Marken, the clinical trial logistics operation with UPS Healthcare, has expanded its global network to support increased demand for its clinical drug supply chain services, particularly for cell and gene clinical trials. Plans for the remainder of 2021 and 2022 will support accelerated demand for mRNA therapies, cell and gene therapies, early access and managed access programs. Expansion plans include new locations, expanded cold chain services and packaging solutions.
“We are accelerating the expansion of our clinical supply chain network across all regions to provide increased flexibility and global access for our partners, including access in emerging markets like South Korea and Sub-Saharan Africa,” commented Ariette van Strien, President of Marken. “These investments are especially critical for cell and gene therapy developers, where we see increased innovation enabled by mRNA, CAR-T, and viral vectors. With the FDA expecting to approve 10 to 20 cell and gene therapy products per year by 2025, our industry-leading network is designed to simplify the transition from clinical trials to commercialisation.”
Marken’s ongoing and planned investments include the addition of more than 100,000ft2 of GMP-compliant depot operations in Louisville, Kentucky, Great Valley, Pennsylvania, and Seoul, South Korea, a new GMP depot facility in Kiev, Ukraine, a new GMP/GDP depot facility in Osaka, Japan and new locations in Nairobi, Kenya and Accra, Ghana. It also includes expansion of its kit assembly facility in Shanghai, China, new liquid nitrogen (LN2) filling stations within each of its global cell and gene centres of excellence, iInfrastructure expansion at its facilities in Belgium, France, South Africa, India, Taiwan, China, and Singapore, and finally packaging and technology enhancements for real-time location tracking and temperature monitoring of cell and gene therapy shipments.
In addition to GMP storage, Marken will be able to track highly sensitive cell and gene therapy, compassionate use, and early access program shipments from its Ukraine facility. This new control center, combined with the existing control centre in Durham, North Carolina, USA, will enhance 24/7/365 global monitoring of all complex shipments, including cell and gene shipments.
Marken’s clinical supply chain network reinforces UPS Healthcare’s continued investment in accelerating cold chain capabilities across the world. In 2021, UPS Healthcare has invested in roughly 390,000ft2 of cold chain GMP storage coolers and freezers installed at UPS facilities to support the storage of biologics ranging from 2°C to as low as -80°C. “UPS Healthcare maintains high standards for excellence in cold chain delivery and logistics, and these current and future investments in innovative solutions will ensure we keep pushing the bar higher,” added Wes Wheeler, President of UPS Healthcare.