Raw Materials for mRNA Therapeutic Manufacturing
In recent years, in vitro transcription has rapidly become a key component of the mRNA therapeutic manufacturing workflow. To ensure the safety and effectiveness of the final therapeutic products, it is critical that the in-process raw materials for synthetic mRNA manufacturing meet the required quality requirements, perform consistently, and can scale up easily for commercial production.
Whatever your application, from vaccines to protein replacement to immunotherapies, we have cGMP and fit-for-purpose raw materials to support every phase of your mRNA therapeutic development.
cGMP Reagents for mRNA Manufacturing
Trusted Technology, Modern Modalities
For over 40 years, we have been a leading provider of in vitro transcription reagents supporting a variety of applications.
To better serve and support the needs of our customers in the rapidly growing arena of mRNA therapeutic development, we have upgraded the manufacturing and quality attributes of our trusted raw material reagents to ensure they meet the strict quality requirements for the manufacture of mRNA therapeutics.
Primary Manufacturer
As a primary manufacturer, we control all aspects of product manufacturing, from raw materials through finished product. With integrated logistics support and multiple global inventory locations, we effectively eliminate uncertainty to ensure consistent supply.
Fit-for-Purpose and cGMP Reagents to Take You From Template to Transcript
Template Plasmid DNA DNA Plasmid mRNA Synthesis
Design and Creation Amplification,
Purification and
Linearization
mRNA Purification mRNA Analytics Formulation, Fill and
Finish
cGMP: More Than a Marketing Term
cGMP-manufactured in vitro transcription reagents are supported by a comprehensive quality system and manufactured according to relevant ICH Q7 GMP principles.
Crunched for Time?
Download this flyer to learn more about our cGMP and fit-for-purpose raw materials for mRNA synthesis at your leisure.
Same Manufacturing Quality, Additional Testing If and When You Need It
As you make the transition from research into the clinical phases of development, you can easily upgrade to our cGMP products to get the testing and documentation required to support your quality needs.Animal Origin-Free Production – Animal origin-free manufacturing processes and raw materials.
Contamination Testing – Reduces the risks associated with contaminants that can potentially impact yield and quality of in vitro transcribed product.
Quality Documentation – Certificate of Analysis, Certificate of Origin and TSE/BSE Statements available upon request.
cGMP-Manufactured In Vitro Transcription Reagent Specifications
| T7 RNA Polymerase and 5X Reaction Buffer |
RNasin® Plus Ribonuclease Inhibitor |
Ribonucleotides | |
|---|---|---|---|
| Concentrations |
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[High] 500 U/µl |
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| Functional Tested |
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| Purity |
Base Purity ≥ 99.5% |
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| Undetectable |
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| Bioburden | |||
| Endotoxin | |||
| Host Cell DNA |
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| pH |
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| Documentation |
AOF/TSE/BSE Statement |
AOF/TSE/BSE Statement |
AOF/TSE/BSE Statement |
| cGMP for RNA Therapeutics |
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| Research Use Version |
Wherever You Are in the Process, We Can Meet You There
Our raw materials for mRNA synthesis offerings bridge the gap between early discovery and commercialization, allowing us to not only meet you where you are in the research phase, but to also easily grow with you as your manufacturing needs expand and change.
We offer custom formulations, formats and scale for both research-use and cGMP-grade reagents to deliver exactly what you need.
Early Discovery Research
We have both catalog and custom solutions to best fit your research-use only (RUO) mRNA therapeutic applications.
Looking For An Off-the-Shelf mRNA RUO Product?
Need a specific catalog enzyme, kit or assay? Explore our expansive portfolio of research-use solutions for RNA therapeutic discovery, characterization and analysis.
Need a Custom Research-Use Option?
Working to develop a unique therapeutic modality or looking to start scaling up but not sure where to start? Our scientists can work with you to help determine the best configuration of our technologies to meet your specific needs.
Large Scale Manufacturing
Our raw materials for mRNA therapeutic manufacturing can be customized and scaled to your unique production needs.
Looking to Scale Up or Need a Custom cGMP Solution?
From volume adjustments to unique kit configurations or formulation changes, we will collaborate with you to find the best solution to fit your specific needs.
Whether you need a few micrograms or a few kilograms, we can manufacture your desired quantities, without the hassle of changing vendors or products. With our facilities and technical expertise, we can seamlessly support an optimized pathway to large scale production of your product.
Small Enough to Listen, Big Enough to Deliver
mRNA therapeutics is a rapidly expanding area of drug development, with needs changing constantly. You need an innovative partner who is equipped to quickly pivot, optimize your process, and scale production as your manufacturing needs increase to help accelerate your time to market.
When you partner with us, you are getting more than scientific expertise—you are gaining the support of a collaborative, experienced team invested in your success.
