May 31, 2017

Case Study: Bioprocess Security of Supply – Whatman™ Chromatography Resins from GE

Human medicine manufacturers need suppliers who will consistently deliver high-quality consumables over decades and communicate transparently when changes are required. GE Healthcare’s approach with Whatman cellulose-based chromatography resins illustrates its commitment to security of supply for biomanufacturers. To address a critical raw material challenge, existing resin stock was reserved for these customers, and a suitable  replacement was identified. Further investment was made to secure resin supply long term by transferring production to a modern facility. In both cases the resins were rigorously validated, and customers received frequent, detailed updates in addition to required change control notifications. Through a combination of cross-functional collaboration, a risk-based change management, and a controlled order intake process including tight collaboration with customers, shortages of human medicines and health products were avoided.

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