Societal CDMO, Inc., a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges primarily in small molecule development, has signed service agreements with two new customers. The contracts are focused on a range of analytical method, technical transfer, formulation, manufacturing and packaging services to support ongoing development programs for novel therapeutic candidates.
 

Under the first contract, Societal CDMO will provide services to support the ongoing clinical development of a modified release, bead-filled capsule formulation of an oral biologic indicated for pancreatic insufficiency. Services will include analytical method development and validation, technical transfer combined with formulation optimization, clinical trial batch manufacturing, and primary packaging for the drug, which is already approved in Canada. Societal CDMO’s activities will support a planned Phase 3 trial as part of the customer’s ongoing clinical development program for the drug in the U.S.
 

As part of the second agreement, Societal CDMO will conduct a range of activities supporting a new customer’s development of a novel interleukin-2 (IL-2) analog for the treatment of cancer. The services provided will include formulation development, analytical method transfer and verification, and GMP batch manufacturing and fill/finish related to the program, which is currently in preclinical development.
 

“These new contract wins help continue to grow our business while further diversifying our customer base. In particular, our support of the late clinical-stage oral biologic program has the potential to contribute to an increase in our commercial revenues, and is also evidence of the strong reception that our Clinical Trial Services offerings are receiving from drug developers,” said David Enloe, chief executive officer of Societal CDMO. “We are grateful for the trust that these new customers have placed in our team to support the development of their innovative drug candidates. We look forward to delivering an exceptional experience that exceeds their expectations.”