as biomanufacturing practitioners

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 salesxcellerexcom

Page 5: XDR Datasheet

7182019 XDR Datasheet

httpslidepdfcomreaderfullxdr-datasheet 57wwwxcellerexcom bull 1-866-Xcellerex

CONTROL AUTOMATION PLATFORMThe XDR Control Platform is comprised of a RockwellAllen 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 InterfaceThe 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 adjust-

ment 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)

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 permittinglive adjustments to ramp or step to new value (See Screen 3)

uPowerful Control Strategies for Fast Response Tight Control

bull Cascade control strategies of pH DO and volume result in very tight control of critical processconditions

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

bull Agitation bull Sparge

bull Gas mixing bull Gas overlay

bull Liquid addition and removal bull Temperature

bull pH bull DO (See Screen 4)

bull Weight

bull Dynamic reconguring of cascade control loops enables exceptional process exibility

uComprehensive Real-Time Data Capture Reporting and Trending

bull The real-time data historian captures all process parameters and times and oersaccessible look-up

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

bull Real time alarming protects process integrity and helps avoid lost batches

bull All alarms are logged to database

Screen 1 - System Overview

Screen 2 - Cascade Loop Control

Screen 3 -Set Point Automation Tables

Screen 4 - DO Strategy Set-Up Screen

7182019 XDR Datasheet

httpslidepdfcomreaderfullxdr-datasheet 67

XDR PERFORMANCE DATA

wwwxcellerexcom bull 1-866-Xcellerex

0

20

40

60

80

100

120

0 2 4 6 8 10

Day

T i t e r ( u g

m L )

XDR-1000

XDR-200

XDR-200

10L glass

10L glass

0

2

4

6

8

10

12

14

0 2 4 6 8 10

Day

V i a b l e c e l l s ( e 6 c e l l s m L )

0

20

40

60

80

100

XDR-1000

XDR-200

XDR-200

10L glass

10L glass

P er c en t V i a b l e

C el l s

0

2

4

6

8

10

12

14

0 5 10 15 20

Day

V i a b l e C e l l D e n s i t y ( e 6

c e l l s m L )

0

10

20

30

40

50

60

70

80

90

100

XDR-1000

10L glass

XDR-200

P er c

en t V i a b l e C el l s

Figure 1 CHO Process - Titer Data (XDR vs 10L Glass Reactor)

Figure 2 CHO Process - Viability Data (XDR vs 10L Glass Reactor)

Figure 3 CHO Perfusion Process - Viability Data (XDR vs 10L Glass Reactor)

Figures 1-3 illustrate examples of first-run datafor a series of CHO processes demonstrating theXDR systemrsquos ability to achieve immediate processequivalence Additional extensive data is availableon request

FIGURE 1 XDR achieved equivalent or better titerduring scale-up from a 10 liter glass reactor to a200 L XDR to a 1000 liter XDR

FIGURE 2 XDR achieved equivalent or better cellviability during scale-up from a 10 liter glass reac-tor to a 200L XDR to a 1000 liter XDR

FIGURE 3 XDR achieved process equivalence fora perfusion process at the 200L and 1000L scale

7182019 XDR Datasheet

httpslidepdfcomreaderfullxdr-datasheet 77

Xcellerex Inc Toll Free 1-866-Xcellerex

170 Locke Drive Tel 508-480-9235

Marlborough MA 01752 infoxcellerexcom

USA wwwxcellerexcom

rev xdr122309

TM

Single-Use Bioreactors amp Mixers Xcellerex single-use GMP bioreactors systems

outperform other disposables-based systems and

traditional stainless steel systems on the first run andevery run Unlike other bioreactors Xcellerex systems arefully integrated including a vessel control unit and theknowledge base that comes with the Xcellerex process

development and production teams

FlexFactoryreg Platform

FlexFactory is a portable modular all-disposablesbioproduction train that eliminates conventional clean

room requirements and delivers new production capacityin less than 1 year vs 3-5 years 50-70 less capital

investment 50 lower operating costs and multi-drugproduction with simple modifications to

modular components

Process Development ampGMP Manufacturing Services

To help clients eliminate many of the risks involved withdeploying new bioprocessing capacity Xcellerex offers a

world-class suite of technical services PDMaxreg Process Development services ensure you get an optimized

process fast Xcellerex GMP biomanufacturing servicesallow instant access to FlexFactory capacity for

evaluation purposes or as a bridge until your ownFlexFactory operation is ready for launch

Co-Developed ampProprietary Molecules

Xcellerex is so passionate about the power of ourtechnology that we are working with partners to develop aportfolio of proprietary molecules enabled by t he Xcellerex

platform Sourced primarily through in-licensing theseprograms enable Xcellerex to demonstrate our conviction

in the FlexFactory model while also continuouslyenhancing our technology and expanding ourknowledge base for the benefit of customers

and partners

ABOUT XCELLEREXXcellerex offers a unique blend of bioprocess systems platform technology and services delivered by a team with deep

roots as biomanufacturing practitioners

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 salesxcellerexcom

Page 6: XDR Datasheet

7182019 XDR Datasheet

httpslidepdfcomreaderfullxdr-datasheet 67

XDR PERFORMANCE DATA

wwwxcellerexcom bull 1-866-Xcellerex

0

20

40

60

80

100

120

0 2 4 6 8 10

Day

T i t e r ( u g

m L )

