Xcellerex and Itero Biopharmaceuticals in manufacturing and supply collaboration
US firms Xcellerex and Itero Biopharmaceuticals are to collaborate on the production of Itero's lead product. Xcellerex will provide development expertise and product manufacturing for clinical and commercial supplies of an undisclosed therapeutic protein.
US firms Xcellerex and Itero Biopharmaceuticals are to collaborate on the production of Itero's lead product. Xcellerex will provide development expertise and product manufacturing for clinical and commercial supplies of an undisclosed therapeutic protein.
San Mateo-based Itero has signed a master services agreement with Xcellerex of Marlborough, Mass.
The companies anticipate that this will be a multi-product collaboration and, for the first product, Xcellerex will manufacture Itero's Phase III clinical materials in 2010/2011.
Xcellerex's PDMax process development technology will be used to scale-up the manufacturing process in Xcellerex's FlexFactory and rapidly produce material to initiate clinical trials.
Financial terms were not disclosed, but contract manufacturing fees, as well as Itero equity, are being granted to Xcellerex.
FlexFactory is based on the application of single-use technologies, controlled environmental modules and advanced process automation including electronic batch records. The company says it effectively eliminates clean- and steam-in-place and cleanroom infrastructure, simplifies facility design and improves operating efficiency and flexibility.
"We believe we will provide a significant advantage to Itero in terms of cost, flexibility and control of its manufacturing destiny," said Joseph Zakrzewski, chief executive of Xcellerex.