xdr bioreactor brochure4
XDR Series
GMP Single-Use Bioreactors
Fully integrated systems with advanced process control . for unmatched productivity
.
XDR Series GMP Single-Use Bioreactors Productivity that matches or exceeds stainless steel systems with the convenience of a fully integrated single-use platform
Xcellerex XDR Single-Use Bioreactors are fully integrated stirred-tank systems that outperform any bioreactor... stainless or disposable. But XDR systems also come with something no other bioreactor maker can match: The Xcellerex team. With years of experience running GMP biomanufacturing operations, Xcellerex designed the XDR system for scalability and to deliver complete process control from the moment you start-up your system. And with Xcellerex’s in-house process optimization and biomanufacturing teams running XDRs every day, you can draw on our vast body of data and experience to be sure to get your process right the first time and to keep it running successfully.
Scalable capacity from development to GMP production XDR bioreactors are available with working volumes of 40 Liters to 2,000 Liters. The systems were designed as true stirred-tanks for scalability and have been extensively characterized to deliver consistent, predictable performance across the full spectrum of applications. (XDR-1000 not shown)
XDR-200
XDR-500
XDR-2000
Make product while others are still making plans The XDR is unmatched in integration and characterization among disposable systems. With the XDR, you spend months making product at your process performance specifications while others are investing manpower and valuable materials to integrate their disposable bioreactors. And XDRs are real-world tested and proven: cGMP product made in the XDR is currently being used in clinical trials under INDs filed with the FDA. So whether you’ve already committed to single-use systems or are considering a switch from traditional stainless steel, Xcellerex invites you to discover how the robust performance and control of an XDR bioreactor can be yours in 12 weeks or less.
Eliminate the complexity,
Product contact in XDR bioreactors is limited to sterile single-use components, eliminating the need for clean-in-place/steam-in-place operations and the expensive and complex infrastructure they require.
risk & expense of traditional
u Eliminate the risk of cross-contamination
stainless steel systems
u Significantly reduce batch-to-batch turnaround time u Reduce annual operating costs by 35%
1.866.Xcellerex
u Reduce installed-system capital expense by 75% u Accelerate time to start-up by 10 months or more
Fully integrated for fast start-up u
Fully-integrated vessel and process control unit create a process-ready system upon delivery
u
All XDRs are factory acceptance tested prior to delivery
u
True plug-and-play performance: Connect gases and electric power and get started
u
Delivered and operational in 12 weeks or less
Unmatched system performance and versatility u
5:1 turndown means one XDR can operate at 20% volume, doing the work of multiple reactors
u
Enhanced sparge control and CO2 stripping enables productivity gains not possible with other systems
u
Robust, self-installing magnetically-driven bottom-mount impeller: Eliminates rotating seals, insertable shafts and connection hassles
u
Integrated heating and cooling with jacketed vessel delivers efficient temperature regulation throughout scale-up
Expert know-how only from Xcellerex u
Xcellerex process experience and know-how is built-into every XDR: Your process is up and running right the first time
u
Expert technical service team supports you and your process, ensures reliability
u
Xcellerex process development team helps optimize your process and prepare for scale-up
u
Multiple sources for disposable components ensures your process security
Xcellerex: A unique partner in innovation Xcellerex is leading the charge in the single-use biomanufacturing revolution. To facilitate implementation of our innovative technology, Xcellerex offers a world-class suite of services that includes high-throughput process development, media optimization, proof of concept runs, and GMP manufacturing on the FlexFactory™ platform. Our unique blend of offerings enables Xcellerex to partner with other biotechnology companies like no other in the industry. Please see the rear panel of this brochure for a more complete snapshot.
www.xcellerex.com
Xcellerex, Inc. Revolutionizing the way biomolecules are developed, manufactured and commercialized
Single-Use Bioreactors & Mixers
FlexFactory™ Platform
Xcellerex single-use GMP bioreactors systems outperform other disposables-based systems and traditional stainless steel systems on the first run and every run. Unlike other bioreactors, Xcellerex systems are fully integrated, including a vessel, control unit and the knowledge base that comes with the Xcellerex process development and production teams.
FlexFactory is a portable, modular, all-disposables bioproduction train that eliminates conventional cleanroom requirements and delivers new production capacity in 1 year vs. 3-5 years; 50%-70% less capital investment; 50% lower operating costs; and multi-drug production with simple modifications to modular components.
Co-Developed & Proprietary Molecules
Process Development & GMP Manufacturing Services
Xcellerex is so passionate about the power of our technology that we are working with partners to develop a portfolio of proprietary molecules enabled by the Xcellerex platform. Sourced primarily through in-licensing, these programs enable Xcellerex to demonstrate our conviction in the FlexFactory model while also continuously enhancing our technology and expanding our knowledge base for the benefit of customers and partners.
To help clients eliminate many of the risks involved with deploying new bioprocessing capacity, Xcellerex offers a world-class suite of technical services. PDMax™ Process Development services ensure you get an optimized process fast. Xcellerex GMP biomanufacturing services allow instant access to FlexFactory capacity for evaluation purposes or as a bridge until your own FlexFactory operation is ready for launch.
Xcellerex, Inc. 170 Locke Drive Marlborough, Massachusetts 01752 USA
1.866.Xcellerex (866.923.5537) 1.508.480.9235
www.xcellerex.com
1.866.Xcellerex
GMP Single-Use Bioreactors
Fully integrated systems with advanced process control . for unmatched productivity
.
