Magnetic Bead-Based Solutions for mRNA Production

Accelerating the development and manufacturing of mRNA vaccine and therapeutics requires simple workflows with all inputs optimized for product needs. The demand for high-quality mRNA purification and synthesis must be met with flexible and scalable production solutions. Invitrogen Dynabeads Streptavidin for In Vitro Transcription and Invitrogen Dynabeads Carboxylic Acid for RNA Purification are specifically designed for optimal mRNA production.

• Flexibility—choice of synthetic or plasmid DNA template for mRNA IVT for greater flexibility of mRNA design
• Efficiency—reuse the DNA template up to six times, minimizing plasmid prep and reducing hands-on time and risk of transfer of bacterial host DNA
• Scalability—swap from manual to fully automated workflow to match required scale
• Minimized footprint—enables modular manufacturing to cost-effectively match required scale (increase or decrease)
• Support—platform designed for optimal product quality and regulatory support, including published data and technical support for vaccine development and manufacturing
• Quality—ensure a safe, flexible supply of magnetic beads for vaccine developers, from development to commercial manufacturing scale, without incurring extra time or costs from switching technology or raw materials

An innovative solution facilitating the re-use of DNA template, minimizing the effort needed for plasmid preparation whilst maximizing the mRNA productivity in scale ranging from µg to g quantities of mRNA.

RNA is synthesized using a biotinylated DNA template of choice, amplified through PCR, immobilized to Dynabeads Streptavidin for In Vitro Transcription. The immobilized template can be reused in the next IVT reaction (at least six times).

Cell culture volumes will be approximately 10,000 times smaller than traditional In Vitro Transcription (IVT) workflows. The highly efficient Dynabeads IVT process delivers superior quality mRNA in scalable quantities that can flex quickly and easily according to your needs.

Synthesized mRNA is captured at high quality in a volume of choice in a simple bind-wash-elute process.

Our proprietary magnetic bead technology, experience, and capabilities at your fingertips help to accelerate the commercialization of your mRNA vaccines and therapeutics by streamlining your development and manufacturing process, from prototype batches to bulk manufacture, providing reassurance on both bead performance and security of supply.

With 35+ years' experience in designing, developing, and manufacturing paramagnetic beads to internationally recognized quality standards, our Dynabeads specialists have collaborated with leading biotech, pharma, diagnostic, and healthcare companies, providing optimized and validated Dynabeads under custom OEM supply arrangements.

By working with mRNA production solutions, drug developers and vaccine manufacturers gain access to unique solutions for mRNA synthesis and purification with optimized workflows and flexible supply of rigorously controlled high-quality products. The products are specifically designed for this purpose, enabling seamless and GMP-compliant scale-up of mRNA production—from pre-clinical and toxicology studies to process development and optimization to clinical and commercial manufacturing.

Invitrogen Dynabeads Streptavidin for In Vitro Transcription and Invitrogen Dynabeads Carboxylic Acid for RNA Purification are supported by a comprehensive quality system and documentation, including:

• Manufacturing in compliance with ISO 20399, ISO 13485, and 21 CFR820
• Animal origin–free (AOF) manufacturing process/equipment and raw materials 
• Validated manufacturing processes and analytical methods
• Product-specific stability data
• Impurity profile
• Verified compendial test methods, where applicable 
• Manufactured in β-lactam–free facilities
• Quality support documents available including CoA, COO, TSE/BSE statement, nitrosamine statement, melamine statement, etc.