Company doesn’t have cGMP process liquid manufacturing on-site and has purchased water for injection (WFI) and custom process liquids from contract manufacturers. Inconsistent service and long-lead times have resulted in delayed execution of client campaigns. Client satisfaction has suffered.
Company requires a contract manufacturer for cGMP process liquids that can commit to flex to the rapid and iterative changes in process development, as well as inherent schedule changes often required by the company’s end-customer.
GeminiBio offered the company a compelling value proposition based on GeminiBio’s diversity of cGMP process liquid manufacturing capabilities, 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.
GeminiBio collaborated with the customer 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 ExpressCustomSM 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 supply agreement to include consistent manufacturing lead times no greater than 10 weeks.