The company’s pipeline includes products spanning preclinical, Phase 1, and Phase 2 clinical trials. However, the company lacks the internal cGMP liquid manufacturing capabilities to support their projects once they reach pilot scale and beyond.
Given the pace of their projects, the company required a nimble partner to rapidly manufacture and adjust buffers for process optimization. Further, the partner needed to be able to support both development and cGMP stages of the company’s pilot manufacturing.
GeminiBio worked closely with the company to define all specifications and requirements for 10 different buffer solutions, completing feasibility, custom product proposals, and providing a quote within 10 days.
GeminiBio custom manufactured buffers ranging in a batch size of 100-liters to multiple batches of 1,000-liters. GeminiBio manufactured and delivered the custom buffers within 8 weeks of the purchase order.
As a result of GeminiBio’s TrueCustomSM and ExpressCustomSM service models, the company was able to support their pilot scale projects and is poised to further leverage GeminiBio’s capabilities as their projects advance in the clinical process and begin to require cGMP batches greater than 1,000-liters.