The company doesn’t have self-manufacturing capabilities for cGMP process liquids, as classified space has been prioritized to support core cGMP product manufacturing for clients. The company planned on outsourcing process liquid manufacturing to third party process liquid CMO partners so they could focus on their core capabilities.
Unfortunately, the company has experienced significant challenges finding CMO partners willing and able to address their needs, which includes small to large cGMP batch sizes, short lead times, as well as services related to stability studies for new solutions. The CMOs the company engaged with all had long lead times and were not willing to provide a service level that addressed the variable demand profile of the CDMO.
The company needed to find a true partner CMO for liquid manufacturing that would address all their needs and position them for success with their clients.
GeminiBio offered the company a compelling value proposition based on GeminiBio’s diversity of cGMP process liquid manufacturing capabilities, including, including 500-liter, 1,000-liter, 5,000-liter, and 10,000-liter single use and stainless-steel mixing vessels. Further, GeminiBio’s TrueCustomSM and ExpressCustomSM service models provided the foundation for the company to achieve the speed and flexibility required to optimize management of their client’s campaigns. Further, GeminiBio was supportive of providing stability study services.
GeminiBio collaborated with the company to complete an extensive audit process and define the end-to-end business processes, including defined service level agreements (SLAs) for both parties, as well as customized custom product documents approved by both parties, to streamline the feasibility and proposal development process for all custom process liquid products.
Specifically, by further refining GeminiBio’s ExpressCustom process, GeminiBio and the company were able to optimize the company’s ability to rapidly respond to the needs of individual clients.
Lastly, GeminiBio and the company developed a master services and supply agreement to cover the manufacturing service level agreements (SLAs), as well as stability study services.