Company had been making required process liquids – lab scale – internally, but had required water for injection (WFI) from external suppliers, which were routinely backordered and consistently failed to meet delivery promises. Further, as process liquid volumes began to increase during process development, company required an outsourcing partner to simplify the workflow.
The company also required a process liquid manufacturing partner who could scale both from non-cGMP to cGMP manufacturing, as well as from small batch sizes to batches between 1,000-liters to 3,000-liters, as the company progressed into their clinical development stage.
Company was continually frustrated with finding a liquid manufacturing partner that was willing to address their needs.
GeminiBio worked with the company to immediately address their needs for water for injection (WFI) with GeminiBio’s readily available GemPureTM Select Water for Injection (WFI) Quality Water.
GeminiBio collaborated with the customer to document detailed product specifications and requirements, including all component specifications and release criteria requirements, for > 10 development buffers in batch sizes from 50-liters to 800-liters. GeminiBio completed feasibility and the custom product proposal within 7 days for the customer’s development buffers and manufactured all solutions < 10 weeks from receipt of the purchase order.
Following the manufacturing of repeated orders for the company’s development buffers, GeminiBio collaborated with the company to develop buffers in support of the company’s transition to cGMP product manufacturing.
Note that all of GeminiBio’s process liquids provided to the company were manufactured under cGMP in GeminiBio’s ISO 13485 and 21 CFR 820 compliant facility.