Xcellerex Introduces 10 Liter XDR-10 Single-Use Bioreactor
Fully integrated GMP system delivers complete process control upon delivery.
Xcellerex, Inc. announced recently that it has introduced the XDR-10, a new 10 liter version of its industry leading XDR line of single-use bioreactors. The XDR-10 joins an existing lineup that includes units with nominal working volumes of 50, 200, 500, 1,000 and 2,000 liters.
The XDR-10 shares the same robust design and vessel geometries as the larger XDR models, providing seamless linear scale-up from 10L to 2000L. The XDR-10 also features industrial-grade instrumentation and controls to deliver consistent process performance across the entire product family. Because the entire XDR line uses the same product contact materials, qualification is greatly simplified as a process is scaled-up. Primary application areas include process development, seed trains and production process modeling.
According to Xcellerex Product Manager for Bioreactors, Jiyoung Lee, "With the XDR-10, we can now offer biologics developers a seamless path from benchtop to production. The product line delivers linear scale-up across all volumes, allowing reliable, predictable results. Taking the step, from bench- to pilot-scale, just got less risky."
Adds Lee, "We gathered extensive marketplace input before designing this system, and we are confident that its combination of award-winning process controls and robust vessel design make the XDR-10 a unique productivity tool that has been missing from the single-use marketplace. Of course, the system also comes with the deep process knowledge of the Xcellerex team. Our early development partners have achieved process equivalence in their scale-up runs, both from flask to the XDR-10 and from the XDR-10 to production scales."
"Biopharm customers have enthusiastically embraced the XDR as the best fully-integrated, GMP single-use bioreactor available," said Ken Clapp, Senior Director, Global Marketing & Product Management at Xcellerex. "They have been eager to get their hands on a bench scale version of the system, and we believe they will be thrilled with this new product. The XDR-10 emphasizes our on-going commitment to define the future of biomanufacturing…now, starting at the benchtop."
Xcellerex will exhibit the XDR-10 at the BIO International Convention in Washington, DC on June 27-30 (booth 1541).
About Xcellerex, Inc.
Xcellerex is commercializing turnkey biomanufacturing solutions that transform the speed and economics of producing therapeutic proteins, including biosimilars and vaccines. The company's FlexFactory is a complete modular and portable production train based on single-use technologies, advanced process automation, and compact clean room architecture.
FlexFactory allows deployment of GMP manufacturing capacity more rapidly and at greatly reduced costs compared with traditional facilities. Through its BridgeSourcing™ services, Xcellerex manufactures a partner's biomolecules while the partner prepares for commissioning of its own new FlexFactory.
When the partner's facility is ready, Xcellerex deploys its TransPlant process to install, validate and train partner personnel in their own FlexFactory. This parallel-path model both accelerates time to clinical and commercial manufacturing and allows partners to manage the development and market risks associated with adding manufacturing capacity.
Xcellerex also leverages its proprietary single use technologies through the sale of XDR bioreactors, XDM Quad Mixers, and related single-use assemblies. To date, more than 20 therapeutic proteins and vaccines have been manufactured for clinical trials using Xcellerex technology.
Based in Marlborough, Massachusetts, Xcellerex is backed by an experienced management team and top-tier venture investors including Kleiner Perkins Caufield & Byers, VantagePoint Venture Partners and SCG Capital.