Societal CDMO Announces Signing of Multiple New CDMO Service Agreements
Societal CDMO, Inc. recently announced it has signed CDMO service agreements with two new customers. These contracts are focused on a range of analytical method, technical transfer, formulation, manufacturing, and packaging services designed to support ongoing development programs for novel therapeutic candidates.
Under terms of the first new 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. This range of 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 clinical trial as part of the customer’s ongoing clinical development program for the drug in the United States.
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 by Societal CDMO 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.”
Societal CDMO is a bi-coastal contract development and manufacturing organization (CDMO) with capabilities spanning pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms with a primary focus in the area of small molecules. With an expertise in solving complex manufacturing problems, Societal CDMO is a leading CDMO providing therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging, and logistics services to the global pharmaceutical market.
In addition to our experience in handling DEA-controlled substances and developing and manufacturing modified-release dosage forms, Societal CDMO has the expertise to deliver on our clients’ pharmaceutical development and manufacturing projects, regardless of complexity level. We do all of this in our best-in-class facilities, which total 145,000 square feet, in Gainesville, GA, and San Diego, CA. For more information, visit societalcdmo.com.
Total Page Views: 702
