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Under two new agreements, Societal CDMO will offer analytical, technical transfer, formulation, manufacturing, and packaging services for novel therapeutics.
Societal CDMO, a US-based contract development and manufacturing organization (CDMO), announced on Oct. 20, 2022 that it has entered into two new contract development and manufacturing (CDMO) service agreements. Under the new agreements, the company will offer a range of analytical method, technical transfer, formulation, manufacturing, and packaging services in support of ongoing development programs for novel therapeutic candidates.
With the first contract, the services provided will go toward supporting the ongoing clinical development of a modified release, bead-filled capsule formulation of an oral biologic that is already approved in Canada and indicated for pancreatic insufficiency. The range of services under this contract will include analytical method development and validation, technical transfer combined with formulation optimization, clinical trial batch manufacturing, and primary packaging for the drug. Societal CDMO’s activities will also support a planned Phase III clinical trial as part of an ongoing clinical development program for the drug in the United States.
Under the second contract, Societal CDMO will conduct a range of activities to support the development of a novel interleukin-2 (IL-2) analog for the treatment of cancer. The company will provide services such as formulation development, analytical method transfer and verification, and good manufacturing practice (GMP) batch manufacturing as well as fill/finish. The program for this drug is currently in preclinical development.
“[O]ur 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, CEO of Societal CDMO, in a company press release.
Source: Societal CDMO