2,000 Liter Single-Use Bioreactor Added To Xcellerex XDR Platform Offerings
Fully integrated GMP system delivers complete process control upon delivery.
Marlborough, MA - Xcellerex, Inc. announced that it has introduced the XDR-2000, a 2000 liter version of its industry leading XDR line of single-use bioreactors. The XDR-2000 joins an existing lineup that includes units with nominal working volumes of 200, 500 and 1,000 liters.
"Biopharm customers have enthusiastically embraced the XDR as the best fully-integrated, GMP single-use bioreactor available," said John Chickosky, Chief Operating Officer at Xcellerex. "They have been clamoring for a unit that can support late clinical and commercial scale production, and we are pleased to deliver it ahead of schedule. This is a great option for anyone considering other disposables-based systems or considering a switch from traditional stainless steel bioreactors."
Adds Chickosky, "The XDR bioreactor platform delivers a level of process confidence that is unmatched in the disposables industry. Xcellerex has its roots in biomanufacturing and we were able to apply this process know-how to design a system that can hit customer performance targets, typically on the first run. This performance has proven scalable up and down the XDR line."
The XDR system features a fully integrated vessel and process control unit. Every XDR is factory acceptance tested (FAT) and commissioned prior to delivery, so that it arrives process-ready at the customer facility.
"It may seem unbelievable for a system as sophisticated as the XDR, but all a customer truly needs to do is plug in gas, power, and minimal utilities and the XDR is ready to go. The system is so well characterized that by uploading the customer's process parameters prior to delivery, the XDR can typically achieve better than 80% of target performance on the very first run," said Matt Niloff, Sr. Director of Products & Sales at Xcellerex.
Like all XDR systems, the XDR-2000 features a 5:1 turndown ratio, which means the system can operate at 20% nominal volume. This means the XDR-2000 can run batches from 400L to 2,000L. Adds Niloff, "The 5:1 turndown ratio adds tremendous flexibility to the system, as well as added economic savings. A customer can entirely eliminate the need to purchase one or more additional smaller seed reactors and instead use the XDR for multiple process steps."
According to Niloff, "The achievements of the XDR have not been overly publicized, but people should know that cGMP product made in the XDR is currently being used in clinical trials under INDs filed with the FDA. In addition, the system has been proven to perform for more complex perfusion processes at production scale. Plus, our in-house process optimization and biomanufacturing teams at Xcellerex are running these systems every day, so customers are sure to get the best process insight and support. We are extremely proud of the 2,000L XDR and are very excited by the opportunity to provide the industry with a fully-integrated, fully-scalable range of disposable bioreactors."
Other important XDR features include:
- Delivery of the turn-key system in twelve weeks or less.
- Robust, self-installing magnetically-driven bottom-mount impeller eliminates rotating seals, insertable shafts and connection hassles.
- Integrated heating and cooling with jacketed vessel delivers efficient temperature regulation throughout scale-up.
- No CIP/SIP means faster batch-to-batch turnaround, no cleaning validation and reduced operating costs
Xcellerex will be exhibiting the XDR at Interphex in Philadelphia, March 26-28 (Booth 2268).