How has Ntensify™ technology revolutionized mRNA production?
Quantoom Biosciences has just launched Ntensify™, the world’s first continuous mRNA production technology that will revolutionize the entire mRNA creation workflow.
How it all started
In 2013, two biotech entrepreneurs, José Castillo and Hugues Bultot, founded Univercells with one mission: to make biology for all. Their belief in the potential of technology to break down barriers to large-scale biological production fuels their ambition to make these drugs accessible to people who can’t afford them.
Fast forward to 2021, and the world is facing a global health crisis with the Covid-19 outbreak. In the search for solutions, RNA-based vaccines have emerged as a promising option. However, large-scale production of RNA vaccines poses significant challenges. This prompted José Castillo to found Quantoom Biosciences (‘Quantoom’) in June 2021, with the aim of revolutionizing mRNA production. With the promise of delivering the highest quality mRNA at a lower cost, the Quantoom platform has the potential to democratize access to RNA-based therapies, including vaccines.
Less than two years after the start, Quantoom Production Technology Line, Ntensify, is now ready for commercialization. This breakthrough platform has the potential to transform the production of mRNA-based therapeutics and make them more accessible to patients worldwide.
A latest webinars hosted by Quantoom provides an opportunity to learn more about the technology and benefits behind Ntensify.
Current bottlenecks in mRNA vaccine development and how Ntensify overcome them
There are three main barriers to mRNA production:
- Optimal mRNA sequence design is complex and it takes a lot of time to identify and select the most promising mRNA candidates.
- The development of suitable production processes is complex and involves the use of special reagents which must be carefully selected and tested to ensure high performance.
- Demanding improvement and process validation is required for clinical trials and commercial production. This involves ensuring that the manufacturing process can be scaled up effectively without compromising the quality of the final product.
Intensify is a low-trace, automatic production technology that can be synthesized and purify mRNA from research scale to production scale. When using Quantoom reagents, results are maximized without sacrificing quality or cost. The input material is DNA, and the output is RNA ready to be formulated. Ntensify also provides customers with optimized processes, ready-to-use one-off products, and reagents to assist in the development of vaccines or mRNA therapies.
Redesigned and optimized in-vitro the transcription process (IVT) was co-developed with eTheRNA, enabling continuous production in a 20mL batch sequential fashion. This approach avoids upgrades, which are known to carry associated risks. Impurities are limited, reducing the purification process to one step. Additionally, the process is mRNA-agnostic construction, making it a versatile solution.
To ensure optimal performance, Quantoom offers pre-prepared ready-to-use reagent mixtures at the correct concentrations, volumes and ratios, in the correct buffers. Single-use products have been designed so that customers can benefit from a hassle-free process with increased efficiency.
Finally, Ntensify has a very small footprint, replaces all steps in the manufacturing process, and incorporates single-use products to provide an optimized process.
Ntensify is available as a series of three models to meet the different needs at each stage of the mRNA production journey. Mini Ntensify is ideal for research and development, screening up to 192 constructs or for small-scale (mg) production of one specific mRNA construct required for in-vivo studies. Ntensify midi is suitable for clinical trials and mid-capacity GMP-grade production, providing 1-5g of RNA a day and 7 million doses a year (at 50 µg/dose). It is GMP compliant and soon upgradeable to Ntensify maxi which offers a drastically increased continuous production of over 50 million doses per year (at 50 µg/dose).
Benefit from the Ntensify Line of Technologies
Ntensify simplifies mRNA programming, which has several benefits. First, it eliminates risk by providing performance above standards for yield and quality, which have been demonstrated on mRNA (1,000 – 4,000 nucleotides) and saRNA (up to 11,000 nucleotides). Second, it accelerates time to market by enabling faster screening of candidates and µg for multi-kg mRNA production without the need for process optimization. Lastly, Ntensify offers cost efficiency, reducing capital outlay as well as operational costs for reagents.
Case study
Using Ntensify to produce 50 million doses of mRNA vaccine (50 µg/dose/year) compared to the conventional 40L approach:
Ntensify maxi can produce 50 million doses of mRNA vaccine per year, in just 42 batches:
- Ntensify maxi requires 3 times lower IVT volumes (13L instead of 40L) for the same volume of final product, resulting in reduced reagents required (limiting reagents, enzymes, media) and requiring only one purification step. This optimized process results in significant cost savings.
- By producing at 20 mL and operating in sequential continuous mode, Ntensify maxi was able to save 15 months and ~7.5 million euros in materials and FTE costs. No need for time-consuming scaling up of benchwork.
- Ntensify’s automated IVT and one-step purification results in lower batch failure rates and annual operating cost savings of >6 million euros.
- Ntensify’s compact design allows it to fit into one 30 square meter container. The smaller vaccine facility saves an additional CAPEX of 4 million euros, eliminating the need for Media and Buffer preparation space and requiring less warehouse space. Overall, the production of 50 million doses of mRNA vaccine can be done in a 300 m2 facility instead of an 800 m2 facility.
DNA is an essential initial component for the manufacture of RNA. Quantoom has met this need by providing its customers who acquire Ntensify with DNA on-demand services. This service includes plasmid DNA engineering and amplification parameter screening, producing pure DNA for use in Ntensify systems. DNA can be provided in less than 6 weeks on scales from µg to 70 mg and comes with certificates of analysis, including NGS, DNA integrity, purity, endotoxin testing and more.
Ntensify has the potential to benefit companies in the development and production of vaccines for both human and animal health. Biopharma companies already involved in developing vaccines may find that Ntensify gives them an edge over their competitors, allowing them to accelerate their research and development efforts. Development and contract manufacturing organizations (CDMOs) may also find that the technology allows them to differentiate their services.
Likewise, biotechnology companies seeking to bring their first promising vaccine candidates to market may be able to speed up their development process.
Quantoom stands out from other companies in the field as the only company capable of supplying equipment, single-use plastics, reagents and related DNA services for the continuous production of mRNA from µg to kg in a single small footprint instrument.
Contact Quantoom at bd@quantoom.com and join our first customer to surpass competitors in your industry.
Here is a link to webinars And Click here to discover more about Ntensify.
Image courtesy: Quantoom Biosciences, Shutterstock
