Theorem Clinical Research and Gallus BioPharmaceuticals have entered an exclusive partnership under which Gallus will provide process development and clinical and commercial supply for mammalian cell-based biopharmaceutical products to Theorem’s customers, and Theorem will offer contract research services to Gallus’ customers. The collaboration aims increase both companies’ global reach and accelerate their customers’ products through the clinic to market.
Theorem provides CRO services for Phases I to IV, with niche business units in the areas of clinical analytics, medical device and pharmaceutics. Gallus provides process development and commercial manufacturing to support the development of early-phase processes through scale-up and full clinical and commercial production from its commercially licensed manufacturing site in St. Louis.
“Our intent is to make the process as seamless as possible,” said Gallus president and chief executive officer Mark Bamforth. “With our new collaboration with Theorem, we’ll be able to expand our portfolio of high-quality services to meet more of the comprehensive demands of our customers.”
Theorem chief executive officer John Potthoff said, “Many of Theorem’s customers, especially those in Asia, need manufacturing assistance in the U.S. market. Theorem’s partnership with Gallus will ensure that Theorem’s customers receive top-notch service and have access to everything they need to advance their trials and prepare for submission success with superior clinical and commercial supply.”