ENZYMATIC SYNTHESIS
mRNA manufacturing process
Eurogentec provides end-to-end GMP mRNA manufacturing through a multi-step workflow designed to deliver high-quality mRNA drug substance, from plasmid linearization to final filtration and aliquoting.
What are the key steps in our GMP
mRNA manufacturing process?
The mRNA manufacturing process is a multi-step workflow designed to produce high-quality,
functional mRNA for research and therapeutic applications.
1. DNA template
We work with a wide range of DNA template types and quality grades, including customer-provided or Eurogentec-sourced materials.
Supported templates include plasmid DNA and synthetic DNA, available from RUO to GMP grade.
To further streamline the workflow and optimize transcription efficiency, we also offer plasmid linearization services.
2. IVT RNA Synthesis
We manufacture mRNA at multiple scales using single-use bioreactors, supporting flexible and scalable GMP manufacturing with capacities of up to 50 grams per batch.
Our mRNA synthesis platform supports co-transcriptional capping technologies, including Cap0 and Cap1, together with unmodified or modified nucleotides tailored to your application requirements.
3. Post- transcriptional modification
Phosphatase treatment
Phosphatase treatment reduces immunogenicity associated with 5’-triphosphate ends on uncapped mRNA and improve the safety profile of your mRNA products.
Enzymatic capping with Vaccinia Capping Enzyme
As an alternative of Synthetic Cap Analogs, we can also employ the Vaccinia Capping System to ensure efficient capping, enhancing mRNA stability and translational efficiency.
Poly(A) Tail
Using poly(A) polymerase offers a greater flexibility in tail length, enabling to meet specific functional needs.
4. Purification
Our capabilities include:
- Chromatography
- Precipitation
- Tangential flow filtration (TFF)
This offer allows us to tailor purification methods to specific project requirements.
5. Final filtration & aliquoting
To ensure product safety and quality, a final 0.22 µm filtration step is performed to remove potential microbial contaminants prior to drug substance (DS) aliquoting.
For GMP-grade mRNA manufacturing, filtration and aliquoting are conducted under a Grade A laminar flow hood in compliance with GMP regulatory standards.
FAQs
mRNA manufacturing can start from different DNA template formats, including plasmid DNA and synthetic DNA. Depending on the project requirements, templates may be customer-provided or sourced directly by the manufacturer. GMP-grade and RUO-grade materials may also be available depending on the intended application.
Plasmid linearization helps improve transcription efficiency and supports the generation of uniform mRNA transcripts during in vitro transcription. Properly linearized DNA templates can contribute to higher product consistency and manufacturing robustness.
GMP-manufactured mRNA is widely used in vaccine development, cancer immunotherapy, protein replacement therapies, gene editing workflows, and cell therapy applications.
Yes. Manufacturing workflows can often be adapted based on project requirements, including template type, capping strategy, modified nucleotides, purification methods, and batch scale.
Important considerations include GMP compliance history, manufacturing scalability, analytical capabilities, process flexibility, supply chain reliability, and experience with mRNA process development and regulatory support. you can learn more about this subject on our blog article.
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.