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GMP ENZYMATIC SYNTHESIS
GMP IVT RNA Service
In vitro transcription (IVT) is the method of choice to produce long and stable RNA molecules when chemical synthesis is not possible such as mRNA, guide RNA or long RNA.
We offer process development and GMP manufacturing of In vitro transcribed RNA (IVT-RNA) API for use in Tox studies and Human clinical trials.
Our expertise
In order to continuously improve our service offering in GMP therapeutics manufacturing we have combined our expertise in GMP biopharmaceutical manufacturing with our know-how in large scale oligonucleotide synthesis. This new GMP production service of injectable in vitro transcribed RNA is intended for use in RNA vaccine and RNA therapy human clinical trials.
Flexible service
Our service offering includes process development and GMP manufacturing of up to 10 g of your custom RNA. Our flexible service allows various grades and types of templates to be used (circular plasmid, linear plasmid, or PCR fragments) but also numerous strategies for capping and introduction of polyA tails.
Regulatory
All GMP material is produced in accordance to ICH Q7
Production of your RNA
Our flexible service allows various grades and types of templates, base modifications and capping strategies.
Long RNA
RNA too long for chemical synthesis
mRNA
With polyA tail and cap
Guide RNA
Used for gene editing technique like CRISPR/Cas9, TALEN or ZFNs
bp
Sequence lengths from
700 to 6000 nucleotides already tested
L
30 mL to 40L production scale
g
10 g GMP manufacturing scale
GMP IVT RNA workflow
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 RNA production
Transfer | Scale-up | Development | Optimization
Enzyme based synthesis for phase 1 clinical trials (10g)
- 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.