GMP raw materials for nucleic acid therapeutics
GMP raw materials for nucleic acid therapeutics
The cap analog already filed as a DMF at FDA. GMP grade nucleic acid chemistry for mRNA and oligo therapeutics, documented from bench to clinic.
The documentation package
Every GMP lot ships with the same set. None of this is assembled after a sale.
| Document | Scope | How you get it |
|---|---|---|
| Certificate of Analysis | Lot specific, not a product level document | |
| DMF Letter of Authorization | So your regulatory team can reference the filing | On request |
| Batch record | For GMP grade material | On request |
| Safety data sheet | Published on every product page | |
| ISO 9001 certificate | Quality system covering the manufacturing site | On request |
ISO 9001
Quality system covering NTP, modified NTP and cap analog manufacturing.
DMF at FDA
Filed for GMP grade cap analogs and N1-Me-pUTP.
License-free chemistry
Developed in house, no royalty stacking in the price.
Already in clinical trials
GMP material from this system is in active programs.
The upstream materials market was not built for how mRNA and oligo programs actually move.
Cap chemistry chosen by guesswork
There are more than a dozen cap analog structures, each with a different template start and linkage chemistry, and most technical sheets stop at the molecular formula.
dsRNA byproduct nobody budgeted for
Standard T7 in vitro transcription generates double stranded RNA byproduct that can trigger an innate immune response downstream, forcing extra purification steps late in the process.
A cliff between research grade and GMP grade
Material that performs well in a research lot often cannot simply be reordered at GMP grade from the same vendor, forcing a new supplier qualification right when a program is trying to move into IND enabling work.
Documentation that is not available on request
Auditors ask for a Drug Master File reference, a batch specific Certificate of Analysis and a credible supply commitment before a raw material goes into a filing.
Built as the upstream layer for that exact path, not a general reagent catalog.
01 Cap analogs organized by construct decision, not by catalog number
Cap analogs specified by template start, linkage chemistry and target application, turning cap selection into a lookup instead of a guess.
02 Impurity control planned into the process
Low dsRNA T7 polymerase paired with a dsRNA detection kit, so purification is a planned checkpoint instead of a late stage rescue.
03 The same chemistry filed and documented at GMP grade
Cap analogs and modified nucleotides used in clinical trials carry a Drug Master File already on file with the FDA, so material qualified in development stays available for clinical supply from the same manufacturer.
One supplier, from the first construct to the clinical batch.
Cap analogs and modified nucleotides exist in both research use and GMP grade, backed by Drug Master Files already on file with the FDA. The chemistry validated in a 1 mL research lot is the same chemistry available in a documented GMP lot once a program moves into IND enabling work. No new vendor qualification, no new bridging study.
How pricing works at each stage
| Catalog # | Product / Service | Specifications / Deliverables |
|---|---|---|
| Discovery | Priced online Service | Tool mRNA, research-size cap analogs and detection kits. |
| Process development | Priced, volume tiers Service | Low dsRNA T7, modified nucleotides at 100 mL scale, lipid screening. |
| IND enabling | Quoted per batch Service | GMP grade material with a DMF and a Letter of Authorization. |
| Clinical supply | Framework agreement Service | Kilogram GMP campaigns, scheduled releases, audit support. |
What is on file, not what is in a quote.
Areterna LLC was formed in 2023. Rather than ask you to take that on faith, here is what can be checked independently.
ISO 9001
Quality system covering NTP, modified NTP and cap analog manufacturing.
DMF at FDA
Filed for GMP grade cap analogs and N1-Me-pUTP, already used in active clinical trials.
Peer-reviewed use
Cited as reagents in independently published work in npj, Emerging Microbes and Infections, and Neural Regeneration Research.
R&D depth
Parent company Synthgene Biotechnology, founded 2018, roughly 400 people with over 200 in R&D and an AI assisted cap discovery platform.
Distribution
Running through BIORON in Germany, Bion2 in the Czech Republic and Medsol in Egypt.
CDMO partnership
Strategic partnership with Biomay, an Austrian mRNA CDMO, since September 2024.
