Societal CDMO, a contract development and manufacturing organisation dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, has unveiled its new '20/80 Second Source Technical Transfer' service model.
This new CDMO offering is designed to provide pharmaceutical companies with a time- and cost-efficient preparedness strategy for mitigating supply chain risks and vulnerabilities.
Companies can execute all sourcing and planning of a standard technical transfer process prior to the time that product supply is needed
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. Over the past decade, supply chains in the global life sciences industry have been increasingly interrupted and/or impacted by a broad range of natural disasters, geopolitical threats, and regulatory/compliance failures, as well as the global COVID-19 pandemic.
This volatility has created an environment in which risk mitigation, reshoring of manufacturing to the US, and supply chain continuity have become much more critical considerations for supply chain management within the pharmaceutical sector.
The model
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, Societal 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.
Customers will be able to complete approximately 50% of a tech transfer project timeline while committing roughly 20% of the total costs upfront
Importantly, investing in the initial sourcing and planning phase activities accounts for 20%, on average, of the total technical transfer costs for a commercial product, whereas the execution/manufacturing phase makes up the remaining 80% 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" said David Enloe, CEO of Societal CDMO. "Essentially, customers will be able to complete approximately 50% of a tech transfer project timeline while committing roughly 20% 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."
Enloe further explained that in addition to the valuable cost and timing savings provided by this programme, it also helps the company'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," he said.
