Xcellerex Announces Sale Of FlexFactory™ Bioproduction Line To Crucell For Vaccine, Monoclonal Antibody Manufacturing Facility
Xcellerex, Inc. announced recently that Crucell N.V. is acquiring a FlexFactory™ bioproduction line and multiple XDR single-use bioreactors, to rapidly expand the capacity and flexibility of its manufacturing capabilities. Crucell is the latest company to purchase a FlexFactory, Xcellerex's innovative, modular turnkey manufacturing platform. The project will deliver new, validated clinical manufacturing capacity at Crucell's operations in Leiden, The Netherlands during the first quarter of 2010, enabling Crucell to commence production years faster than with conventional technologies. Financial terms were not disclosed.
"The FlexFactory purchase is an important part of our product development strategy as we build capacity to support our growing pipeline of vaccines and therapeutic antibodies for infectious diseases," commented Dr. Cees de Jong, Chief Operating Officer at Crucell. "In addition to coming on line rapidly, the FlexFactory platform has great potential to increase our operational efficiency based on its flexibility for multi-drug production, use of disposables, and reduced operating expenses."
Xcellerex President and Chief Executive Officer Joseph Zakrzewski commented, "Crucell is the world's largest independent vaccine manufacturer and a growing infectious disease company. The company's FlexFactory purchase is a major endorsement of our manufacturing and development platform." He noted that Xcellerex has demonstrated the potential of its platform, producing nearly 20 biotherapeutics and vaccines for use in clinical trials over the past several years.
The FlexFactory is based on the innovative application of (1) single-use technologies; (2) controlled environmental modules (CEMs); and (3) advanced and proven process automation including electronic batch records. The FlexFactory effectively eliminates clean- and steam-in-place and clean room infrastructure, greatly simplifies facility design, reducing manufacturing footprint and capital investment, and creates breakthrough gains in operating efficiency, flexibility and environmental friendliness.
The agreement, which also includes the sale of Xcellerex's XDR single-use bioreactors, follows collaborative design work by the two companies over a period of several months. Xcellerex is also providing in-depth support and training services as well as contract manufacturing services to help accelerate Crucell's deployment efforts. The FlexFactory line will be assembled, tested, and operated at Xcellerex for protocol development and simultaneous operator training. Xcellerex may also complete engineering and/or GMP manufacturing runs for Crucell before TransPlanting™ the modular FlexFactory line to the Leiden facility for rapid site validation and start-up.
About Crucell, NV
Crucell N.V.is a global biopharmaceutical company focused on research development, production and marketing of vaccines, proteins and antibodies that prevent and/or treat infectious diseases. Its vaccines are sold in public and private markets worldwide. Crucell's core portfolio includes a vaccine against hepatitis B, a fully-liquid vaccine against five important childhood diseases and a virosome-adjuvanted vaccine against influenza. Crucell also markets travel vaccines, such as the only oral anti-typhoid vaccine, an oral cholera vaccine and the only aluminum-free hepatitis A vaccine on the market. The Company has a broad development pipeline, with several product candidates based on its unique PER.C6® production technology. The Company licenses its PER.C6® technology and other technologies to the biopharmaceutical industry. Important partners and licensees include DSM Biologics, sanofi-aventis, Novartis, Wyeth, GSK, CSL and Merck & Co. Crucell is headquartered in Leiden, the Netherlands, with subsidiaries in Switzerland, Spain, Italy, Sweden, Korea and the U.S. The Company employs over 1000 people. For more information, visit www.crucell.com.
About Xcellerex, Inc.
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 and services 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. For more information, visit www.xcellerex.com