Case Study: How Robust Validation Planning and Transport Simulation Helped With FDA & EMA Accelerated Approval of MONJUVI™
MORPHOSYS, image of MORPHOSYS logo

Background

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.

Objectives

  • 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

Results

  • 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.

Did you know transport simulation testing is critical for fast-track filing?

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