Case Study: How Transport Simulation Helped This ADC Therapy Achieve Fast-Track Approval

Background

The Immunomedics team wanted to assure the quality and integrity of their Antibody-Drug Conjugate (ADC) therapy is maintained throughout the entire supply chain. They amended their validation master plan for commercial approval by the US and EU regulatory bodies.

They asked for Modality Solutions’ assistance in preparing responses to information requests (IR) received on their filing at various points during the project, many of which focused on their shipping validation strategy.

Objectives

  • Conduct risk assessment on the process steps of the Antibody-Drug Conjugate therapy to identify mitigation strategies and inform the validation master planning strategy.
  • Create a validation master plan (VMP) that includes packaging qualification and transport validation.
  • Qualify thermal packaging for refrigerated (2-8°C) and deep-frozen (≤-80°C) shipments.
  • Execute transport simulation studies to confirm ADC therapy quality through the entire supply chain
  • Prepare transport validation summary report for filing

Results

  • Modality Solutions assisted Immunomedics in satisfactorily responding to information requests from the FDA and addressing the complete response letter in the first two weeks of the engagement.
  • Immunomedics successfully resubmitted their BLA for sacituzumab govitecan and on December 26th, 2019 it got accepted for accelerated review.