mRNA Drug Product Manufacturing

Drug Product Manufacturing


The final step for the complete workflow: LNP formulations enable safe and efficient delivery into the cells and lead the way into a new era of genetic medicine. With over 50 cGMP lots generated, we now collaborate with Precision Nanosystem (PNI) expertise to provide critical components for mRNA therapies, further expanding our mRNA manufacturing by adding formulation capabilities to form the most comprehensive portfolio of products and services essential for mRNA vaccines and therapeutics development.

RNA lipid nanoparticle formulations

  • Incorporating PNI’s technology and expertise for large scale capacity 
  • Utilizes PNI’s lipid library, as an initial step for screening 
  • Leverage PNI’s NanoAssemblr® GMP System to obtain process consistency and encapsulation efficiency 
  • We optimize and scale based on customer needs through various stages of development and maintaining your desired specifications 


We are also a full service CDMO covering all phases from pre-clinical development to commercial manufacturing for LNP encapsulation. Our integrated mRNA CDMO platform provides manufacture capabilities for final mRNA drug products to advance your therapeutics. Our support through production, analytics, and regulatory will significantly decrease complexity and enhance speed to commercialization to help advance life-enhancing therapeutics.


Closed aseptic filling of mRNA drug products that reduces risk and improve agility. Under the Danaher umbrella, Aldevron is positioned to advance multiple candidates, including mRNA vaccines and therapeutics.


As important as flexible and scalable platform technologies are to the rapid development of mRNA-based therapeutics, they would not be possible without rapid, robust, accurate, sensitive, and scalable analytical technologies. Aldevron is position with partnership with Danaher Operation Companies, that include PNI, Sciex, and Cytiva, to provide clients the customizable analytical and method assay to validate the process of manufacturing from sequence to vial.

Quality Attribute 




Sequence Confirmation 

RT-Sanger Sequencing 

Identity - UTR 


Particle Sizing 



Concentration – Total RNA 


Concentration – Unencapsulated RNA 


% Encapsulation Efficiency (%EE) 

%EE = 1 - [Unencapsulated RNA] / [Total RNA] *100% 

Concentration – Total Lipid 

Lipid Analysis-UPLC-CAD 

Concentration – Individual Lipids  

Lipid Analysis-UPLC-CAD 

RNA:Lipid Ratio (N:P ratio) 

Total RNA (if>85% EE)/Total Lipid  


Capillary gel electrophoresis (CGE) 

Capillary gel electrophoresis (CGE) 


Activity Assay 

In vitro Transcription Assay 


Endotoxin (Endosafe®

USP <85> Kinetic Chromogenic LAL

Sterility USP<71> 

Sterility USP<71> 

Residual Solvent 


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