Theorem Clinical Research, a global provider of comprehensive clinical research and development services, has entered an exclusive partnership with Gallus BioPharmaceuticals, a contract manufacturing company based in St. Louis, Mo., to help both companies accelerate their research, development and manufacturing of biopharmaceuticals.
Gallus will provide process development and clinical and commercial supply for mammalian cell-based biopharmaceutical products to Theorem’s customers. In return, Theorem will offer contract research services to Gallus’ customers to increase both companies’ global reach and accelerate their customers’ products through the clinic to market.
The pair’s collaboration aims to support the needs of their customers by outsourcing research, developing ultimate commercial production of products more cost effectively and accelerating the path to market.
“Our intent is to make the process as seamless as possible,” said Mark Bamforth, president and CEO of Gallus.
John Potthoff, CEO of Theorem, said that many of the company’s customers, especially those in Asia, need manufacturing assistance in the U.S. market. According to Potthoff, Theorem’s partnership with Gallus will ensure that Theorem’s customers receive quality service and gain access to everything they need to advance their trials and prepare for submission success with superior clinical and commercial supply.
“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,” Bamforth said.
Theorem provides core CRO services for phases I to IV, but with niche business units in the areas of clinical analytics, medical device and pharmaceutics. Gallus’ facilities are designed to support the development of early-phase processes through scale-up and full clinical and commercial production.