MorphoSys contacted Modality Solutions to establish a commercial supply chain (packaging and logistics) to support the marketing application for its first product launch, MONJUVI™. Modality Solutions provided FDA regulatory experience, a robust transport validation approach and access to transport simulation expertise ensuring a positive response for BLA, PAI, and future biennial inspections.
- Conduct risk assessment with
mitigation planning to cover high risks
- Qualify thermal shipping systems
- Execute transport simulation studies
- Present transport validation master plan results to regulators
- First FDA approval of the first treatment in second-line treatment for adult patients with relapsed DLBCL
- MorphoSys met all milestones for the FDA fast-track, breakthrough therapy, and priority review
- MorphoSys is commercializing MONJUVI™ in the U.S. Incyte will commercialize MONJUVI™ outside the U.S.