Under the terms of the agreement, Therapure will be responsible for the manufacture of two major plasma proteins and LFB will remain responsible for global regulatory approvals and marketing of these products. Therapure will retrofit its Health Canada licensed manufacturing facility to accommodate the installation of LFB proprietary technology and processes necessary to meets its manufacturing obligations.
The companies expect the facility to be completed in 2011. Qualification and validation process, including regulatory batches will be performed in 2012, in order to complete the regulatory approval process in the course of 2013.
Thomas Wellner, president and CEO of Therapure, said: “We are proud to have been chosen by LFB as its contract manufacturer to support this important market expansion. We will be making a substantial investment in manufacturing capacity to meet LFB’s needs and to provide them with a more globally diversified and secure supply chain for these life-saving products.”
Christian Bechon, president and CEO of LFB, said: “Their commitment of time and capital to retrofit their Toronto, Canada facility has made us confident that Therapure will be well positioned to significantly contribute to the global expansion of LFB which include North America for added value proteins.”