mRNA-LNP Drug Product Manufacturing & Fill/Finish

Aldevron delivers experience

The COVID-19 pandemic accelerated interest in mRNA and self-amplifying RNA (saRNA) as vaccines and potential therapeutics. This required the building of capabilities and capacities to meet growing demand. Large vaccine manufactures called Aldevron for their needs and we were ready, having delivered high-quality mRNA for our clients since 2017, manufacturing >80 GMP batches, and supporting numerous IND submissions.

Advancing with Aldevron

Quality grades

Your goal is to change lives with a successful therapy or vaccine. There are many steps between your current program and that end goal. Working with a partner who can support you through the whole journey can significantly improve your chance of success. Aldevron offers research grade and full cGMP manufacturing services at scales and a complete range of process development services required to support your project through each stage from discovery to clinical trials and commercialization.

Preclinical - Commercial cGMP@4x

Technical Expertise

Aldevron provides a range of support during the process of high-quality mRNA drug product to your specifications using scalable and processes capable of delivering milligram to multi-gram quantities from sequence to vial. For your project requirements, we can customize the specific solutions with a range of tools to streamline your mRNA program.

We maintain consistent manufacturing conditions through all stages of the drug product process necessary to scale the mRNA drug substance and the signature nanoparticle formation to provide reproducible GMP-compliant mRNA-LNP manufacturing.

Learn More by watching our recent Webinar detailing our RNA-LNP drug product service under a single ecosystem. We demonstrate our scalable manufacturing capabilities within our dedicated facilities under a single quality workflow.

Drug product production

Your success is important to us, and our mRNA process optimization and manufacturing is complemented by decades of experience in plasmid DNA and enzyme development. Over time, we’ve found that one-size does not fit all. Working with Precision NanoSystems and Cytiva, we are prepared to support with any or all of your mRNA/saRNA development from template design through encapsulation and fill/finish. Having many years of experience, we are also technology agnostic to meet our clients specific needs. Therefore, we accept technology transfer at any stage of the mRNA drug product process and customize each project to fit each product's specific challenge, goals, and objectives.

mRNA Drug Product Production Solutions@4x

Learn more about each step in the complete solution for mRNA drug development and manufacturing process:

DNA Template Design & Production

mRNA Drug Substance Production

mRNA Drug Product

Optimization, screening, and development of a master cell bank for production of high-performance linearized plasmid template DNA for in vitro Transcription. A flexible system using Aldevron-made IVT enzymes, enzymatic or co-capping, and a purification strategy based on user requirements. LNP encapsulation is done with the support of Precision Nanosystems expertise. Closed aseptic filling of mRNA drug products that reduces risk and improve agility.
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Related Products
  • Cloning Backbones – Royalty and license free empty vectors contain the T7 promoter region for RNA production, with an option for encoded poly(A) available in one construct.
  • In vitro transcription & capping enzymes – Available as standard, in-stock products or custom manufactured to meet specific client requirements.
  • Nanoplasmid™ vectors – A next-generation, small cloning backbone that produces high-yield linear plasmid DNA templates by stabilizing the polyA tail.
  • DasherGFP mRNA – Study transfection and expression with an mRNA encoding an IP-free fluorescent protein which mimics mature mRNA with 5’ Cap 1 structure and 3’ poly(A) tail.


Breakthrough Campus

Fargo, ND

Plasmid DNA, mRNA, Protein manufacturing at cGMP & GMP-Source™ quality

Advance Campus

Fargo, ND

R&D, process development, manufacturing for early-stage research

Innovate Campus

Madison, WI

R&D, process development, manufacturing for early stage research

Impact Campus

Lincoln, NE

R&D, Nanoplasmid™ platform and cell line

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