mRNA Drug Product Manufacturing

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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

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RNA Drug Product Products & Services
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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.

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