mRNA Beyond COVID: The 2026 Oncology Supply Chain Playbook
But inside the biopharma boardrooms, the conversation has shifted. The future of mRNA isn’t about COVID anymore — it’s about oncology. Dozens of clinical trials are testing therapeutic vaccines and personalized cancer treatments. The science is moving faster than ever.
Here’s the catch: the bottleneck is no longer discovery, it’s manufacturing and supply. Experts in the field are clear: unless the industry can secure GMP-grade raw materials, optimize large-scale IVT, and guarantee regulatory documentation, oncology mRNA won’t achieve the same breakthrough speed we saw in 2020.
This playbook summarizes what industry leaders are learning about mRNA in oncology — and how DKSH is helping them prepare.
The Manufacturing Bottlenecks
- IVT bottlenecks: GMP-grade T7 polymerase, capping enzymes, and NTPs are in high demand.
- Scaling challenges: CHO and HEK suspension systems need optimized media to sustain yields.
- Documentation delays: INDs are slowed by gaps in DMF-backed raw materials.
- Cold-chain fragility: Oncology trials require cross-border, temperature-stable logistics.
The Solutions
- GMP Enzymes toolkit: T7 polymerase, RNase inhibitors, pyrophosphatase, vaccinia capping enzymes — backed by 15 FDA-filed DMFs.
- Quality Control for mRNA Substance: qualified ELISA kits, from mRNA Capping Detection to dsRNA Detection or E. Coli detection.
- Regulatory foresight: Compliance with ISO standards, FDA-filled DMF and Halal certification.