ENZYMATIC SYNTHESIS
Custom mRNA manufacturing
Your trusted partner in mRNA production, supporting every stage of development. We provide custom mRNA manufacturing services through in vitro transcription (IVT). With deep expertise in mRNA synthesis and purification, we offer tailored solutions from discovery and screening to clinical trials and commercialization.
Your CDMO mRNA partner from
discovery to commercialization
We offer tailored solutions from discovery and screening to clinical trials and commercialization.
Whether leveraging our mRNA platform, your existing process, or a newly developed one, we
provide expert guidance to ensure the success of your project.
Research & Discovery
We produce IVT mRNA designed for early-stage drug development, supporting activities such as discovery phase research, proof-of-concept studies, and screening of new drug candidates. Our services include:
- Comprehensive screening services Our screening offering includes the production of RNA controls and research-grade mRNA for up to 20 molecules, with quantities up to 1 mg each.
- Scalable manufacturing process Thanks to our mRNA manufacturing platform, we ensure fast delivery and consistent quality.
Our process supports quantities from 10 mg to 500 mg at R&D scale, and is fully scalable, which makes it adaptable for GMP-grade production as your project advances.
Why Choose Eurogentec for your early-stage development?
- Rapid turnaround enabled by in-stock raw materials
- Flexible production volumes to match your research needs
- Seamless transition from research-grade to GMP-grade mRNA
Preclinical development
We support your preclinical development through the production of feasibility and engineering batches, paving the way toward GMP manufacturing.
Our mRNA manufacturing process is designed to accelerate the transition to GMP-grade production, ensuring efficiency and consistency from early development through to clinical supply.
We also work closely with customers to develop custom mRNA processes tailored to their unique project needs. For customers with an existing production workflow, we also offer process transfer services.
Clinical trials
With over 10 years of expertise in GMP mRNA manufacturing, we specialize in producing injectable-grade mRNA for vaccines, therapeutics, and gene editing drug substances, supporting seamless progression through clinical trials to commercialization.
Our GMP-grade capabilities cover batch sizes ranging from 0.5 g to 50 g, providing the flexibility needed to match the quantity needs of your project.
Commercialization
Eurogentec is your trusted CDMO partner for commercial mRNA production, with extensive experience in process validation, including Process Design (Stage 1), Process Qualification (Stage 2) and Continued Process Verification (Stage 3).
Our teams follow EMA and FDA guidelines to ensure regulatory compliance at every stage of manufacturing. We also provide full support for regulatory submissions, helping you prepare and compile documentation for health authority review with confidence and efficiency.
What is included in our mRNA services?
Our mRNA manufacturing service includes process development, plasmid linearization, and scalable IVT production of
mRNA Active Pharmaceutical Ingredients (APIs) using customer-provided or Eurogentec-sourced templates.
Template
Our flexible service supports a variety of template grades and types.
- Customer-provided or Eurogentec-sourced materials
- Includes circular plasmids, linear plasmids, and synthetic DNA
We also offer a plasmid linearization service, streamlining the process to ensure optimal results.
mRNA Manufacturing
Our scalable manufacturing process delivers tailor-made mRNA.
- IVT mRNA manufacturing up to 50g
- Incorporation of modified ribonucleotides
- Co- or post-transcriptional modifications, including:
- Capping
- Poly-adenylation
- Dephosphorylation
- Purification: precipitation, tangential flow filtration (TFF), and chromatography
Quality
Our downstream process ensures exceptional purity and quality.
- Quality Control: Offering comprehensive in-house QC packages and customizable testing options.
- Quality Assurance: ICH Q7 compliance for GMP RNA drug substance production for clinical trials.
Flexible mRNA manufacturing project
State-of-the-art facilities
Our facilities, located in Belgium, are designed to meet the demands of both small and large-scale research and GMP-grade manufacturing.
Our 4 GMP suites are equipped for production, purification, and comprehensive QC activities, with robust QA oversight and QP certification processes to ensure every batch meets the highest quality standards.
QC packages tailored to your needs
With a variety of QC packages and testing options, we ensure you can assemble a tailored QC strategy to meet your specific scientific and regulatory goals. We also support the development and transfer of custom QC tests upon request, offering maximum flexibility to accommodate your project. In addition, we can perform stability studies to help you assess the long-term performance and shelf-life of your products under various storage conditions.
Our R&D QC package includes the following analyses:
- Size
- Integrity
- Quantification
Additional quality controls can be performed upon request.
Comprehensive GMP Quality Testing
- Appearance
- pH
- Size
- Quantification
- Integrity
- Residual pDNA
- Residual Host Cell Proteins (HCP)
Ensuring mRNA Safety
Our safety package is designed to assess potential contamination risks, ensuring that mRNA products meet stringent safety standards.
This package includes:
- Endotoxin testing
- Bioburden testing
Advanced QC testing
For specialized needs, our optional QC tests cover advanced analyses including:
- Identity
- % Capping
- % Modified nucleotides
- Poly(A) tail length
- Residual enzymes
- dsRNA content
Expert support
Scientific
Support
Our team of scientific advisors is here to guide you in making the best decisions for your current project and long-term needs. We provide tailored recommendations to optimize your mRNA production while guaranteeing full GMP compliance by the end of the development process.
Project Management
We assign dedicated project managers who prioritize open and transparent communication at every stage. Their proactive and collaborative approach has been highly valued by our customers, facilitating a smooth and efficient partnership.
Quality
Management
Our Quality Management System ensures that every employee operates within the guidelines to produce and deliver GMP RNA drug substance in accordance with ICH Q7. Our GMP suites are equipped for production and purification with robust QA oversight and QP certification processes to ensure every batch meets the highest quality standards.
Why choose Eurogentec
for your RNA project?
Expertise
Decades of GMP experience with a multiproduct platform.
One single partner
Continuum from clinical to commercial supply.
Project support
Dedicated project managers and scientific advisors.
Fast manufacturing
Proprietary mRNA process for accelerated timelines.
Process validation
Following EMA and FDA recommendations.
Others CDMO services
Note: The non-infringement of any patents covering the operation of any process or the use of the product alone or in combination with other for use or sale of the products mentioned above is not warranted by Eurogentec. The customer has the sole responsibility of all and any use of Eurogentec’s products.