Societal CDMO, a CDMO dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, announced new project expansion agreements across four different current customers.

The recently signed work expansion agreements include:
 
Increasing the batch size for an ongoing design of experiments (DoE) study of an approved chemotherapeutic agent, with incorporation of additional blending and compaction specifications for the tablets.
 
Execution of surrogate batch manufacturing and testing for an approved chemotherapeutic agent, as well as manufacturing of a development batch for a coating DOE study of the same compound.
 
Analytical method development and validation, along with clinical trial material batch manufacturing of a fixed-dose combination of an approved chemotherapeutic agent and a compound that enhances chemotherapeutic agent’s bioavailability and systemic exposure.
 
Broadening of clinical trial services related to a U.S.-based Phase 2 study of a novel melatonergic antidepressant already approved for use in Europe and Australia. The expanded activities will focus on over-labeling on both placebo and active bottles under cGMP conditions to support expiry extension.
 
Dissolution testing on a prototype development batch of a novel multiparticulate-filled formulation of an investigational compound being developed for the treatment of a range of neurodegenerative diseases. This expanded scope of work also includes the preparation of up to five additional prototype batches of immediate release (IR) formations of the drug candidate, including a range of in-process tests on each IR batch.
 
Dissolution testing on engineering batches of an approved anticancer therapeutic, as well as assay testing on engineering and process performance qualification batches.
 
“This recent flurry of work expansion agreements with several of our existing customers is a strong indication of the momentum that our business development, project management and operations teams continue to generate despite the challenging financial dynamics that are broadly impacting the drug development industry,” said David Enloe, chief executive officer of Societal CDMO. “We take great pride in these work expansions as they not only contribute to growing our revenue but also demonstrate the trust that we are able to build with customers once they are engaged with the Societal organization. Equally impressive is the wide range of CDMO services covered by these agreements across myriad therapeutic areas, highlighting the breadth of capabilities and expertise we possess throughout our bi-coastal operations.”