NTx is enabling global access to tomorrow’s vaccines and therapeutics, today.
Utilizing NTx’s continuous flow system for your synthesis and scale up RNA program will inherently overcome many of the challenges and drawbacks experienced in the current manufacturing processes to provide a more flexible, efficient manufacturing process in a smaller and safer facility.
Allows unmatched flexibility, provides the ability to respond to rapidly changing demands in GMP manufacturing:
NTx’s design uses modular technology that presents a high degree of flexibility and scalability to meet changing production needs. And presents the following advantages:
- Ability to rapidly scale up/scale out to meet changing demand of any given product.
- Disposable technology removes plant bottlenecks associated with CIP/SIP. Also simplifies facility design and start-up requirements for equipment validation and automation. Results in lower capital cost and faster facility build-out.
- A fully closed system enables multi-product manufacturing, a benefit for facilities with a dynamic product portfolio.
- The hardware of the system is modular, so additional post IVT processing and purification can be implemented to meet the requirements of any therapeutic.
- Distributed manufacturing.
Shortens traditionally long discovery and development cycles:
NTx’s adaptable platform technology can be rapidly deployed to synthesize and manufacture different drug candidate, realizing the opportunity to bring more compounds through the development process faster which provides a longer patent life-time in the market.
Overcomes presently high discovery, development and manufacturing costs:
Compared to traditional technology for biologics, adoption of NTx’s system requires less complex equipment and facilities, will capitalize on the ease of increasing manufacturing scale with lower capital expenditure.
Eliminates high dependency on a fragile supply chain:
NTx’s unique design does not require complex and fragile supply chain processes. The NTx consumable kits are assembled using standard, single-use components for a more robust supply chain and a fully controlled vertically integrated supply. Furthermore, NTx produces and provides all the enzymes and reagents required for the procedure which alleviates dependency on third party vendors in the supply chain.
Reduces cost and time of product generation:
NTx’s biomanufacturing process is a closed continuous flow process that requires no material or component handling that inherently reduces risk of contamination. The industry-leading process technology realizes reduced formation of product- and process-related impurities, resulting in higher yield and less purification steps.
Lessens environmental impact of pharmaceutical manufacturing:
NTx’s biomanufacturing technology approach generates a high yield of product with significantly better product/waste ratio, and a much smaller footprint than current large scale processes.
Reduces safety incidents in manufacturing environment:
NTx’s manufacturing technology presents a much safer operational environment. By design, it does not present typical work hazards, such as caustic and solvent exposure, steam/high temperatures, high pressure gases, or ergonomic issues due to bulk material handling.
Vertically integrated continuous flow mRNA manufacturing solution.
Producing Conventional and Self Amplifying mRNA
Messenger RNA (mRNA) is a molecule of nucleic acids that helps the genes in a cell’s nucleus communicate with its protein manufacturing complex. All cells need to routinely make protein and mRNA helps to regulate protein level within the cells and infectious diseases are often also recognized through the immune system by detecting foreign mRNA molecules. Exploiting mRNA as a fast response vaccine candidate has been very helpful in the latest pandemic and might be a powerful solution to combat many diseases of the modern age.
Our mRNA Technology
THE PRINCIPAL COMPONENTS OF NTXSCRIBE® INCLUDE:
- Unique bioreactor design
- Complete set of enzymes to produce the mRNA sequence, add the 5’cap and poly(A) tail
- Specially designed glovebox that maintains the sterility of the workspace
To support the growing demand for mRNA based vaccines and therapeutics, NTx has developed a first of it’s kind, proprietary continuous-flow, fully recombinant, in vitro, cell-free, transcription system utilizing hollow fiber bioreactors. This biosynthetic process is designed to provide a low cost and rapidly deployable, vertically integrated manufacturing system. This system allows for manufacturing scaling from R&D quantities to commercial needs in a small, economical footprint, with the supply of critical enzymatic components secured by NTx.
All enzymes used in the NTxscribe® platform, including the m7G-capping (cap0), the cap1-generating enzymes and poly(A) polymerase, are engineered with an affinity tag, enabling continuous capture and wash through of all processing steps. In our standard workflow, 5’-capping and 3’-poly(A) extension of the mRNA are 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 through the product commercialization, saving valuable time.
Fully recombinant in vitro protein manufacturing
First and only fully recombinant cell-free expression system to produce proteins and minimize unwanted cellular metabolism
Extract-based in vitro systems are challenged by:
- Residual metabolic activity lowering efficiency (nucleotide and amino acid recycling)
- Presence of cellular nucleases that degrade input DNA
- Proteases that degrade target protein
- Poor reproducibility
NTx has developed a fully recombinant, thermostable, reliable, and functional in vitro transcription/translation system for the production of biologics.
Compared to cell-based expression, cell-free (CF) production of biologics provides greater flexibility, faster response time, less energy, and minimizes facility footprints. CF production does not require dedicated facilities per strain/product and can be scaled throughout the commercialization process saving time and money.
NTxpress® is designed to offer high-quality linear scaling with compressed cycle time for product manufacturing. The NTxpress® platform requires limited upfront capital investment and can be adapted for a turnkey modular solution.
Our Recombinant In Vitro Technology
EXTRACT-BASED CELL-FREE EXPRESSION
- Cell extracts from E. coli, wheat germ, rabbit reticulocyte, insect cells
- Mostly circular DNA templates
- Non-improved T7-RNAP polymerase
- Energy regeneration based upon ATP present in lysate
- Limited run times
- Poor reproducibility
NTX CELL-FREE EXPRESSION
- Minimizes unwanted cellular metabolism
- Supports linear or circular DNA templates
- Efficient ATP regenerating system to supply sustained energy
- High reproducibility
- Generate target proteins in less than a day