Fast-track your RNA Therapy or Vaccine, without Compromising Quality
Unleash the innovative potential of Ntensify®, our advanced RNA production platform. From early R&D to commercial GMP, including LNP encapsulation, we are your trusted partner in advancing your RNA technology.
With the expertise of our dedicated RNA scientists, Exothera delivers preclinical and clinical manufacturing services and assists you in your CMC and industrialization strategy to deliver an optimal process fit for commercial manufacturing.
We support you every step of your product’s lifecycle. From process development to full-scale commercial manufacturing, our integrated approach simplifies management, reduces risks, and ensures consistency
Scalability
We use the Ntensify® platform from Quantoom Biosciences, which offers a streamlined approach to accelerate your RNA-based product development. Our automated and optimized process scales linearly from R&D to clinical and commercial scales, eliminating the need for additional process development.
Time and Costs
Traditional IVT approaches require time-consuming and cost-prohibitive scale-up process development as you move from R&D to the clinic to commercial. The Ntensify® platform is an automated, optimized process that eliminates the need for process development – fast-tracking your RNA product to the clinic at a fraction of the cost.
Product quality
The Ntensify® platform has been optimized to reduce process- and product-related impurities, consistently yielding high-quality RNA. Combined with our robust suite of in-house QC analytics, you can trust Exothera to provide reliably high-quality RNA at every stage of development.
Flexibility
We provide access to multiple capping technologies and LNP solutions along with your choice of uridine modifications to enhance the efficacy and safety of your RNA drug product.
Regulatory Compliance
We offer CMC consultancy services to guide you through the regulatory process for your RNA program. Our expertise helps streamline your regulatory submissions and increases the likelihood of successful approvals for your RNA-based therapeutics or vaccines.
Simplified Process Transfer
The Ntensify® platform is sequence-agnostic and compatible with various capping technologies, simplifying the adaptation of your current process. This allows seamless integration of your existing approach into our optimized platform, potentially boosting efficiency and enhancing product quality, regardless of your product’s development stage.
Average performances of Ntensify® process. Related to process parameters and RNA quality attributes.
RUO mRNA
• Reporter Genes
• Custom constructs with target yields starting at 200µg
Clinical Development
• Codon Optimization
• CMC consultancy for regulatory
• GMP-like production for tox screens and IND studies
Commercial Manufacturing
• Produce up to 5g purified RNA/day (up to 500k doses)
• LNP Encapsulation
• Fill and Finish Capabilities
Our analytical portfolio includes:
In-house DS
- Appearance, pH, bioburden, endotoxins: Compendial
- mRNA content: Nanodrop, Ribogreen
- mRNA identity: Nanopore sequencing
- % Poly(A) tail correct length/dispersity: Nanopore sequencing
- Residual DNA template: ddPCR
- Residual total protein: µBCA
- Expression of the target protein*: Cell-based assay
- Residual unincorporated nucleotides/caps: AEX-LC
- mRNA integrity: Capillary Gel Electrophoresis (CGE)
- % Capping efficiency: IP-RP-HPLC
- dsRNA: ELISA
- mRNA Aggregates/fragments: CGE
- Residual full-length antibiotic resistance gene: Nanopore
In-house DP
- Appearance, pH, visible particles, Osmolality, bioburden, endotoxins: Compendial
- Encapsulation yield: Fluorescence (Ribogreen)
- Lipid identity and content: HPLC-CAD
- LNP size, PDI, aggregates: DLS
- LNP charge: ELS
- mRNA integrity, aggregates, fragments: CGE
- RNA identity: Sequencing (Nanopore)
- In vitro Expression Assay*: HEK293 transfection-ELISA
- Endotoxins: LAL
- Residual solvents: Characterization
- Extractable volume: Compendial
*Read-out methods:
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- ELISA ( Sandwich, Indirect, and Direct)
- SDS-PAGE (Gel staining)
- SDS-PAGE with Western Blot read-out
- Multiplexing semi-quantitative SDS-PAGE with Western Blot
- Luminescence.
Type of antigen:
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- Viral
- Bacterial
- Plasmodiidae
- Insect
Outsourced
- mRNA identity: Sequencing (Sanger)
- % Poly(A) tail correct length/dispersity: LC-MS
- Residual Ethanol: GC-MS
- Sterility: Compendial
- Sub-visible Particles: Compendial
Looking for more information?
Speak to our Business Development Team and let’s discuss how Exothera’s RNA platform can empower your next breakthrough!
Speak to our Business Development Team:
Adam Thakore
Business Development Manager for Western EU, UK and PacAsia
Oliver Dezutter
Business Development Manager for Eastern Europe
Gavin Allsop
Senior Director and Head of Business Development at Exothera
Manuel Valdes
Senior Director BD for Eastern North America