The Shift Towards an Integrated Supply Model
The biopharmaceutical sector is entering a new phase shaped by the clinical and commercial momentum
of nucleic acid therapeutics (NATs), which include mRNA-based products and oligonucleotide therapeutics
such as siRNA and ASOs, as well as sgRNA used in gene editing programmes. Together, these technologies are
expanding treatment options by enabling precise genetic targeting and adaptable therapeutic design.
Since the first nucleic acid-based therapeutic approval in 1998, the field has expanded to more than 20 approved
products, with hundreds of ongoing clinical trials.1 As more programmes move toward larger studies and commercial supply, manufacturing expectations are tightening around consistency and scalable execution. The field’s expansion is exposing vulnerabilities that challenge scalability, quality consistency and speed to clinic.
In response, some contract development and manufacturing organisations (CDMOs) are adopting a vertically integrated supply model that unites raw material synthesis with GMP production of drug substance and drug product within the same company. By aligning key production stages, this approach can support reliability and scalability while strengthening operational control.
This article examines how vertically integrated models are being applied to mRNA and oligonucleotide
manufacturing and how this approach is influencing the standards of efficiency and quality in NAT development and manufacturing.
