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.

Discover: Oligo dT18  |   PrimaS   |   SDVB   |   C4 HLD

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.

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.

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.

Contact Form

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.

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

Testimonials

“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

Read the News here

“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

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