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 >70 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. 

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.

• RNA backbones and Nanoplasmid^TM backbone

• DNA template generation/optimization
• Plasmid DNA Production, purification, and linearization
• mRNA synthesis with in vitro transcription, capping and purification
• Analytics - Method development and validation
• Quality control and regulatory standards

• Lipid nanoparticles (LNP) encapsulation and fill/finish
  

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. 

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