Regeneron
Plunger Movement Studies Helped Regeneron Confirm Drug Sterility and Meet Tight BLA Filing Timelines
Challenge
Regeneron Pharmaceuticals turned to Modality Solutions to ensure its biologics in pre-filled syringes (PFSs) remain sterile under low-pressure conditions during transit.
Objectives
- Evaluate low pressure effects on plunger movement
- Determine adequacy of plunger placements
- Assess drug product sterility throughout low-pressure exposure
Results
See how Modality Solutions designed and conducted seven plunger movement studies covering four products, in less than one week, to confirm drug sterility throughout the supply chain and meet FDA requirements.
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