Gallus Biopharmaceuticals, LLC Completes Initial $20 Million Expansion of Early-Phase Clinical Manufacturing Facility
Gallus’s new Clinical Services Suite (CSS) will operate under cGMP for Phase I, II and III clinical supply of monoclonal antibodies and recombinant proteins. The 8,000 square ft. facility is designed for mammalian-based manufacturing processes incorporating a 50 to 2,000L-scale Xcellerex® FlexFactory® with high-tech, single-use technology. Gallus has also doubled the size of its process development laboratories. This month marks the company’s first anniversary of leveraging the 25-year legacy of its commercially licensed facility in St. Louis, MO. Gallus has transformed the site (acquired from Centocor Biologics, LLC in 2011) from a large, world-class pharmaceutical facility to a stand-alone dynamic contract manufacturing organization (CMO). Gallus combines the strength of its large pharmaceutical legacy with the flexibility customers need from a premier CMO. In addition to the conventional “pay-per-run” approach, Gallus also offers its customers an innovative virtual ownership solution known as SuiteSPACETM. SuiteSPACETM is designed to allow customers an affordable alternative to building and running their own facility with all of the transparency, flexibility, confidence and assurance they expect from a world-class, globally licensed CMO.
“The expansion of single-use, disposable capacity at Gallus reflects the growing demand in the biopharmaceutical industry for a fast, cost-effective development and manufacturing solution,” commented Mark Bamforth, Gallus BioPharmaceuticals President and CEO.
Bamforth added, “The partnership with Xcellerex allows us to leverage their single-use biomanufacturing platform. This facility expansion is a strategic investment that rapidly addresses our customer’s needs for capacity and scale-up capabilities to deliver development, clinical and commercial products and services.”
About Gallus Biopharmaceuticals:
Gallus BioPharmaceuticals is a leading contract manufacturing company offering exceptional contract services to its clients. The firm is based in St. Louis, MO was established in 2010 and acquired a world-class commercial biopharmaceutical manufacturing facility and workforce from Johnson & Johnson/Centocor division in 2011. In addition to process development and clinical supply services, Gallus currently produces two commercial products which are distributed globally. The St. Louis facility has been inspected by every major regulatory body worldwide. For additional information on biopharmaceutical contract development and manufacturing services, http://www.gallusbiopharma.com or email info@gallusbiopharma.com or call directly at (314) 426 – 5000.