mRNA Development and Design
Complete Solutions for mRNA Drug Development and Large-Scale Manufacturing
Aldevron has demonstrated expertise as a manufacturer of plasmid DNA templates for in vitro transcription (IVT) in mRNA synthesis. To further support mRNA production, we’ve expanded our portfolio to include IVT enzymes offered in multiple quality grades—from research to cGMP—helping clients progress from discovery through clinical development.
This integrated approach delivers key advantages: reduced supply-chain risk, shorter lead times, and consistent quality across stages. mRNA production can start from an electronic DNA sequence or a supercoiled plasmid provided by the client, with options for capping, tailing, and chemical modifications to meet diverse application requirements.
DNA Template Development for mRNA Production
Aldevron's state-of-the-art quality systems ensure your material will meet your specifications. From synthesis, cloning, verification, restriction digestion, strain selection, cell banking, and plasmid preparation, we strive to meet any specification required from research through clinical applications.
Strain Selection and Optimization
- Test 2-3 E.coli strains
- Generate a design space for process conditions (multiple temp and media components)
- Develop a small-scale model for full-scale production
cGMP Master Cell Bank generation
- Generate cGMP cell bank that could be used for research and cGMP projects
- Enable faster project execution during late state clinical phases
Aldevron Advantage
Aldevron provides several options for RNA backbones to clone in your gene of interest to provide simplicity and effective production of mRNA. These backbones have optimal UTR configurations, and we provide the needed assays for validation through the manufacturing process.
pDNA Production
Aldevron offers two different services for plasmid production with specific quality and documentation, such as when your materials are destined for clinical trial or commercial product: GMP-Source™ or cGMP. A faster, cost-effective alternative to cGMP production, GMP-Source can be manufactured to standard or customizable specifications. Driven by a comprehensive quality assurance process, we produce cGMP plasmid template in segregated ISO-classified manufacturing suites ensuring the highest quality products with each and every order.
Process Development and Scale-Up
Generating a small scale IVT experiment to understand construct attributes and process sensitivities. The IVT volumes between 15-50mL are directly scalable to cGMP full-scale processes.
pDNA Linearization
From milligram to multigram quantities, we provide linearized plasmid DNA using a variety of enzymes with advanced purification techniques. We evaluated a variety of resin and buffer combinations as well as post-linearization purification strategies, with the result being 90-95% recovery of linearized DNA with a consistently high poly(A) tail length.
During development, you must ensure the construct is designed with the proper restriction sites to produce a high-quality, non-truncated linear plasmid.
IVT Screening Optimization
Aldevron’s IVT Screening service helps researchers optimize mRNA production before cGMP manufacturing. In just two days, we test 26 conditions to improve purity, yield, and consistency—delivering full-length product up to 92%, reducing variability by 77%, and doubling yield. This scalable, data-driven process strengthens proof-of-concept and sets your program up for cGMP success.
Follow the path of success to the next Platform Phase: