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Morphosys

Robust Validation Planning and Transport Simulation Testing Support Accelerated Approval of an Innovative Monoclonal Antibody Cancer Therapy

Challenge

MorphoSys turned to Modality Solutions for the design and execution of transport simulation testing for consistent, repeatable transport validation for their first product – MONJUVI™, a humanized monoclonal antibody for B-cell malignancies.

Objectives

  1. Assess cold chain risks
  2. Mitigate environmental extremes
  3. Define and conduct transport simulation testing and process validation
  4. Identify suitable thermal shipping systems
  5. Write technical sections of the BLA filing
  6. Provide regulatory filing guidance

Results

See how Modality Solutions’ involvement helped MorphoSys achieve FDA approval of MONJUVI™ – the first FDA-approved treatment of this type, filling an urgent, unmet medical need.

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