Societal CDMO, Inc., a CDMO dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, has been selected by Spinnaker Biosciences, Inc. to support the company’s clinical development of a novel therapeutic candidate. The activities to be conducted under the agreement include analytical method transfer and qualification, aseptic process development, manufacture of a prototype batch of the therapeutic, cGMP filling of the resultant sterile powder into vials, and stability testing of the therapeutic candidate to be used in a Phase 1/2 study.
 
“Our new agreement with Spinnaker is an exciting opportunity for the Societal CDMO team to showcase its range of expertise across a number of offerings designed to support innovative drug developers as they work to advance novel therapeutic candidates into the clinic. We are well suited to carry out this work which involves several complexities, including aseptic filling of the final product,” said David Enloe, chief executive officer of Societal CDMO. “We are excited to add Spinnaker to our growing list of customers and pleased that the company has entrusted us to carry out these important aseptic process development and manufacturing activities on its behalf.”