Complete Solutions for mRNA Drug Development and Large-Scale Manufacturing
As an established manufacturer of plasmid DNA templates for mRNA synthesis by in vitro transcription, Aldevron has responded by expanding our offerings to include enzymes for mRNA synthesis in a range of configurations from Research Grade to GMP drug substance and product to support research through clinical stages of development. The ability to offer such a range of specialized products and services for mRNA production provides several benefits including reduced supply-chain risks, shorter lead times and increased quality. The production of mRNA by Aldevron can begin with an electronic DNA template sequence or supercoiled plasmid DNA provided by the client, and options are offered for capping, tailing and chemical modification to satisfy a wide range of application requirements.
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
GMP Master Cell Bank generation
- Generate GMP cell bank that could be used for research and GMP projects
- Enable faster project execution during late state clinical phases
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.
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® (GMP-S) or cGMP. A faster, cost-effective alternative to cGMP production, GMP-S can be manufactured to standard or customizable specifications. Driven by a comprehensive quality assurance process, we produce GMP 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 which is a directly scalable to GMP full scale process.
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. The result was 90-95% recovery of linearized DNA with a consistently high poly(A) tail length.
During development, ensuring the construct is designed with the proper restriction sites, to ensure a high quality non truncated linear plasmid.
Follow the path of success to the next Platform Phase: