
mRNA Drug Product Manufacturing
Protecting what you’ve created. Fiercely formulated, reliably finished.
When bringing your mRNA drug product to market, you face critical steps such as LNP encapsulation, sterile fill/finish, analytical testing, and navigating regulatory approval. These stages require precision, expertise, and compliance with stringent standards.
Aldevron's comprehensive services are designed to support you through these later steps, ensuring high-quality mRNA drug substance is effectively transformed into a market-ready mRNA drug product. Our tailored solutions and regulatory expertise under one roof and quality system allow you to confidently manage these complex processes and achieve successful product approval.
Large scale LNP process and encapsulation
Aldevron has expanded mRNA manufacturing capabilities by adding LNP encapsulation from research grade to cGMP, with support for multiple LNP encapsulation platforms, to provide manufacturing capabilities for final mRNA drug products. With our partners Cytiva and Acuitas supporting the optimization of your LNP formulation, Aldevron offers production, analytics, and regulatory support to significantly decrease complexity and enhance speed to commercialization to help advance life-enhancing therapeutics.
Fill/Finish
Aldevron has a comprehensive drug product platform supplemented by Fill/Finish capabilities via the SA25 Aseptic Filling Workcell from Cytiva, installed in our cGMP mRNA suites to provide high-quality and characterized final drug product.
With this closed aseptic filling of mRNA drug products capability, we 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.
Analytics
Rapid, robust, accurate, sensitive, and scalable analytical technologies are required for the development of mRNA-based therapeutics. Aldevron has partnered with other Danaher companies, including Cytiva and SCIEX, to provide clients with customizable analytical and method assays to validate the process of manufacturing from sequence to vial.
Quality Attribute | Attribute | Method |
Identity | Sequence Confirmation | RT-Sanger Sequencing |
Identity - UTR | RT-PCR | |
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 | 5’ capping efficiency | RP-LC-MS |
Integrity | Particle Sizing | DLS |
RNA Intactness | Capillary Electrophoresis | |
Potency | Activity Assay | Cell Based Assay |
The Aldevron Advantage
Consider all the variables that you’ve reviewed and tested. How many decisions have you made from concept up to this point in your program development journey? From optimized cloning backbones to sterile fill/finish and full analytics, Aldevron works with you every step of the way. Support from a single, experienced partner simplifies the process, and brings the competence and stability required for long-term success.

DNA design and optimization
Specialized products and services for mRNA design and development that can significantly reduce supply-chain risks, shorten lead times, and enhance quality.

RNA drug substance manufacturing
Flexible, scalable process produces high-quality RNA tailored to your specifications, delivering quantities from milligrams to multi-grams.

LNP encapsulation
Support for multiple LNP encapsulation platforms for final mRNA drug products. Production, analytics, and regulatory support from a single partner will significantly decrease complexity.

Fill/Finish
Fill/Finish capabilities via the SA25 Aseptic Filling Workcell from Cytiva within our cGMP mRNA suites to provide high-quality and characterized final drug product.

Analytics
Aldevron has partnered with other Danaher companies, including Cytiva and SCIEX, to provide clients the customizable analytical and method assays to validate the process from sequence-to-vial.

Regulatory support
Having supported over 1,000 clinical trials across modalities, our direct connections and first-hand experience can support you from start to finish, from idea to commercialization, from IND application to clinical trial and beyond.
With decades of experience, Aldevron can propel your gene therapy projects forward, paving the way for groundbreaking therapeutic advancements
Delve into the meticulous process of developing RNA drug substances. Discover how Aldevron ensures purity, quality, and scalability through advanced manufacturing technologies and rigorous quality control measures.
Resources
- mRNA Services (PDF)
- Comprehensive Pathway to Seamless Scale-Up of mRNA Drug Product Manufacturing (PDF)
- Unlock the Power of mRNA with Aldevron’s Analytical Testing (PDF)
- Alchemy™ Cell-free DNA Technology (PDF)
- Revolutionizing mRNA Manufacturing with Alchemy™ Cell-free DNA Technology (Webinar)
- Mastering the Path: Developing Processes for Successful Clinical-Grade mRNA Manufacturing (Webinar)
- Comprehensive GMP Manufacturing of mRNA-LNP Drug Products: Sequence-to-Vial (Webinar)
- How a Sponsored CMC Platform Accelerates mRNA Projects to the Clinic (Webinar)
- mRNA/saRNA Manufacturing: Considerations to Accelerate the Path to Clinic (Webinar)
- Q&A series with Aldevron CSO, Venkata Indurthi, Ph.D. (PDF)
- Topic 1: Program Development & Support
- Topic 2: Synthesis Process & Methods
- Topic 3: Production & Manufacturing
- Topic 4: Analytics & Testing
- Topic 5: Therapeutic Delivery & Applications