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In this partnership, 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. This partnership allows both companies to increase their global reach and get their customers’ products through the clinic to market much faster.
The collaboration between Gallus and Theorem aims to address the time and cost issues of the current model of sponsor company and service provider relationships, a problem that’s been a recent topic of conversation in the industry. They hope to do this by supporting the needs of their customers to outsource the research, development and ultimate commercial production of products more cost effectively and to accelerate the path to market.
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.
CEO John Potthoff said that many of their 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 service and have access to everything they need to advance their trials and prepare for submission success with superior clinical and commercial supply.
Gallus is a CMO operating a commercially licensed manufacturing site in St. Louis. With more than 25 years of experience in process development and a decade of commercial manufacturing, the company’s facilities are designed to support the development of early-phase processes through scale-up and full clinical and commercial production.
Gallus President and CEO Mark Bamforth said that Gallus’ mission is to meet the biopharmaceutical supply needs of customers through a manufacturing operation, leveraging the organization’s experience in development and manufacturing with an entrepreneurial, innovative, customer focus.