XDR ™ Disposable Bioreactor Overview XDR Disposable Bioreactors from Xcellerex are fully-integrated systems that deliver proven stirred-tank performance that closely tracks conventional stainless steel systems. Every day, the XDR is proven by Xcellerex’s in-house process development and GMP contract manu- facturing operations. Our production team has tested, optimized and run a wide range of cell lines including CHO, hybridoma, human, and insect cells. Our process know-how and XDR’s unique design make it the only disposables-based bioreactor that delivers process control better than conven- tional systems. But unlike conventional systems, new XDRs can be delivered in less than 12 weeks from order date and fully operational in hours. Key XDR Features • Jacketed kettle supporting 5-1 turndown • Batch-to-Batch changeover in less than 1 hour • Complete turn-key GMP-ready system • Quality Certificate of Compliance • Powerful magnetic drive agitation • No rotating seals • Highly optimized standard configuration • Integrated temperature control • Plug & Play hookup • Small footprint • No CIP/SIP required XDR single-use bioreactor systems are available with maximum working volumes of 200L (XDR-200), 500L (XDR-500), 1,000L (XDR-1000) and 2,000L (XDR-2000). www.xcellerex.com • 1-866-Xcellerex XDR delivers comparable performance in both growth rate (cell expansion phase) and maximum cell density, key indicators that the XDR is performing with no unique process sensitivity exhibited (such as interfacial or hydrodynamic shear which would show as a reduced “apparent” growth rate). Note also that the Max VCD is high for this process (1.3E7). XDR delivers comparable performance to stainless steel Viable Cell Density (cells/mL) 0.00E+00 2.00E+06 4.00E+06 6.00E+06 8.00E+06 1.00E+07 1.20E+07 1.40E+07 1.60E+07 1.80E+07 2.00E+07 -150.0 -100.0 -50.0 0.0 50.0 100.0 150.0 200.0 250.0 300.0 3000L eng GMP1 GMP2 GMP3 XDR-200 XDR-200-2
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XDR™ Disposable Bioreactor
OverviewXDR Disposable Bioreactors from Xcellerex are
fully-integrated systems that deliver proven
stirred-tank performance that closely tracks
conventional stainless steel systems. Every
day, the XDR is proven by Xcellerex’s in-house
process development and GMP contract manu-
facturing operations. Our production team has
tested, optimized and run a wide range of cell
lines including CHO, hybridoma, human, and
insect cells.
Our process know-how and XDR’s unique design
make it the only disposables-based bioreactor
that delivers process control better than conven-
tional systems. But unlike conventional systems,
new XDRs can be delivered in less than 12 weeks
from order date and fully operational in hours.
Key XDR Features
• Jacketed kettle supporting 5-1 turndown
• Batch-to-Batch changeover in less than 1 hour
• Complete turn-key GMP-ready system
• Quality Certificate of Compliance
• Powerful magnetic drive agitation
• No rotating seals
• Highly optimized standard configuration
• Integrated temperature control
• Plug & Play hookup
• Small footprint
• No CIP/SIP required
XDR single-use bioreactor systems are available with maximum working volumes of 200L (XDR-200), 500L (XDR-500), 1,000L (XDR-1000) and 2,000L (XDR-2000).
www.xcellerex.com • 1-866-Xcellerex
XDR delivers comparable performance in both growth rate (cell expansion phase) and maximum cell density, key indicators that the XDR is performing with no unique process sensitivity exhibited (such as interfacial or hydrodynamic shear which would show as a reduced “apparent” growth rate). Note also that the Max VCD is high for this process (1.3E7).
XDR delivers comparable performance to stainless steel
XDR DETAILSThe Xcellerex Disposable Bioreactor System is a fully integrated bioreactor capable of growing mammalian cellcultures and low density microbial fermentations.
INTEGRATED COMPONENTS INCLUDE:
XDA™ PRO Series Disposable AssemblyDisposable, single-use product contact assembly includes all gas filters, agitation system, sparge, probes, ports, pressure sensors sampling, and gas and liquid transfer tubes. Magnetically coupled internally-mounted agitator requires no rotating seals or shaft penetrations through disposable assembly. Installation takes minutes.
Tank HardwareCustomized jacketed stainless steel tank designed to sup-port and facilitate disposable bag loading and 5:1 turndown capability function and provide integrated control system interface.
Temperature ControllerClosed loop Controller for rapid heating and cooling does not require building utilities.
Control System & Operator InterfaceDelta V® or PLC control system available. Both optimized to deliver rigorous control performance with XDA PRO Series disposable assembly.
XDR XDR XDR XDRVolume Type 200 500 1000 2000Nominal 260 L 560 L 1100 L 2200LWorking* 200 L 500 L 1000 L 2000LMinimal Working 40 L 100 L 200 L 400L
* Each system maintains a 1.5:1 height-to-diameter working volume ratio.
COMPLIANCE AND QUALITY ATTRIBUTES
Product Contact Materials Controller / Data CollectionUSP Class VI 21 CFR Part 11 CompliantNon-Cytotoxic Fully ConfigurableGamma Irradiated Full Audit Trail
