CHALLENGE

A potentially life-saving allogeneic cell therapy manufactured in Europe had to be administered to patients within 48 hours of constitution. With several patients in the U.S. using the therapy, the drug manufacturer was faced with a crisis when 90% of international passenger flights were grounded due to COVID-19. In addition to being time-sensitive, the therapy needed to be transported at 2º to 8ºC – from the point of collection through to delivery at various hospital sites.

SOLUTION

Working closely with the drug sponsor in Europe, QuickSTAT delivered therapy doses to various US-based hospital sites within the 48-hour timeframe, including customs clearance by:

• Providing and conditioning a 2º to 8ºC Phase Change Material (PCM) shipper designed specifically for refrigerated products
• Using a dedicated air charter flight, which allowed therapies to be delivered to numerous hospital sites throughout the US in time for scheduled patient dosing
• Ensuring all regulatory paperwork was in order so that therapies would move through the customs clearance process as quickly as possible
• Monitoring temperatures from pick-up at the manufacturer’s site through to delivery at each hospital
• Ongoing communication, informing all parties involved of key milestones throughout transit – from the point of collection until it arrived at each hospital for patient treatment

OUTCOMES 

• Patients received the life-saving allogeneic cell therapy within the timeframe and temperature range required