From its facilities on the Antwerp University Science Park in Niel, the company can develop processes and manufacture mRNA in amounts ranging from research and pre-clinical batches to full GMP production lots for clinical trial supplies. In providing these services, eTheRNA leverages extensive experience gained in developing its own pipeline of mRNA immunotherapies for the treatment of cancer and infectious disease.
“We have extended our contract manufacturing services in response to a growing number of requests from third parties from around the world,” commented Dr. Bernard Sagaert, VP manufacturing, eTheRNA. “With our two purpose-built mRNA-units, we have the optimal infrastructure to support mRNA-based projects from initial plasmid DNA development and optimization, through linearization, in-vitro translation, mRNA purification and quality control to industrialized GMP production. We can support customers ranging from small academic groups with whom we can partner through to established companies looking for GMP manufacturing capacity.”
The full range of services offered by eTheRNA includes:
- Plasmid DNA – design and production of plasmid DNA tailored to customer requirements.
- Research Grade RNA – mRNA, Guide RNA, Long RNA and dsRNA can be supplied from 100 µg to gram scale and can include multiple constructs for screening purposes.
- GMP Grade RNA – mRNA, Long RNA and Guide RNA drug substances can be manufactured by in-vitro transcription in quantities from 100 mg to gram scale. Various upstream and downstream purification processes are available including different capping and adenylation techniques and purpose-based purification techniques which include precipitation, column chromatography, double stranded RNA reduction, tangential flow filtration, bioburden reduction and sterile filtration. Multiple APIs can be formulated into a drug product and sterile fill & finish is available. GMP batch release is in full accordance with cGMP.
Also, by drawing on its own experience with clinical trials, eTheRNA can provide support to customers in CMC file writing.