Strategic alliance formed for cGMP clinical biomanufacturing

Montreal, QC – Laborium Biopharma and the Biotechnology Research Institute of the National Research Council (BRI-NRC) say they have concluded a strategic alliance to offer various complementary services for manufacturing and packaging clinical lots of biological products under the stringent good manufacturing practices (cGMP). This partnership will also include the setting up of a specialized training profile as well as a joint R&D program for developing and improving biomanufacturing methods.

Moreover, the two have signed a collaboration agreement that they say should lead to the purchase of a parcel of land that belongs to the NRC at the 6100 Royalmount Avenue in Montral, and where are currently located the BRI-NRC facilities.

“Such an increased and integrated presence within the industrial biomanufacturing sector of the Montral Metropolitan area will markedly enhance the international visibility and synergies within the emerging biotechnology and biomanufacturing cluster of the Montral area,” says Luc Dubois, president of Laborium Biopharma. “Furthermore, it will also improve the attractiveness of potential foreign investors, thus resulting in positive impacts for this region’s biotechnology and biomanufacturing cluster."

The alliance between Laborium and the BRI-NRC is taking place in the context of a biopharmaceutical contract manufacturing organizations (CMO) global market growing at 15-20% annually. At the present time, large international players such as DSM Biologics, whose main facilities are adjacent to the BRI-NRC site, are focusing on the biomanufacturing of commercial large-scale lots of biological products. However, a lack of specialized industrial capacity for biomanufacturing preclinical and clinical lots, at both the national and international scale, is creating business opportunities.

This partnership will perfectly fit within the strategic initiative of building up an integrated cGMP biomanufacturing and training center that will be designed around the BRI-NRC expertise and activities. This initiative will enable the partners to efficiently cover the complete value chain of biomanufacturing, and will add highly practical aspects to the training profile of a specialized biomanufacturing workforce.

When the necessary funding is obtained, Laborium will also be in charge of constructing a cGMP pilot plant for manufacturing preclinical to clinical lots of biological products. The construction is scheduled to start next spring, and the complete Laborium project will require a financing of about $40 million. Also, BRI-NRC is planning to develop and build a practical training centre and additional R&D facilities that will work in synergy with the innovation capacity of present and future industrial partners.