Where the API comes from. Where the vial goes after.
Seven hands. Every one signed.
From the moment a sealed drum leaves the API supplier to the moment your box scans at the porch, custody transfers seven times. Every transfer is signed, photographed, and logged.
API supplier
cGMP plant, audited. Drum sealed and serialized.
Bonded freight
Customs broker, temp logger inside. Tamper seal photographed.
Element MD intake bay
Seals verified, drum photographed, COA filed against lot.
LC-MS check
Mass-spec confirms parent ion. ±0.01 Da or quarantine.
Purify · lyo · fill
HPLC purification, lyophilization, ISO Class 5 fill.
3rd-party COA
Sealed sample to one of three ISO-17025 labs. CSO signs.
Cold-chain to you
Phase-change pack, GPS tracker, overnight from Boulder.
Five suppliers. Three we own audits on.
We don't blend manufacturers within a single lot. The supplier locked in for a given lot is printed on its COA. Below: who they are, what we audit them for, and when we last walked the floor.
Bachem-licensed partner · DE
cGMP · ISO 9001Polypeptide AG · CH
cGMP · DMF on fileCell Sciences Pharma · US-CA
cGMP · GMP-NWhat we actually check on-site.
Most "supplier audits" in our industry are paper exercises. Ours aren't. Here's what an Anya-led visit looks like — exact same protocol every time.
Walk the floor.
Two days minimum on-site. We watch a synthesis cycle from resin loading through cleavage. We do not accept "the unit is down today" — we'll come back when it's running.
Pull the batch records.
We pick the lot numbers, not the supplier. We trace from raw amino acid → resin → cleavage → purification → fill, against the documented SOP. Deviations get explained.
Inspect the deviations log.
A clean deviations log is a red flag. We want to see real failures handled correctly — out-of-spec results, equipment downtime, root-cause analysis. If they don't have one, they aren't running QC honestly.
Take a sealed sample home.
We pull our own sample from the line — sealed in front of us, signed by both sides, and shipped to our independent lab. The supplier's COA is irrelevant if our retest disagrees.
Read the environmental monitoring.
Hood particle counts, water-system bioburden, gowning logs. We've walked from suppliers whose Class 7 background room had no continuous particle monitoring at all.
Sign the audit report.
Every audit produces a 30+ page report with photos, observations, findings, and conditions for continued business. Findings have a 60-day remediation clock.
The 2 to 8 °C envelope, end to end.
Lyophilized peptide is robust at room temp for short transit, but reconstituted peptide isn't — and we ship lyo in cold for safety margin. Here's the envelope we hold.
Temperature envelope in transit
Validated phase-change packs hold 2–8 °C for up to 96 hours in 95th-percentile summer ambient. Every shipment has an internal temperature logger; if the log shows a breach, we replace the order at no charge.
How a vial actually leaves our dock.
Standard ground (2-day)
Insulated mailer, 2× phase-change packs, lot-keyed temperature logger. Cold-chain holds for 60+ hrs at 35 °C. Free above $99.
Overnight (priority)
Same insulated config, expedited carrier. Hand-off cutoff 2pm MT, in-transit by 4pm. Default for orders > $300, available on any order.
International (research)
For documented research institutions outside the US. Customs paperwork prepared by us; cold pack upgraded to 96-hour hold. Country-by-country eligibility.
Read the methods. Verify the vial.
The Lab Brief details every release test. The COA Lookup confirms any specific batch.