Gallus Biopharmaceuticals Enters Clinical Supply Agreement with Genzyme
(St. Louis, Missouri, July 31, 2013) Gallus Biopharmaceuticals, LLC (Gallus) has signed a development and manufacturing supply agreement with Genzyme, a Sanofi Company the pioneer in the development and delivery of transformative therapies for patients with rare and special unmet medical needs for over 30 years. As part of the multi-year agreement Gallus will provide process and method development, scale-up, clinical supply and preparation for commercial manufacturing for an infused protein-based therapy targeting the rare disease, Niemann-Pick type B. “Gallus is delighted to partner with Genzyme in bringing this therapy to patients in need” said Mark Bamforth, Gallus’ CEO and President. “We are confident that our deep process development expertise and over ten years of commercial, perfusion-based biomanufacturing for global markets using proprietary, flexible stainless steel bioreactors will result in successful delivery of this therapeutic molecule to advance Genzyme’s clinical program.”
Niemann-Pick type B is caused by a deficiency of an enzyme called acid sphingomyelinase, which is required for the normal turnover of sphingomyelin, a major lipid of cell membranes. The enzyme deficiency causes sphingomyelin to accumulate in patients and leads to enlargement of the liver and spleen, lung disease, low blood cell counts and in some cases a shortened lifespan.
About Gallus BioPharmaceuticals
Gallus BioPharmaceuticals is a leading contract manufacturing company offering exceptional contract services to its clients. The firm, based in St. Louis, Missouri, was established in 2010 and acquired a world class commercial biopharmaceutical manufacturing facility from Johnson & Johnson’s Centocor division in 2011 and has grown its workforce by over 50% since then. In addition to process development and clinical supply services, Gallus currently produces two commercial products that are distributed globally. The St. Louis facility has been inspected and approved by every major regulatory body worldwide. For additional information on biopharmaceutical contract development and manufacturing services: