mRNA Production | Aldevron

High-quality, scalable mRNA production meeting a wide range of requirements

As mRNA programs develop, quantity and quality requirements increase. Aldevron helps you advance to the next stage, where larger lot sizes, increasing levels of quality oversight and lot-to-lot consistency are required.

mRNA Process Ill 2

Aldevron produces high-quality mRNA to your specifications using scalable processes capable of delivering milligram to multi-gram quantities. Aldevron can also provide high-quality enzymes and linearized plasmid DNA for your in-house mRNA synthesis requirements.

Learn more about Aldevron's mRNA support

Benefits of mRNA Services

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. Features of our service include:

Process Scalability and lot-to-lot consistency	✔
Post-transcriptional and co-transcriptional capping options	✔
Base-modified NTP options	✔
Standard and custom QC assays	✔
Process enzymes and DNA template	✔
Multiple complementary services	✔

We have a wide range of experience in supplying clients with products at the appropriate quality level for each program stage. With Research Grade and GMP-level services, we can support your project from discovery through clinical and commercial stages of development. Our approach is tailored to fit your program requirements.

QC Testing Panel

We provide comprehensive testing for critical attributes such as purity, identity, concentration, total residual protein content, residual DNA template, residual endotoxin content and bioburden. Based on the USP recommendations (released in March 2022) and other regulatory guidance, we are dedicated to meet the highest standard for RNA production and provide guidance to qualify material for our clients’ needs.

Table 1: Quality Attributes and Methods Used for mRNA Drug Substance

Quality Attribute	Attribute	Method
Identity	Sequence Confirmation	RT-Sanger Sequencing
Identity	Identity - UTR	RT-PCR
Content	RNA Content	UV (SoloVPE)
Potency	Activity Assay	In vitro Transcription Assay
Purity/ Integrity	% Intact and fragment mRNA	IP-RPLC, Fragment Analyzer
	5’ capping efficiency	Malachite Green, UPLC, CE, BLI
	3’ poly(A) (% or length)	UPLC, CE, BLI
Impurity	Product Related impurities – dsRNA	Immunoblot, ELISA, BLI
	Process Related impurities - Residual Protein	Nanoorange, Cygnus HCP ELISA, process specific ELISA
	Process Related impurities - Residual Template	qPCR
Safety	Endotoxin	MCS
Safety	Bioburden	USP<61>

Complementary Products and Services

Supercoiled and linearized plasmid DNA manufacturing
Cas9, from Research Grade through GMP

mRNA Production Support
We manufacture the IVT enzymes and linearized plasmid DNA used to produce your mRNA under the quality level best fitting your project.

Aldevron mRNA services provide scalability, raw material and process controls, raw material cost control and RG-to-GMP transferability, ensuring consistent quality and affordability. We also can support the majority of your project requirements for other reagents directly or indirectly tied to your mRNA portfolios with our complementary platform services and products.

mRNA FAQ

Why choose Aldevron services versus an off-the-shelf kit?
When projects require larger quantities, consistent quality and high levels of purity, kits for mRNA production have limitations. With our services, these and other project requirements are met through a dedicated manufacturing platform, ensuring delivered products meet your specifications.

Where can I start with Aldevron?
The most common starting point is a plasmid DNA template. We will scale up, linearize and use in mRNA manufacturing. We offer our clients the flexibility to find a production process that works best for their application.

Can Aldevron make modifications to the mRNA product?
Yes, Aldevron has capabilities for 5' and 3' modifications to the mRNA product, including enzymatic capping and poly(A) tailing. Aldevron can also incorporate modified ribonucleotides as required for your specific project.

Who can I talk to about my specific project?
We have several experts on staff who can work with you to develop a plan that fits your project requirements and specifications. Contact us to connect with an expert.

Need to know more?
We’re ready to help. Contact us to set up time with Aldevron experts to discuss our processes and learn what sets our mRNA services apart.

Related Services

IVT Enzymes
Our IVT enzymes can be custom manufactured to meet requirements for construct design and formulation in batch sizes ranging from milligram to multigram scale.

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Linearized Plasmid DNA
From milligram to multigram quantities, we provide linearized plasmid DNA using a variety of enzymes with advanced purification techniques.

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DasherGFP® mRNA - Royalty Free
DasherGFP mRNA encodes an royalty-free, fluorescent protein optimized for expression in mammalian cells. It mimics mature mRNA with 5’ Cap 1 structure and 3’ poly(A) tail, and it is ideal for studying transfection and expression using a variety of assays.

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