US-based contract research organisation (CRO) Theorem Clinical Research has entered into an exclusive partnership with contract manufacturer Gallus BioPharmaceuticals to expand the companies’ global reach and accelerate the progress to market of biopharmaceutical products in development.
Under the arrangement, Gallus will provide process development as well as clinical and commercial supply of mammalian cell-based biopharmaceuticals to Theorem’s customers. In return, Theorem will offer contract research services to Gallus’ customers.According to the partners, the collaboration addresses current inefficiencies in the working relationship between clinical trial sponsors and service providers by helping to outsource the research, development and ultimate commercial production of products more seamlessly and cost-effectively.
Many of Theorem’s customers, especially those based in Asia, need manufacturing assistance in the US market, noted the CRO’s chief executive officer, John Potthoff.
Based in St. Louis, Missouri, Gallus was set up as a contract manufacturing organisation (CMO) in 2010 and acquired a commercial biopharmaceutical manufacturing facility and workforce from Johnson & Johnson’s Centocor division the next year.
Those assets, acquired with private equity backing, included more than 25 years’ experience in process development and a decade of commercial manufacturing. The St Louis site can support the development of early-phase processes through to scale-up and full clinical and commercial production.
Rebranded from Omnicare Clinical Research in June 2001, Theorem recently moved to new headquarters in King of Prussia, Pennsylvania to accommodate growth in its workforce and an expanded client base.