Vertically Integrated Continuous Flow mRNA Manufacturing Solution
The Principal Advantages of NTxscribe® Include:
- Unique application of hollow fiber bioreactor for efficient IVT reaction
- Complete set of NTx enzymes for mRNA production
- Single-use, closed system configuration to ensure product sterility
- Decreased shear and handling, minimizing product degradation and contamination
- Streamlines manufacturing operations by reducing batch unit operations
- Enables linear scaling from mg to gram scale
- Benchtop modular design can accommodate different drug substance formats in small scalable footprint
- Allows for integration of in-line process analytics
Producing Conventional and Self Amplifying mRNA
Messenger RNA (mRNA) is a single-stranded RNA molecule that carries the genetic sequence of a gene to a ribosome, the protein synthesis machinery of a cell. The ribosome simultaneously reads the mRNA and synthesizes the corresponding protein encoded by the sequence. All cells need to routinely make mRNA and proteins to regulate protein levels within the cells. Infectious diseases are often also recognized through the immune system by detecting foreign mRNA molecules. Exploiting mRNA as a fast response vaccine candidate was pivotal in the COVID-19 pandemic and will continue to be a powerful solution to combat many diseases of the modern age. NTxscribe® excels across a broad range of mRNA transcript sizes, with a distinguishing ability to produce high integrity saRNA.
Our Process
To support the growing demand for mRNA based vaccines and therapeutics, NTx has developed a first of its kind, proprietary continuous-flow, in-vitro, transcription system utilizing hollow fiber bioreactors. This biosynthetic process provides a low cost and rapidly deployable vertically integrated manufacturing system. This system allows for manufacturing scale from milligram R&D quantities to large scale commercial needs all in a small, economical footprint, with the supply of critical enzymatic components secured by NTx.
All enzymes used in the NTxscribe® platform are engineered with an affinity tag, enabling continuous capture and wash through of all processing steps. In our standard workflow, 5’-capping of the mRNA is accomplished in continuous flow (directly coupled mRNA synthesis).
This unique approach minimizes handling of the material in between production steps, prevents damaging the molecules and ensures integrity, incorporates a purification process that improves yields, and can be scaled up linearly using the same process from discovery through product commercialization, saving valuable time.