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Case Study

Innovative Biotech Company Provides First FDA Approved Immunotherapy Cancer Therapy

First FDA Approved Immunotherapy Cancer Therapy.


Challenge:

Production of personalized immunotherapy requires collection of patient apheresis from centers throughout the US, delivery of apheresis to the manufacturer of the immunotherapy medication and then delivery to a medical facility for infusion. Process requires extremely tight deadlines and precise planning. Often, the location of Apheresis Centers and Infusion Sites causes commercial airline flight limitations. Chain of custody critical to ensure personalized medication is delivered to the correct patient on time, temperature integrity intact. Biotech company wants to expand the life-saving therapy to more patients, however, they were restricted due to location of manufacturing centers, patient limitations and tight time frame for scheduling infusions.



Solution:


  • Consultation and pre-planning for safest routings and contingency plans to reduce risk of delays and temperature excursions
  • Next Flight Out, Next Direct Drive Out and exclusive Charters arranged within minutes for critical situations nationwide
  • Continuous monitoring to ensure tight deadlines and approved packaging processes and procedures are met: collecting a patient apheresis and delivering to a vaccine manufacturing facility within 17 hours, and returning personalized medication to infusion site within 17 hours
  • Strict temperature control standards applied throughout transit
  • Continuous contingency planning to proactively prepare for adverse weather conditions and other potential transportation interruptions, circumventing potential delays
  • Strict Chain of custody protocols utilized throughout entire supply chain, to include use of unique ID number, confirmation of chain of ID number at every step, up until final delivery