Thermo Fisher Scientific Introduces Customized Dynabeads Solutions for Scalable mRNA Production
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The Dynabeads™ Streptavidin for In Vitro Transcription and Dynabeads Carboxylic Acid for RNA Purification solutions support scalable GMP-grade synthesis and purification of mRNA for vaccine development and manufacturing. The fit-for-purpose solutions, combined with Thermo Scientific™ TheraPure™ GMP* portfolio of nucleotides and enzymes, help provide a simplified workflow to enable mRNA companies to accelerate from development to commercialization.
Dynabeads Streptavidin for In Vitro Transcription are designed for simple solid-phase in vitro transcription (IVT) of cell-free mRNA. The beads facilitate the re-use of DNA template up to six times, helping minimize the effort needed for plasmid preparation while enhancing mRNA productivity in scale ranging from μg to g. RNA is synthesized using a biotinylated DNA template of choice, amplified through PCR and immobilized to Dynabeads Streptavidin for IVT.
Dynabeads Carboxylic Acid for RNA Purification enable high-quality, synthesized mRNA capture in a volume of choice through a simple bind-wash-elute process.
The Dynabeads mRNA production solutions can be used in combination with any of the Kingfisher family of instruments.
“With our Dynabeads technology, Thermo Fisher Scientific has been a market leader in magnetic beads for decades. Our new mRNA production solutions enable us to further support mRNA vaccine development and manufacturing to help our customers respond to epidemic events and deliver new mRNA vaccines flexibly and at desired scale,” said Malin Karlsson, senior director and general manager, CEP & Beads, Thermo Fisher Scientific.
Key Applications: mRNA production for mRNA vaccine drug development and vaccine manufacture
- Flexibility: Choice of synthetic or plasmid DNA template for mRNA IVT enables increased flexibility of mRNA design.
- Efficiency: Ability to reuse the DNA template up to six times helps minimize plasmid prep while reducing hands-on time and risk of transfer of bacterial host DNA. In addition, the solutions require 10,000 times less cell culture volume than traditional IVT workflows.
- Scalability: Users can swap from manual to fully automated workflow to match the required scale.
- Minimized footprint: The solutions enable modular manufacturing to cost-effectively scale up or down.
- Support: Designed for optimal product quality and regulatory support, including published data and technical support for vaccine development and manufacturing.
- Quality: Safe, flexible supply of magnetic beads designed for GMP-grade workflows saves time and costs, helping eliminate the need to switch technology and raw materials on the journey from development to commercial manufacturing.
*“TheraPure GMP” refers to the quality level of the raw, ancillary, or starting materials to be used for further manufacturing. TheraPure GMP products are manufactured in facilities with ISO 9001–certified quality management systems that operate in accordance with relevant good manufacturing practice (GMP) principles, as outlined in ICH Q7 or equivalent guidance documents or standards.