From its facilities at the University of Antwerp Science Park in Niel, the company can process and manufacture mRNAs in quantities ranging from research and preclinical batches to full GMP production batches for clinical trial supplies. . In providing these services, eTheRNA draws on extensive experience gained in developing its own portfolio of mRNA immunotherapies for the treatment of cancer and infectious diseases.
“We have expanded our contract manufacturing services in response to an increasing number of requests from third parties around the world,” commented Dr. Bernard Sagaert, vice president of manufacturing, eTheRNA. “With our two specially designed mRNA units, we have the optimal infrastructure to support mRNA-based projects, from the initial development and optimization of plasmid DNA to linearization, from in vitro translation, mRNA purification and quality control to industrialized production of BPF. We can support clients ranging from small academic groups we can partner with to established companies looking for GMP manufacturing capability.
The full range of services offered by eTheRNA include:
- Plasmid DNA – design and production of plasmid DNA adapted to customer needs.
- Research-grade RNA – mRNA, guide RNA, long RNA and dsRNA can be provided from 100 µg to gram scale and can include multiple constructs for screening purposes.
- BPF grade RNA – The medicinal substances mRNA, long RNA and guide RNA can be made by in vitro transcription in amounts ranging from 100 mg on a gram scale. Various upstream and downstream purification methods are available, including different capping and adenylation techniques and targeted purification techniques which include precipitation, column chromatography, double-stranded RNA reduction, filter filtration. tangential flow, reduction of bioburden and sterile filtration. Several APIs can be formulated into a drug product and sterile filling and finishing is available. GMP batch release is fully cGMP compliant.
Additionally, drawing on its own clinical trial experience, eTheRNA can assist clients in writing CMC files.