Independently checkable, counted live
59 peer-reviewed publications citing our materials
24 technical documents available for download
The paperwork exists before you ask for it
A Drug Master File is already on file with the FDA for our GMP cap analogs. Those same materials are already inside active clinical trials. Our quality system is ISO 9001 certified, and it supports cGMP manufacturing, not just a marketing claim about it.
None of that happened because a sales team decided to write it into a brochure. It happened because Areterna's parent company, Synthgene Biotechnology, employs more chemists in R&D than most of its customers employ in an entire department, and has spent since 2018 building license-free chemistry instead of relying on someone else's patents. Areterna LLC is the US entity built to carry that supply chain into American and European labs, with its own stock, its own contracts, and its own accountability.
The catalog, counted from the product database
486 catalog items available online
| One cart, two ways to close it out | Buy now | Request a quotation |
|---|---|---|
| What it covers | In stock catalog items, where checkout works the way your card or accounts payable already expects. | GMP grade, kilogram campaigns and custom specifications, which do not carry an online price because cost depends on batch size and documentation scope. |
| Pay with | Card, ACH or approved net 30 purchase order | Any mix of catalog and GMP items on one request |
| You get | Tracking, CoA and safety data sheet on the confirmation | A signed, dated PDF within one business day |
| Suited to | Replenishing known catalog items | Process development, clinical supply, tenders |
Questions procurement asks before quality signs off
Your parent company is in China. Who am I actually contracting with?
Areterna LLC is the contracting entity, a US company and a wholly owned subsidiary of Synthgene Biotechnology. The split is straightforward: Synthgene manufactures the raw materials and holds the R&D team and the intellectual property. Areterna runs US distribution, lot release and customer service, and signs the supply contract with you directly.
Stock for both US and European customers is held in our Maryland warehouse and ships from there. There is no separate European warehouse, so EU orders leave the United States. Our products carry no country or end user restrictions under US export control.
If your quality team wants to see behind that structure, the site we can put in front of you is the Maryland facility, covering distribution, lot release and customer service. We would rather walk through that than have a procurement team guess at it.
Areterna was formed in 2023. Why should we qualify a supplier this new?
The US entity is new. The chemistry and the manufacturing are not. Synthgene has been building this since 2018, employs over 200 people in R&D, and the GMP material coming out of that system is already in active clinical trials with a Drug Master File on record at FDA.
What we do not have yet is twenty years of US commercial supply history, or a long list of publicly referenceable large scale supply agreements. If your program needs a fifteen year audit trail on file, we are not that supplier yet.
What is a DMF, and what documents can you actually provide?
A Drug Master File is a confidential submission to FDA describing manufacturing process, quality controls and facility information for a raw material, which a drug sponsor references in their own filing without receiving the full manufacturing detail. For GMP cap analogs and modified nucleotides, Areterna has filed a DMF and can issue a Letter of Authorization.
Your prices are lower than the suppliers we use today. What is the catch?
License-free chemistry developed in house removes royalty and third party synthesis markups from the cost structure. Grade, DMF filing and documentation stay the same regardless of price. We do not discount GMP material to win an order, and you will not find promotional pricing on the GMP lines.
Can we audit your facility before we commit to GMP volumes?
Yes, at our Maryland facility. That audit covers what Areterna operates directly: distribution, lot release and customer service. Manufacturing sits with Synthgene under an ISO 9001 quality system, and an audit of the manufacturing site is arranged separately.
Do you accept purchase orders and offer payment terms?
Approved purchase orders are accepted alongside card and ACH payment.
Certificate of Analysis, by lot
CoAs are lot specific. Enter the catalog and lot number to download immediately. If your lot is not in the system yet, it goes to a person on the quality team, and you hear back within one business day.
Both numbers are printed on the vial label and on the CoA shipped with your order.
Request this document
The quality team will email the certificate, usually within 1 business day.
Also available without a form
Request a quotation
Tell us the target, the scale and the timeline you need. A scientist replies with pricing and a recommended route.