One mRNA Purification Process: From R&D to Development to Manufacturing

One-step or multi-step chromatographic purification to achieve the desired purity level. Explore CIM® chromatographic solutions for the entire production process, from DNA template to purified mRNA.

A chromatographic toolbox can overcome challenges in process design. Templated or enzymatic polyadenylation, vaccinia capping or capping analog? The toolbox with four unique ligands offers flexibility and benefits in purification:

Fewer unit operations: apply IVT material to monolith without buffer exchange.
High flow rate and high binding capacity with open-channel CIM® monoliths.
Option to re-use monoliths, or implement them into a single-use platform.

See pDNA purification resources for production of high quality DNA template.

Capture from IVT

Oligo dT18

Affinity

Polyadenylated mRNA capture

Elution in water

Swiper

Multimodal

Capture all RNA

Elution in neutral pH

Alternatively, CIMmultus PrimaS® can be used instead of CIMmultus Swiper for capture.

Polishing

SDVB

Ion-pair RP

dsRNA removal

Room temperature, low pressure

C4 HLD

Hydrophobic

Aqueous conditions

Protein removal

The go-to alternative when capture by affinity isn't feasible

The CIMmultus Swiper is a breakthrough in RNA purification, efficiently handling diverse RNA types like mRNA, saRNA, circular RNA, and non-coding RNAs. It's especially effective for non-polyadenylated RNA, where traditional methods fall short.

Learn more

The Same Process at Any Scale

The same mRNA toolbox from μg scale to kg scale. Start from the beginning with μ-scale and high throughput purification. Transfer your workflow from discovery R&D to development and commercial manufacturing with full GMP compliance.

Immobilisation of Custom Oligo Sequence

Use an RNA-specific oligo sequence for affinity capture. Custom and proprietary affinity tags can be immobilised on the monolith to improve purity of the product.

Unsure How to Get Started?

Use an RNA-specific oligo sequence for affinity capture. Custom and proprietary affinity tags can be immobilised on the monolith to improve purity of the product.

The toolbox can fit different RNA modalities: from mRNA, saRNA (self-amplifying RNA), to emerging RNA modalities, such as circular and long non-coding RNA.

Working without poly-A tail? Try multimodal or custom affinity monoliths for capture.

A Purification Process as Unique as Your mRNA

Sartorius’ state of the art facilities in Ajdovščina, Slovenia provide on-demand training activities and process development services for mRNA. Use our contact form to get in touch.

mRNA Services

Monitor and Optimize Your Process With mRNA-Specific Analytics

PATfix mRNA Analytical Platform combines an at-line LC system with the monolith technology and pre-validated methods. Specifically set for non-chromatography expert to run analytics in process lab in only 5-15 minutes.

Monitoring IVT reaction components and mRNA product quality with three orthogonal analytical methods
Increasing IVT yield while cutting capping reagent cost by half

“We are very pleased to be collaborating with BIA Separations / Sartorius in developing and tech-transferring optimized mRNA vaccine manufacturing processes. When time is of the essence, it is crucial to be able to rely on key partners whilst maintaining the highest level of quality in every aspect of our work. We are also very proud that our team was able to produce two kinds of genetic vaccines (DNA and mRNA) and we look forward to expanding our partnership with the BIA Separations’ team on future projects.” – Hong Thai Pham, CEO, BioNet

“We use BIA Separations Monolith columns for the purification of our mRNA drug substance. The Monolith columns come in multiple sizes to meet our needs from small scale product development work to large scale cGMP manufacturing runs. We have found the Monolith columns to provide high throughput and high purity while being very robust and reliable. In addition, BIA Separations has top notch customer service that never fails to impress.” – Greg Kubczak, Director of Technical Services and Manufacturing, Arcturus Therapeutics

“The human capital at BIA is amazing. People are dedicated; it’s not only the column, it’s basically the people behind it that can help you improve your production and analytics at every step. From a CMC standpoint, this is super important. I don’t think there is any other company that can do that. The know-how at BIA is really amazing, and the ability to look at pure products at the end with analytical tools is what makes makes them different from everyone else.” – Dan Peer, Vice President for Research and Development, NeoVac

The PATfix pDNA analytical platform package was helpful in getting the plasmid analysis running with validated protocols built-in the system. We have also been utilising PATfix for the analysis of IVT mRNA with validated protocols provided by Sartorius BIA Separations. We have been getting consistent and reliable results with high-throughput work processes made possible by the at-line implementation of the PATfix platform. I am happy with the system as it is easy to use, reliable and the support provided by the highly knowledgeable team at Sartorius BIA Separations and Sartorius has been excellent. I am looking forward to continuing working with the PATfix platform and the Sartorius BIA Separations team with their ongoing developments in providing high-quality analytical products. – Dae Jong Han, Research Specialist (Analytics), BASE mRNA Facility, Australia.