In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
|Articles|July 9, 2009
Crucell Purchases Xcellerex Bioproduction Line for Vaccine, MAb Manufacturing Facility
Author(s)BioPharm International Editors
Crucell N.V. (Leiden, the Netherlands) is acquiring a FlexFactory bioproduction line and multiple XDR single-use bioreactors from Xcellerex, Inc. (Marlborough, MA) to expand the capacity and flexibility of its manufacturing capabilities. The project will deliver validated clinical manufacturing capacity at Crucell?s operations during the first quarter of 2010, enabling Crucell to commence production years faster than with conventional technologies.
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Crucell N.V. (Leiden, the Netherlands) is acquiring a FlexFactory bioproduction line and multiple XDR single-use bioreactors from Xcellerex, Inc. (Marlborough, MA) to expand the capacity and flexibility of its manufacturing capabilities. The project will deliver validated clinical manufacturing capacity at Crucell’s operations during the first quarter of 2010, enabling Crucell to commence production years faster than with conventional technologies.
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 and 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.
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