Theorem Clinical Research (Theorem) has entered an exclusive partnership with Gallus BioPharmaceuticals (Gallus).
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 to increase both companies’ global reach and accelerate their customers’ products through the clinic to market.
According to an article by Outsourcing-Pharma writer Natalie Morrison, the current working relationship between sponsor companies and service providers is too lengthy and costly because it is based on ideas that are up to a century old.
Morrison adds that combining contract research organization (CRO) and contract development and manufacturing organization (CMO) activities, the development paradigm becomes much smoother and more efficient.
Gallus and Theorem agree with Morrison’s findings and their collaboration is aimed at addressing this issue 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.
“Our intent is to make the process as seamless as possible,” said Gallus President and CEO Mark Bamforth.
Theorem is one of the industry’s leading full-service, global CROs providing core clinical research and development services.
The company provides core CRO services for Phases I to IV, but with niche business units in the areas of clinical analytics, medical device and pharmaceutics.
Theorem Chief Executive Officer John Potthoff said that many of Theorem’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 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.
Gallus is a world-class 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.
Bamforth said that Gallus’ mission is to meet the biopharmaceutical supply needs of customers through a premier manufacturing operation, leveraging the organization’s deep experience in development and manufacturing with an entrepreneurial, innovative, customer focus.
“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,” he said.