Gallus BioPharmaceuticals, LLC has announced its acquisition of Laureate Biopharmaceutical Services, Inc. (Laureate), a full service biologics CMO located in Princeton, New Jersey.
This acquisition doubles Gallus’ process development (PD) and clinical drug substance manufacturing capacity, adds full protein characterization, testing and clinical fill-finish capability and offers a seamless development pathway for clients - from early stage PD and clinical manufacturing to commercial manufacturing.
United by a common mission to deliver outstanding clinical and commercial CMO services, the merged companies combine two organizations with proven track records and offer clients two Centers of Excellence for manufacturing therapeutic proteins using mammalian cell-culture: The Princeton site is a Center of Excellence for PD solutions and manufacture of clinical-stage products, including fill-finish; the St. Louis site is a Center of Excellence for PD, clinical and commercial manufacture of biopharmaceutical products.
Both sites are FDA approved, while the St. Louis site is also licensed by every major regulatory authority globally.
Gallus, a pure-play CMO, now has multiple clinical and commercial suites at the two sites, with 50L to 2,000L GMP single-use platforms from Xcellerex™ and HyClone™ in addition to 50L to 2,000L fixed and flexible stainless steel bioreactors and associated downstream purification for drug substance.
Additionally, clinical fill-finish capabilities are part of the Princeton site. All of these services will be delivered by the combined team of 350 experienced and dedicated staff.
Michael A. Griffith, Laureate CEO, who will support the transition for several months, stated that, "The merger of Laureate into Gallus benefits our clients and our employees by creating a more secure and diverse platform including important additional technologies and capabilities. Our client portfolio includes late-stage clinical programs advancing towards launch that will immediately benefit from the commercial readiness of the Gallus St. Louis site. Importantly, we believe that the service mindsets of Gallus and Laureate are well matched."
Mark R. Bamforth, Gallus President and CEO, stated “This acquisition is another important step towards realizing Gallus’ vision to be the most trusted provider of world class biologics manufacturing and development services for the pharmaceutical and biotechnology industry. By combining Laureate and Gallus, we double the development and clinical capacity of Gallus with a uniquely flexible combination of stainless steel and single use technologies and capacities to suit every client’s process needs. Critically, we have an established, reliable commercial pathway for late stage molecules and expect to continue to grow our organization and make further capital investments to serve client needs.”