Societal CDMO, Inc. announced a new customer project utilizing its automated fill/finish line and lyophilization unit at the company’s San Diego facility.  The recently initiated project is focused on formulation development and sterile GMP manufacturing of a lyophilized novel cancer therapeutic for intravenous infusion. Societal has been contracted by an emerging Japan-based biopharmaceutical company to support the company’s ongoing clinical development of the compound as a potential treatment for solid tumors.
 
Societal’s aseptic fill/finish suite features a sterile, automated vial filling system with the capability to fill up to 2,000 presterilized vials per hour at a range of volumes. The company’s lyophilization offering incorporates a novel approach to uniformity and instantaneously induces nucleation via pressurization and depressurization. This equipment provides the capacity for lyophilization of approximately 9,000 10 mL vials during each 3-5 day freeze-drying cycle.
 
“Our decision to add fill/finish and lyophilization capabilities to our suite of CDMO services was driven by the opportunity to unlock an additional revenue source for the company and further our goal of providing end-to-end CDMO services for our customers. With ongoing customer activities moving through our fill/finish and lyophilization unit, we are now directly realizing those important benefits that triggered this strategic service expansion,” said David Enloe, chief executive officer of Societal CDMO. “It is important to note that we are undertaking this project on behalf of a Japan-based biopharma, which we believe is yet another example of a growing interest among ex-U.S. drug developers to conduct critical CDMO activities within the U.S. As such, we expect that having a bi-coastal base of operations in the U.S. will continue to serve as a competitive advantage for Societal.”