The company’s on-site buffer manufacturing capabilities were limited in scale and non-cGMP and they required a range of cGMP manufactured process liquids to support their upstream and downstream therapeutic cell manufacturing process steps as they progressed in their development process.
Ultimately the company decided that they needed an external manufacturer who could make cGMP process liquids – cost effectively – in the small aliquots required for their current workflow process steps. Further, the company wanted specific reagents in single use, closed systems which can easily be sterile welded to improve the overall aseptic process across their workflow.
GeminiBio worked with the company to determine the specific specifications and requirements, including component specifications and release criteria, for each of the process liquid solutions.
GeminiBio was able to finalize feasibility and provide custom product approval packets within 10 days for company review and approval.
Following company approval and receipt of the purchase order, GeminiBio custom manufactured cGMP products ranging in batch sizes from 30-liters to 300-liters and in custom package sizes, including 30 mL of product in 100 mL bioprocess container and 1-liter of product in 1-liter bag with weldable tubing.