Xcellerex is revolutionizing the way biomolecules are developed, manufactured and commercialized. The company’s unique, single-use component technology platform transforms biomanufacturing economics, enabling the development of biotherapeutics and vaccines, and dramatically improving the ability of Xcellerex and its partners to deploy manufacturing capacity. Xcellerex leverages its technology platform by: 1) commercializing its FlexFactories™ (complete, turnkey, modular production trains) and XDR™ (unique, single use component bioreactor systems); 2) building a portfolio of proprietary biotherapeutics and vaccines through creative alliances and in licensing; and 3) creatively structuring transactions around FlexFactories, XDRs and its pipeline.

Products and Technologies:

FlexFactory™ Biomanufacturing Platform

FlexFactory is a bioprocess manufacturing platform built almost exclusively around disposables technology. Each unit operation within the FlexFactory is self-contained in its own controlled environment module (CEM), thereby eliminating the need for expensive clean-room facilities. FlexFactory is the only biomanufacturing platform that delivers the speed and capital efficiency of the CMO approach with the control and long-term economics of company-controlled manufacturing. FlexFactory specifically impacts biomanufacturing strategy in several fundamental ways, by reducing capital investment (50 percent or more); time to production (12-18 months vs. 3-5 years); and water consumption (70 percent), and increasing flexibility for multi-drug production and enabling the biomanufacturing operation to be TransPlanted to the customer site.

XDR™ Single Use Bioreactors

XDR Single-Use Bioreactors from Xcellerex are fully-integrated systems designed for GMP clinical and commercial production. XDR systems are available with working volumes of 200, 500, 1,000 and 2,000 liters. Xcellerex delivers the XDR as a fully-integrated, fully- characterized system that performs to customer expectations upon delivery. Start-up testing and programming are effectively non-existent. The XDR bioreactor also is the engine of the Xcellerex biomanufacturing operation and the heart of the FlexFactory™ platform. The Xcellerex production team has used the XDR to test, optimize and run a wide range of cell lines including CHO, hybridoma, human, and insect cells.

XDM™ Single Use Mixing Systems

Xcellerex XDM Single-Use Mixing systems are designed for fast, convenient preparation of buffers, media and other aqueous solutions. The XDM features irradiated single-use LDPE bags, eliminating the need for CIP/SIP and cleaning validation. Turnover time between batches takes only minutes. XDM's magnetically-locked impeller drive system delivers high-torque mixing unmatched in other disposable systems. Even highly viscous solutions (1,000 CP) can be 100% mixed in less than 90 minutes. Less viscous solutions can be thoroughly mixed in seconds.

XDA™ Disposable Assembly

Xcellerex bioreactors and mixing systems feature the XDA disposable, single-use product contact assembly. These units include all gas filters, agitation system components, sparge components, probes, ports, pressure sensors, sampling ports, and gas and liquid transfer tubes. The magnetically coupled internally mounted agitator requires no rotating seals or shaft penetrations through disposable assembly. Installation and connections take just minutes. The materials used in XDA are regularly used in biopharmaceutical processing applications.

Xcellerex Services

Xcellerex supports its FlexFactory™ platform and XDR™ single-use bioreactors with an unrivaled suite of expert process development and manufacturing services. The company provides services, including PDMax™ Process Development and Optimization and biomanufacturing, to help clients manage timing and investment risk for access to the FlexFactory™ platform and XDR™ single-use bioreactors.

Business Model

The company’s business model is to capitalize on its technology and services platform to: commercialize the FlexFactory and XDR bioreactors with pharmaceutical and biotechnology companies; develop a pipeline of proprietary biomolecules, including biotherapeutics and vaccines; enter creative alliances to build its pipeline and commercialize FlexFactories and XDR bioreactors.

Management:

Joe Zakrzewski, Chief Executive Officer
Parrish Galliher, Founder, President and Chief Technology Officer
John Chickosky, Chief Operating Officer
Bob Morgan, Chief Financial Officer

Last Updated: 02-28-2008