Societal CDMO, Inc., a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, has unveiled the company’s new “20/80 Second Source Technical Transfer” service model. This new offering is designed to provide pharmaceutical companies with a time- and cost-efficient preparedness strategy for mitigating supply chain risks and vulnerabilities. Societal introduced the model in conjunction with the CPhI North America 2022 Meeting, held May 17-19, 2022, in Philadelphia, PA.
 
Societal created this new service model in response to the growing risks and vulnerabilities associated with the global supply chain that have significantly elevated the importance of second source suppliers within the pharmaceutical industry. This volatility has created an environment in which risk mitigation, reshoring of manufacturing to the U.S., and supply chain continuity have become much more critical considerations for supply chain management within the pharmaceutical sector.
 
Under the framework of Societal’s “20/80 Second Source Technical Transfer” model, pharmaceutical companies are able to collaborate with Societal to execute all sourcing and planning phase activities of a standard technical transfer process prior to the time that product supply is needed. By undertaking these activities in advance, customers can complete approximately half of the technical transfer process and position themselves to initiate the transfer of material and commence the batch manufacturing (execution phase) whenever new and/or additional finished drug product supply is required.
 
By executing the materials sourcing, planning and other production preparation phases of the technical transfer, a Societal customer can be “supply ready” approximately a full year sooner than if it commenced these activities at the onset of a supply disruption. According to the company, investing in the initial sourcing and planning phase activities accounts for 20 percent, on average, of the total technical transfer costs for a commercial product, whereas the execution/manufacturing phase makes up the remaining 80 percent of costs.
 
“We believe that this new service offering addresses a critical and growing need in the pharmaceutical manufacturing space, allowing Societal customers to achieve cost and time savings while establishing a back-up plan that we view as akin to insurance for safeguarding the continuity of their supply of important drugs to the patients we all ultimately serve. Essentially, customers will be able to complete approximately 50 percent of a tech transfer project timeline while committing roughly  20 percent of the total costs upfront, offering the peace of mind that comes with being prepared to quickly respond to any issues that arise within their supply chain,” said David Enloe, chief executive officer of Societal CDMO. “In addition to the valuable cost and timing savings provided by this program, it also helps our U.S. customers address several additional industry hot-button issues, such as the need for trusted second sources and reshoring of manufacturing activities. We are eager to deliver this unique service offering to our current and future customers.”