It has expanded its cold chain services and packaging solutions, whle new storage locations in Kenya and Ghana are in the pipeline. The idea is to provide increased flexibility and global access for customers, including in emerging markets like South Korea and Sub-Saharan Africa.
The UPS subsidiary sees the investments as especially critical for cell and gene therapy (CGT) developers, where there is increased innovation enabled by mRNA, CAR-T, and viral vectors. and huge growth forecast for that segment. The US Food and Drug Administration (FDA) is expected to approve 10 to 20 CGT products per year by 2025.
Ariette van Strien, president of Marken, told BioPharma-Reporter: “Expanding our GMP network, including cold chain, is critical for cell and gene therapy developers as it allows them to reach patients in previously unreached populations. We’re excited about our planned expansion into Ghana and Kenya as it can help with temporary and permanent storage of mRNA vaccines or even cell and gene therapies to these regions.”
Marken’s ongoing and planned investments include:
- The addition of over 100,000 square feet of GMP-compliant depot operations in Louisville, KY, Great Valley, PA, and Seoul, South Korea.
- A new GMP depot facility in Kiev, Ukraine.
- A new GDP depot facility in Osaka, Japan.
- New locations in Nairobi, Kenya and Accra, Ghana.
- Expansion of its kit assembly facility in Shanghai, China.
- New liquid nitrogen (LN2) filling stations within each of its global cell and gene centers of excellence.
- Infrastructure expansion at its facilities in Belgium, France, South Africa, India, Taiwan, China, and Singapore.
- Packaging and technology enhancements for real-time location tracking and temperature monitoring of cell and gene therapy shipments.
In addition to GMP storage, the company will be able to track cell and gene therapy, compassionate use, and early access program shipments from its Ukraine facility.
“This new control center, combined with the existing control center in Durham, NC, US, will enhance 24/7/365 global monitoring of all complex shipments, including cell and gene shipments.”