Raw materials for nucleic acid therapeutics
Four stages. One supplier. No requalification.
The cap analog you validate at 1 mL is the cap analog with a DMF at FDA when your program reaches clinical supply.
Where is your programme?
The chemistry is the same in all four stages. Only the paperwork and the volume change.
ISO 9001
Quality system supporting cGMP manufacturing.
DMF at FDA
Filed for GMP cap analogs and N1-Me-pUTP.
License free
Own chemistry, no royalty stacking.
RUO and GMP grade across the whole catalog
486 catalog items available online
Changing supplier is cheap early and brutal late.
Most upstream sourcing decisions get made at the bench, by someone optimising for this week. The cost of that decision arrives two years later, in a different department.
Research grade that has no GMP counterpart
Material that performs well in a research lot often cannot be reordered at GMP grade from the same vendor, forcing a new supplier qualification exactly when a programme is trying to move into IND enabling work.
A bridging study nobody planned for
Switching the source of a cap analog or a modified nucleotide mid-programme means demonstrating the change did not affect the product. That is time and material spent proving something you already knew.
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.
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.
Stage 01 — Screening constructs, not yet committed.
You are testing whether the construct works at all. Speed matters more than paperwork, and nothing should be waiting on a purchase order.
What we do here. Everything at this stage ships from Maryland stock, so a screen can start this week.
Stage 02 — Locking the process before change gets expensive.
Yield, impurity profile and reproducibility become the questions. What you choose here is what your CMC section will describe later.
What we do here. Same catalog, larger sizes. Every item on this list also exists in GMP grade, which is the point.
Stage 03 — The first point where documentation decides the timeline.
Your quality team now needs a Drug Master File reference, batch records and a supply commitment. The chemistry does not change here. The paperwork does.
Why this stage is quoted. Cost depends on batch size and documentation scope, so a list price would be a guess. A signed quotation comes back within one business day.
Stage 04 — Scheduled releases against one agreement.
Supply continuity, audit readiness and lead time become the whole conversation. You are not buying a product any more, you are buying a commitment.
What we do here. Kilogram GMP campaigns under a framework agreement, with lead time confirmed before you commit and audit support when your quality team asks for it.
How this stage works
| Catalog # | Product / Service | Specifications / Deliverables |
|---|---|---|
| GMP bulk | Kilogram scale campaigns Service | Cap analogs and modified nucleotides — quoted per campaign. |
| Framework | Scheduled release agreement Service | Fixed pricing against forecast volume — negotiated. |
| Audit | Quality audit support Service | ISO 9001 system, documentation review — on request. |
| DMF-LOA | DMF Letter of Authorization Service | So your regulatory team can reference the filing — included with the quote. |
The chemistry does not change between these four blocks. That is the whole point.
Two of them carry an online price and two of them are quoted. That is a difference in documentation and volume, not a difference in material or in supplier.
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.
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
Chemists first, then a company
In 2018, a group of nucleic acid chemists ran into the same wall every mRNA lab eventually hits: the raw materials that make an mRNA programme possible — cap analogs, modified nucleotides, clean enzyme — were expensive, slow to get, and controlled by a short list of suppliers. Instead of licensing someone else's chemistry, they built their own.
That company, Synthgene Biotechnology, now runs its own cGMP manufacturing with more than 200 scientists in R&D. Areterna is the part of that company built for US and European labs: US contracting, Maryland stock, and a Drug Master File already on record with the FDA for our GMP cap analogs. We did not start as a distributor looking for a product line. We started as chemists looking for a way around a bottleneck.
| One cart, two ways to close it out | Buy now | Request a quotation |
|---|---|---|
| Which stages | Stages one and two check out with a card. | Stages three and four become a quotation. Same basket either way. |
| Pay with | Card, ACH or an approved net 30 purchase order. | A signed, dated PDF within one business day. |
| What follows | The confirmation carries the Certificate of Analysis and safety data sheet automatically. | Approving it online turns the quotation directly into an order, with the price locked to that document. |
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.
We are at stage two today. What actually changes when we reach stage three?
The molecule and the manufacturer stay the same. What changes is the documentation set, the batch size and how the material is priced. GMP grade adds a batch record, a lot specific Certificate of Analysis and a DMF Letter of Authorization your regulatory team can reference.
That is the reason stages three and four are quoted rather than listed: the scope of documentation and the batch size drive the cost, and a list price would be a guess.
Do we need a bridging study when we move from RUO to your GMP grade?
The chemistry is identical, which is the whole reason to stay on one supplier through the transition. Whether your specific programme needs a bridging study is a decision for your regulatory team and depends on your filing strategy.
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.
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.
| Documents by stage | What ships with the material | What your quality team can request |
|---|---|---|
| Discovery | Technical data sheet, safety data sheet | Nothing further is normally needed at this stage |
| Process development | Lot specific Certificate of Analysis | Impurity data |
| IND enabling | Batch record, lot specific Certificate of Analysis | DMF Letter of Authorization |
| Clinical supply | Supply agreement, scheduled release plan | Audit package |
Request a quotation
Tell us the target, the scale and the timeline you need. A scientist replies with pricing and a recommended route.