White Paper: 8 Questions To Ask Before Planning Your Single-Use Biomanufacturing Facility In this paper, we examine eight critical considerations facing the biopharmaceutical and vaccine production landscape, and how each is addressed with this new, proven approach to biomanufacturing.

Revolutionizing the way biomolecules are developed, manufactured and commercialized

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 is focused on three major strategic activities:

• Commercializing its FlexFactory™ platform and XDR™ bioreactor systems
• Building a portfolio of proprietary biotherapeutics and vaccines through creative alliances and in-licensing
• Creatively structuring transactions around FlexFactories, XDRs and its pipeline

The Xcellerex Solution
Xcellerex is commercializing a highly innovative manufacturing technology platform, based on proprietary, single-use bioprocess systems technology that drastically improves the overall economics of biomolecule development. The platform is built around the FlexFactory™, the first, complete turnkey, modular production train which includes the XDR™ disposable bioreactor system with demonstrated performance comparable to traditional stainless systems up to 2,000 liters. FlexFactory™ combines the sophisticated control and process capability of traditional manufacturing with the simplicity of Xcellerex's novel disposable platform and capabilities.

The technology platform allows manufacturing capacity to be deployed rapidly, flexibly and at greatly reduced cost compared with conventional technology.

For example, fullyintegrated manufacturing capacity can be established within one year vs. three-to-five years at a capital reduction of 50 percent to 75 percent compared with traditional facilities.

Proof of Concept
To meet a clinical timeline, Xcellerex designed, constructed, installed, and validated an entire FlexFactory™ system in less than six months, enabling production of cGMP material and launch of a clinical trial less than one year from project initiation. The total capital cost was less than 50% of a comparable traditional facility.

Management and Organization
Xcellerex has built a management team with world class expertise in biologics manufacturing and outstanding track records in growing life science organizations.

Joe Zakrzweski, CEO, brings a wide range of commercial, corporate and business development experience from a 20-year career at Eli Lilly and Reliant Pharmaceuticals.

Parrish Galliher, President and Chief Technology Officer, founded Xcellerex in 2002 after an extensive career that included positions as head of manufacturing at Biogen and Millennium Pharmaceuticals.

Click to see what was new with Xcellerex - At INTERPHEX New York 2010! Xcellerex - At INTERPHEX New York 2010, Parrish Galliher from Xcellerex, Inc. announces the new Flex Factory manufacturing system designed to provide a total solution to biomanufacturing for biosimilars, vaccines, and biotherapeutics. Flex Factory consists of disposables integrated with the flexibility of modular, collapsed small environments and the online precision of tracking quality of manufacturing. Flex Factory reduces capital costs by over 50%, operating costs by 30%, and the plant footprint by almost 40% compared to traditional technologies.