XDR⢠Disposable Bioreactor
XDR⢠Disposable Bioreactor
XDR⢠Disposable Bioreactor
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
XDR <strong>Disposable</strong> <strong>Bioreactor</strong><br />
Overview<br />
XDR <strong>Disposable</strong> <strong>Bioreactor</strong>s from Xcellerex are<br />
fully-integrated systems that deliver proven<br />
stirred-tank performance that closely tracks<br />
conventional stainless steel systems. Every<br />
day, the XDR is proven by Xcellerex’s in-house<br />
process development and GMP contract manufacturing<br />
operations. Our production team has<br />
tested, optimized and run a wide range of cell<br />
lines including CHO, hybridoma, human, and<br />
insect cells.<br />
Our process know-how and XDR’s unique design<br />
make it the only disposables-based bioreactor<br />
that delivers process control better than conventional<br />
systems. But unlike conventional systems,<br />
new XDRs can be delivered in less than 12 weeks<br />
from order date and fully operational in hours.<br />
Key XDR Features<br />
• Jacketed kettle supporting 5-1 turndown<br />
• Batch-to-Batch changeover in less<br />
than 1 hour<br />
• Complete turn-key GMP-ready system<br />
• Quality Certificate of Compliance<br />
• Powerful magnetic drive agitation<br />
• No rotating seals<br />
• Highly optimized standard configuration<br />
XDR single-use bioreactor systems are available with maximum working<br />
volumes of 200L (XDR-200), 500L (XDR-500), 1,000L (XDR-1000) and 2,000L<br />
(XDR-2000).<br />
XDR delivers comparable performance to stainless steel<br />
Viable Cell Density (cells/mL)<br />
2.00E+07<br />
1.80E+07<br />
1.60E+07<br />
1.40E+07<br />
1.20E+07<br />
1.00E+07<br />
8.00E+06<br />
6.00E+06<br />
4.00E+06<br />
2.00E+06<br />
3000L eng<br />
GMP1<br />
GMP2<br />
GMP3<br />
XDR-200<br />
XDR-200-2<br />
0.00E+00<br />
-150.0 -100.0 -50.0 0.0 50.0 100.0 150.0 200.0 250.0 300.0<br />
XDR delivers comparable performance in both growth rate (cell expansion phase) and maximum cell<br />
density, key indicators that the XDR is performing with no unique process sensitivity exhibited (such as<br />
interfacial or hydrodynamic shear which would show as a reduced “apparent” growth rate). Note also<br />
that the Max VCD is high for this process (1.3E7).<br />
• Integrated temperature control<br />
• Plug & Play hookup<br />
• Small footprint<br />
• No CIP/SIP required<br />
Indianapolis ● Chicago ● San Juan<br />
www.hollandapt.com<br />
800-800-8464<br />
www.xcellerex.com • 1-866-Xcellerex
XDR DETAILS<br />
The Xcellerex <strong>Disposable</strong> <strong>Bioreactor</strong> System is a fully<br />
integrated bioreactor capable of growing mammalian cell<br />
cultures and low density microbial fermentations.<br />
INTEGRATED COMPONENTS INCLUDE:<br />
XDA PRO Series <strong>Disposable</strong> Assembly<br />
<strong>Disposable</strong>, single-use product contact assembly includes all<br />
gas filters, agitation system, sparge, probes, ports, pressure<br />
sensors sampling, and gas and liquid transfer tubes.<br />
Magnetically coupled internally-mounted agitator requires<br />
no rotating seals or shaft penetrations through disposable<br />
assembly. Installation takes minutes.<br />
Tank Hardware<br />
Customized jacketed stainless steel tank designed to support<br />
and facilitate disposable bag loading and 5:1 turndown<br />
capability function and provide integrated control system<br />
interface.<br />
Temperature Controller<br />
Closed loop Controller for rapid heating and cooling does<br />
not require building utilities.<br />
Control System & Operator Interface<br />
Delta V ® or PLC control system available. Both optimized to<br />
deliver rigorous control performance with XDA PRO Series<br />
disposable assembly.<br />
Utility Requirements<br />
Process gases and 230V, 3 phase, 60 hz<br />
(EU: 380V, 3 phase, 50 hz)<br />
CE certified units available for EU customers.<br />
SYSTEM VOLUMES<br />
XDR XDR XDR XDR<br />
Volume Type 200 500 1000 2000<br />
Nominal 260 L 560 L 1100 L 2200L<br />
Working* 200 L 500 L 1000 L 2000L<br />
Minimal Working 40 L 100 L 200 L 400L<br />
* Each system maintains a 1.5:1 height-to-diameter working volume ratio.<br />
COMPLIANCE AND QUALITY ATTRIBUTES<br />
Product Contact Materials<br />
USP Class VI<br />
Non-Cytotoxic<br />
Gamma Irradiated<br />
CONTROL LOOPS<br />
Configured and Tuned at Operator Interface<br />
Controller / Data Collection<br />
21 CFR Part 11 Compliant<br />
Fully Configurable<br />
Full Audit Trail<br />
Temperature 4°C – 75°C<br />
pH 2 - 12<br />
Pump Metering<br />
0 - 2.0 SLPM<br />
Agitator Speed<br />
0 - 350 RPM<br />
Dissolved Oxygen 0 - 100%<br />
Sparge/Headsweep Gases N2, O2, CO2, Air<br />
Sparge Gas Flowrates<br />
0 - 20 SLPM<br />
Weight Control<br />
0- 1100 kg<br />
Headsweep Gas Flowrates 0 - 20 SLPM<br />
Exhaust Filter Temperature Ambient - 75 °C<br />
<strong>Disposable</strong> Pressure<br />
0.0 – 2.0 psig<br />
XDR delivers comparable productivity<br />
XDR delivers comparable cell viability<br />
1.5<br />
3000L eng<br />
120<br />
1.3<br />
GMP1<br />
1.1<br />
GMP2<br />
GMP3<br />
100<br />
Titer (mg/mL)<br />
0.9<br />
0.7<br />
0.5<br />
300L<br />
XDR200<br />
XDR200-2<br />
% Viability<br />
80<br />
60<br />
40<br />
3000L eng<br />
GMP1<br />
GMP2<br />
0.3<br />
GMP3<br />
0.1<br />
20<br />
XDR-200<br />
XDR-200-2<br />
-0.1<br />
120 144 168 192 216 240 264 288 312<br />
Age (hrs)<br />
The product titer and cellular productivity in the XDR closely match<br />
performance in stainless steel vessels.<br />
0<br />
-150.0 -100.0 -50.0 0.0 50.0 100.0 150.0 200.0 250.0 300.0<br />
XDR cell viability data aligns with GMP processes in stainless<br />
steel equipment.<br />
tm<br />
Xcellerex, Inc.<br />
Toll Free: 1-866-Xcellerex<br />
170 Locke Drive Tel: 508-480-9235<br />
Marlborough, MA 01752<br />
info@xcellerex.com<br />
USA<br />
www.xcellerex.com<br />
v.XDR041408<br />
Indianapolis ● Chicago ● San Juan<br />
www.hollandapt.com<br />
800-800-8464
Change language