Request a consult
Resources / Immunomedics

Immunomedics

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

Challenge

As Immunomedics prepared for the launch of its new antibody-drug conjugate (ADC) after Fast-Track approval from the FDA, the company turned to Modality Solutions for assurance it could maintain product integrity throughout the cold chain

Objectives

  1. Cold chain gap assessment and drug product risk assessment
  2. Action plans to address assessments
  3. Updated validation master plan
  4. Thermal packaging qualification for refrigerated and frozen shipments
  5. Countermeasures for potential licensure application issues
  6. Information Request responses and a Complete Response Letter

Results

See how Modality Solutions helped Immunomedics respond satisfactorily to the FDA’s Information Requests and address the Complete Response Letter in just two weeks.

Download the full case study



View all case studies