Marken successfully orchestrated the distribution of the first commercial CAR-T therapy drug product from the USA to a hospital in Japan, despite facing time and temperature-sensitive challenges.
To ensure the high-profile care and visibility of the shipment throughout transport, Marken's Regulatory and Compliance experts, Customer Relations Management, and CGT Operations teams aligned all key stakeholders to execute the distribution strategy with end-to-end transparency, overcoming complex regulations for CGT therapies mandated by the Japanese government.
The Goal...
The goal was to orchestrate a specialized distribution strategy by expediting the first commercial live shipment of temperature-critical autologous final CAR-T drug product from the USA manufacturing site to the hospital in Japan.
The Challenge...
- Navigate time and temperature-sensitive requirements of transporting a CAR-T drug product in a highly controlled region with strict Japanese healthcare regulations
- Comply with unique and rigorous client and procedure requirements specific to Japan biopharma market
- Manage last minute client request to change customs import broker, just before first live shipment release
- New broker chosen had minimum dry run experience for CGT therapy logistics
The Solution...
Working closely with the client, Marken’s specialized CGT Japan team developed an internal communications program, with training tools and customized operational processes to ensure high-profile care and visibility of the shipment throughout transport.
This included:
- Constructing and implementing a new qualification system for drivers to provide mandatory training and knowledge testing of procedure protocols, while following business culture in Japan
- Performing risk lane assessments to ensure on time delivery
- Performing dry run exercises with the local service provider (LSP), a member of Marken’s CGT team personally accompanied the driver to ensure successful collection and delivery orchestration
Marken’s Regulatory and Compliance experts, Customer Relations Management and CGT Operations teams aligned all key stakeholders to execute distribution strategy with end-to-end transparency.
The team streamlined the customs clearance process with the broker, overcoming complex regulations for CGT therapies mandated by the Japanese government.
The Outcome...
The CAR-T drug product was delivered on time and within temperature specifications to the hospital. Following this success, Marken continues to transport live-saving therapies to other locations in Japan and throughout the Asia-Pacific region.
About Marken
Marken is the clinical precision logistics and advanced therapy subsidiary of UPS Healthcare. The UPS Healthcare network consists of 200+ locations worldwide.
Marken offers a state-of-the-art GMP-compliant depot network and logistic hubs for clinical drug product storage and distribution in 46 locations worldwide, while maintaining the leading position for cell and gene therapy services, direct-to-patient and home healthcare services, biological sample shipments and biological kit production. Marken’s dedicated 2,600+ staff members manage 200,000 drug product and biological sample shipments every month at all temperature ranges in more than 220 countries and territories and have orchestrated 17,500+ home healthcare visits. Additional services such as ancillary material sourcing, storage and distribution, shipment lane verification and qualifications, as well as GDP, regulatory and compliance consultancy add to Marken’s unique position in the pharma and logistics industry.
Delivering What Matters From Clinical to Commercial.
