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GMP IVT RNA

GMP IVT RNA

RNAs are molecules of great interest and are considered as promising tools for gene editing and therapy. Unfortunately their chemical synthesis has some limitations. In vitro transcription is the method of choice for the production of long and stable RNA molecule for therapeutics usage.


Why choose Eurogentec for your RNA project


Since 1994, Eurogentec has been a leading GMP accredited manufacturer of biologics for clinical trials and commercialization. In addition, our company has high expertise in custom RNA synthesis under RNase free conditions for R&D and IVD uses. With an extensive knowledge in oligo synthesis and therapeutics manufacturing, Eurogentec has decided to invest in cutting edge material and clean room facilities for GMP IVT RNA production. Eurogentec’s Quality Management System can support the manufacturing of mRNA for therapeutic use (clinical phases), as CMO registered and accredited by the Belgian Health Authorities for this activity based on ICH Q7.

Our RNA service


In order to continuously improve our offer with state-of-the-art products, we have combined our expertises in GMP to our know-how in RNA synthesis to offer the GMP production of injectable in vitro transcribed RNA intended for RNA vaccine and RNA therapy. Our wide offer now includes manufacturing of up to 20g of custom RNA based therapeutics under GMP :

  • Long RNA,
  • Guide RNA (used for gene editing technique like CRISPR/Cas9, TALEN or ZFNs),
  • mRNA (with polyA tail and cap)

Our flexible service allows various grades and types of templates but also multi-enzymes choice for production and modifications.

GMP RNA manufacturing features



IVT RNA starting   IVT RNA Modifications   IVT RNA Process   IVT RNA Quality control
STARTING MATERIAL   MODIFICATIONS   PROCESS   QUALITY CONTROL
Customer or Eurogentec sourced PCR fragment
or
Plasmid DNA
(GMP or non-GMP)
  Various co- or post-transcriptional modifications
(including capping, poly-adenylation and modified ribonucleotides)
  Optimized and scaled up
by Eurogentec
  Full QC release
on Drug Substance

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.



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