mRNA Drug Product Manufacturing

Drug Product Manufacturing


This critical step for drug product manufacturing enables safe and efficient delivery into the cells and lead the way into a new era of genetic medicine. With over 100 cGMP lots generated, we now collaborate with Cytiva and Acuitas to provide critical components for mRNA therapies, further expanding our mRNA manufacturing capabilities by adding scalability of LNP encapsulation from research grade to GMP. Our goal was to form the most comprehensive portfolio of products and services essential for mRNA vaccines and therapeutics development to suit your program.


We are also a full service CDMO covering all phases from pre-clinical development to commercial manufacturing and offering multiple LNP encapsulation platforms. 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.


Aldevron has recently launched a comprehensive drug product platform which is supplemented by Fill/Finish capabilities via the SA25 Aseptic Filling Workcell from Cytiva within our GMP mRNA Suites to provide high-quality and characterized final drug product.

With this closed aseptic filling of mRNA drug products capability, we aim to reduce risk and improve agility. Under the Danaher umbrella, Aldevron is positioned to advance multiple candidates, including mRNA vaccines and therapeutics, all under one manufacturing and quality system to meet the need for final drug product manufacturing.


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 positioned with partnership with Danaher Operating Companies, that include Cytiva and SCIEX, to provide clients the customizable analytical and method assay to validate the process of manufacturing from sequence-to-vial.

Quality Attribute Attribute Method
Identity Sequence Confirmation RT-Sanger Sequencing
Identity - UTR RT-PCR
Particle Sizing DLS
Content Concentration – Total RNA UV
Concentration – Unencapsulated RNA UV
% 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
Purity Capillary gel electrophoresis (CGE) Capillary gel electrophoresis (CGE)
Potency Activity Assay Cell Based Assay
Safety Endotoxin (Endosafe®) USP <85> Kinetic Chromogenic LAL
Sterility USP<71> Sterility USP<71>
Residual Solvent UPLC

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