Case Study: Product Development
Challenge: A large bio-biopharmaceutical company needed to launch a new instrument that required fluidics into the cell biology market. The immediate challenge was the need to deliver a solution quickly as the device had high expectations for launch.
Solution: QBI developed product formulation, packaging, customized the manufacturing fill and finish process, and completed validation in 9 months.
Results: The customer met on-time launch deadline of the new instrument.
Case Study: Process Development
Challenge: Start-up biotechnology company approached us for large-scale manufacturing of a reagent they had only prepared at a small scale in their lab.
Solution: QBI proposed a pilot lot production to work out conditions (mixing time, exposure to light, filling and packaging), QC requirements (type and schedule of QC tests, product performance determined by cell-based assay), storage and shipping conditions (room temperature vs. ice packs), and cost based on material and production conditions.
Results: After review of data generated by the pilot lot, the customer revised production requirements to those proposed by QBI and signed a supply agreement with us for production of commercial lots.