XDR Series GMP Single-Use Bioreactors Productivity that matches or exceeds stainless steel systems with the convenience of a fully integrated single-use platform
Xcellerex XDR Single-Use Bioreactors are fully integrated stirred-tank systems that outperform any bioreactor... stainless or disposable. But XDR systems also come with something no other bioreactor maker can match: The Xcellerex team. With years of experience running GMP biomanufacturing operations, Xcellerex designed the XDR system for scalability and to deliver complete process control from the moment you start-up your system. And with Xcellerex’s in-house process optimization and biomanufacturing teams running XDRs every day, you can draw on our vast body of data and experience to be sure to get your process right the first time and to keep it running successfully.
Scalable capacity from development to GMP production XDR bioreactors are available with working volumes of 40 Liters to 2,000 Liters. The systems were designed as true stirred-tanks for scalability and have been extensively characterized to deliver consistent, predictable performance across the full spectrum of applications. (XDR-1000 not shown)
XDR-200
XDR-500
XDR-2000
Make product while others are still making plans The XDR is unmatched in integration and characterization among disposable systems. With the XDR, you spend months making product at your process performance specifications while others are investing manpower and valuable materials to integrate their disposable bioreactors. And XDRs are real-world tested and proven: cGMP product made in the XDR is currently being used in clinical trials under INDs filed with the FDA. So whether you’ve already committed to single-use systems or are considering a switch from traditional stainless steel, Xcellerex invites you to discover how the robust performance and control of an XDR bioreactor can be yours in 12 weeks or less.
Eliminate the complexity,
Product contact in XDR bioreactors is limited to sterile single-use components, eliminating the need for clean-in-place/steam-in-place operations and the expensive and complex infrastructure they require.
risk & expense of traditional
u Eliminate the risk of cross-contamination
stainless steel systems
u Significantly reduce batch-to-batch turnaround time u Reduce annual operating costs by 35%
1.866.Xcellerex
u Reduce installed-system capital expense by 75% u Accelerate time to start-up by 10 months or more
Fully integrated for fast start-up u
Fully-integrated vessel and process control unit create a process-ready system upon delivery
u
All XDRs are factory acceptance tested prior to delivery
u
True plug-and-play performance: Connect gases and electric power and get started
u
Delivered and operational in 12 weeks or less
Unmatched system performance and versatility u
5:1 turndown means one XDR can operate at 20% volume, doing the work of multiple reactors
u
Enhanced sparge control and CO2 stripping enables productivity gains not possible with other systems
u
Robust, self-installing magnetically-driven bottom-mount impeller: Eliminates rotating seals, insertable shafts and connection hassles
u
Integrated heating and cooling with jacketed vessel delivers efficient temperature regulation throughout scale-up
Expert know-how only from Xcellerex u
Xcellerex process experience and know-how is built-into every XDR: Your process is up and running right the first time
u
Expert technical service team supports you and your process, ensures reliability
u
Xcellerex process development team helps optimize your process and prepare for scale-up
u
Multiple sources for disposable components ensures your process security
Xcellerex: A unique partner in innovation Xcellerex is leading the charge in the single-use biomanufacturing revolution. To facilitate implementation of our innovative technology, Xcellerex offers a world-class suite of services that includes high-throughput process development, media optimization, proof of concept runs, and GMP manufacturing on the FlexFactory™ platform. Our unique blend of offerings enables Xcellerex to partner with other biotechnology companies like no other in the industry. Please see the rear panel of this brochure for a more complete snapshot.
www.xcellerex.com
Xcellerex, Inc. Revolutionizing the way biomolecules are developed, manufactured and commercialized
Single-Use Bioreactors & Mixers
FlexFactory™ Platform
Xcellerex single-use GMP bioreactors systems outperform other disposables-based systems and traditional stainless steel systems on the first run and every run. Unlike other bioreactors, Xcellerex systems are fully integrated, including a vessel, control unit and the knowledge base that comes with the Xcellerex process development and production teams.
FlexFactory is a portable, modular, all-disposables bioproduction train that eliminates conventional cleanroom requirements and delivers new production capacity in 1 year vs. 3-5 years; 50%-70% less capital investment; 50% lower operating costs; and multi-drug production with simple modifications to modular components.
Co-Developed & Proprietary Molecules
Process Development & GMP Manufacturing Services
Xcellerex is so passionate about the power of our technology that we are working with partners to develop a portfolio of proprietary molecules enabled by the Xcellerex platform. Sourced primarily through in-licensing, these programs enable Xcellerex to demonstrate our conviction in the FlexFactory model while also continuously enhancing our technology and expanding our knowledge base for the benefit of customers and partners.
To help clients eliminate many of the risks involved with deploying new bioprocessing capacity, Xcellerex offers a world-class suite of technical services. PDMax™ Process Development services ensure you get an optimized process fast. Xcellerex GMP biomanufacturing services allow instant access to FlexFactory capacity for evaluation purposes or as a bridge until your own FlexFactory operation is ready for launch.
Xcellerex, Inc. 170 Locke Drive Marlborough, Massachusetts 01752 USA
1.866.Xcellerex (866.923.5537) 1.508.480.9235
www.xcellerex.com
1.866.Xcellerex
