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.
1. Templates
Various grade and type of templates
Customer or sourced non GMP plasmid
PCR production by Eurogentec
GMP plasmid produced at Eurogentec
1b. Plasmid linearization
Production of template by linearization of any plasmid DNA.
2. GMP IVT-mRNA production
Transfer | Scale-up | Development | Optimization
Enzyme based synthesis for clinical trials and Process Performance Qualification (PPQ) for commercialization (0.5 to 50g)
- GMP or non-GMP enzymes
- Modified or natural ribonucleotides
2b. Co- or post- transcriptional modification
Transfer | Development | Optimization
RNA modifications for mRNA:
- ARCA, Clean cap®
- Vaccinia Capping Enzyme
- PolyA polymerase
3. Purification methods
Transfer | Development | Optimization
- Precipitation
- TFF
- Chromatography
4. QC methods
Transfer | Development | Optimization
- UV
- RT-PCR
- HPLC
- MS
- AGE
- Sequencing
- ELISA
- qPCR
- CGE
- Dot Blot
- endotoxin and residuals measurements
5. Drug substance
- GMP manufacturing of Drug Substance/API
- QC Release
- QA Review and release
- Stability studies
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.