XDR-1000

XDR-200

XDR-200

10L glass

10L glass

0

2

4

6

8

10

12

14

0 2 4 6 8 10

Day

V i a b l e c e l l s ( e 6 c e l l s m L )

0

20

40

60

80

100

XDR-1000

XDR-200

XDR-200

10L glass

10L glass

P er c en t V i a b l e

C el l s

0

2

4

6

8

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0 5 10 15 20

Day

V i a b l e C e l l D e n s i t y ( e 6

c e l l s m L )

0

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30

40

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60

70

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90

100

XDR-1000

10L glass

XDR-200

P er c

en t V i a b l e C el l s

Figure 1 CHO Process - Titer Data (XDR vs 10L Glass Reactor)

Figure 2 CHO Process - Viability Data (XDR vs 10L Glass Reactor)

Figure 3 CHO Perfusion Process - Viability Data (XDR vs 10L Glass Reactor)

Figures 1-3 illustrate examples of first-run datafor a series of CHO processes demonstrating theXDR systemrsquos ability to achieve immediate processequivalence Additional extensive data is availableon request

FIGURE 1 XDR achieved equivalent or better titerduring scale-up from a 10 liter glass reactor to a200 L XDR to a 1000 liter XDR

FIGURE 2 XDR achieved equivalent or better cellviability during scale-up from a 10 liter glass reac-tor to a 200L XDR to a 1000 liter XDR

FIGURE 3 XDR achieved process equivalence fora perfusion process at the 200L and 1000L scale

7182019 XDR Datasheet

httpslidepdfcomreaderfullxdr-datasheet 77

Xcellerex Inc Toll Free 1-866-Xcellerex

170 Locke Drive Tel 508-480-9235

Marlborough MA 01752 infoxcellerexcom

USA wwwxcellerexcom

rev xdr122309

TM

Single-Use Bioreactors amp Mixers Xcellerex single-use GMP bioreactors systems

outperform other disposables-based systems and

traditional stainless steel systems on the first run andevery run Unlike other bioreactors Xcellerex systems arefully integrated including a vessel control unit and theknowledge base that comes with the Xcellerex process

development and production teams

FlexFactoryreg Platform

FlexFactory is a portable modular all-disposablesbioproduction train that eliminates conventional clean

room requirements and delivers new production capacityin less than 1 year vs 3-5 years 50-70 less capital

investment 50 lower operating costs and multi-drugproduction with simple modifications to

modular components

Process Development ampGMP Manufacturing Services

To help clients eliminate many of the risks involved withdeploying new bioprocessing capacity Xcellerex offers a

world-class suite of technical services PDMaxreg Process Development services ensure you get an optimized

process fast Xcellerex GMP biomanufacturing servicesallow instant access to FlexFactory capacity for

evaluation purposes or as a bridge until your ownFlexFactory operation is ready for launch

Co-Developed ampProprietary Molecules

Xcellerex is so passionate about the power of ourtechnology that we are working with partners to develop aportfolio of proprietary molecules enabled by t he Xcellerex

platform Sourced primarily through in-licensing theseprograms enable Xcellerex to demonstrate our conviction

in the FlexFactory model while also continuouslyenhancing our technology and expanding ourknowledge base for the benefit of customers

and partners

ABOUT XCELLEREXXcellerex offers a unique blend of bioprocess systems platform technology and services delivered by a team with deep

roots as biomanufacturing practitioners

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 salesxcellerexcom

Page 7: XDR Datasheet

7182019 XDR Datasheet

httpslidepdfcomreaderfullxdr-datasheet 77

Xcellerex Inc Toll Free 1-866-Xcellerex

170 Locke Drive Tel 508-480-9235

Marlborough MA 01752 infoxcellerexcom

USA wwwxcellerexcom

rev xdr122309

TM

Single-Use Bioreactors amp Mixers Xcellerex single-use GMP bioreactors systems

outperform other disposables-based systems and

traditional stainless steel systems on the first run andevery run Unlike other bioreactors Xcellerex systems arefully integrated including a vessel control unit and theknowledge base that comes with the Xcellerex process

development and production teams

FlexFactoryreg Platform

FlexFactory is a portable modular all-disposablesbioproduction train that eliminates conventional clean

room requirements and delivers new production capacityin less than 1 year vs 3-5 years 50-70 less capital

investment 50 lower operating costs and multi-drugproduction with simple modifications to

modular components

Process Development ampGMP Manufacturing Services

To help clients eliminate many of the risks involved withdeploying new bioprocessing capacity Xcellerex offers a

world-class suite of technical services PDMaxreg Process Development services ensure you get an optimized

process fast Xcellerex GMP biomanufacturing servicesallow instant access to FlexFactory capacity for

evaluation purposes or as a bridge until your ownFlexFactory operation is ready for launch

Co-Developed ampProprietary Molecules

Xcellerex is so passionate about the power of ourtechnology that we are working with partners to develop aportfolio of proprietary molecules enabled by t he Xcellerex

platform Sourced primarily through in-licensing theseprograms enable Xcellerex to demonstrate our conviction

in the FlexFactory model while also continuouslyenhancing our technology and expanding ourknowledge base for the benefit of customers

and partners

ABOUT XCELLEREXXcellerex offers a unique blend of bioprocess systems platform technology and services delivered by a team with deep

roots as biomanufacturing practitioners

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 salesxcellerexcom