Sourcing & intake
Every lot begins with raw API powder from a vetted manufacturer. We maintain a short list — currently five — of cGMP-certified suppliers, all of which we have audited on-site within the last 18 months. Audit reports are not public, but they are available to clinical partners under NDA on request.
When API arrives, the box is photographed sealed; the tamper seal is photographed; the COA from the manufacturer is filed against the lot number; and the box is opened only inside our intake clean area. If any of those four checks fail, the box is returned unopened. No exceptions, regardless of cost or schedule pressure.
Identity confirmation
The first thing that happens to incoming API — before it touches our purification line — is a mass-spec identity check. We pull a 5 mg sample, dissolve it in our standard mobile phase, and run it on the Q-Exactive Plus.
We're looking for two things: the parent ion at the expected m/z (within ±0.01 Da), and the absence of unexpected ions above 0.5% of the parent. The first confirms that we got the molecule we ordered. The second is our first look at the impurity profile and tells us whether the supplier's COA is honest.
Purification
If the API passes intake, it goes onto the prep HPLC. We use a C18 reverse-phase column with a water/acetonitrile gradient and 0.1% TFA as the ion pair. The exact gradient is peptide-specific and locked into our SOP per compound; deviation requires a CSO-signed change request.
Fractions come off the column and are collected against a UV trace at 220 nm. We cut conservatively: only fractions running ≥99.5% area-percent at the detector cut go into the pooled production lot. The rest — typically 12–28% of the load — are discarded or recycled into a development reserve.
Lyophilization
Pooled fractions are flash-frozen at -80 °C, transferred to lyo trays, and freeze-dried for 24–48 hours depending on the peptide and the load. Cycle parameters (shelf temp, condenser temp, vacuum) are recorded in the batch record.
Residual moisture is the gating spec out of lyo. We Karl-Fischer-titrate every lot and require ≤2.0% by mass; in practice we run 0.6–1.4%. Anything above 2.0% gets re-lyo'd or disqualified.
Aseptic fill
Lyophilized cake is reconstituted, 0.22 µm filtered, and aseptically dispensed into sterile glass vials inside an ISO Class 5 laminar flow hood. Particle counts in the hood are logged hourly; the analyst gowns in single-use sterile garments and stays inside the hood envelope for the full fill.
- Vial weight check at 1, 50, 100, and end of run — ±2% tolerance, every check logged.
- Stoppers and crimp seals are pre-sterilized; we do not autoclave on-line.
- The fill room is an ISO Class 7 background; the hood is Class 5 inside that.
Testing matrix
The eleven release tests, the methods we run them under, the spec, the typical observed value, and which lab in our rotation owns each one. Click any lot ID at the bottom to see a real signed COA in the viewer.
| # | Test | Method | Spec | Typical | Lab |
|---|---|---|---|---|---|
| 01 | Identity | LC-MS/MS, parent ion ±0.01 Da | Match | ±0.003 Da | Eurofins |
| 02 | Purity | UPLC, AUC at 220 nm | ≥99.0% | 99.4–99.7% | Eurofins |
| 03 | Related substances | UPLC, individual / total | ≤0.5% / ≤1.0% | 0.18% / 0.42% | Eurofins |
| 04 | Water content | Karl Fischer titration | ≤2.0% | 0.6–1.4% | Alcami |
| 05 | Endotoxin | Cartridge LAL (Endosafe) | ≤0.5 EU/mg | <0.10 EU/mg | Charles River |
| 06 | Bioburden — TAMC | USP <61>, plate count | ≤10 CFU/g | 0 CFU/g | Alcami |
| 07 | Bioburden — TYMC | USP <61>, plate count | ≤10 CFU/g | 0 CFU/g | Alcami |
| 08 | Sterility | USP <71>, direct inoculation | Pass | Pass | Alcami |
| 09 | Container closure integrity | Dye intrusion, vacuum | Pass | Pass | In-house |
| 10 | Sub-visible particulates | USP <788>, light obscuration | ≤6,000 / ≤600 (≥10/≥25 µm) | <500 / <40 | Eurofins |
| 11 | Net weight CV | Vial-to-vial gravimetric | ≤2.0% | 0.4–1.1% | In-house |
Release testing — process
Every release lot generates a sealed sample sent to one of three independent ISO-17025-accredited labs. Which lab gets which lot is rotated on a schedule we don't share with the lab — they cannot predict the lot ID coming. The testing panel covers:
- Identity — LC-MS/MS, parent ion confirmation
- Purity — UPLC, area-percent at 220 nm, ≥99.0%
- Related substances — UPLC, individual ≤0.5%, total ≤1.0%
- Water content — Karl Fischer, ≤2.0%
- Endotoxin — LAL, ≤0.5 EU/mg
- Bioburden — TAMC ≤10 CFU/g, TYMC ≤10 CFU/g
- Sterility — USP <71> on every fill lot
- Container closure integrity — dye intrusion, every lot
- pH — on reconstituted sample
- Particulate matter — sub-visible, USP <788>
- Net weight — vial-to-vial CV ≤2%
The COA returns to me. I sign every release personally. If anything is off — anything — the lot does not ship while I am still asking questions about it.
Stability program
For each peptide we maintain a real-time stability program at recommended storage conditions (typically 2–8 °C lyophilized) and an accelerated program (25 °C / 60% RH). We pull samples at 0, 30, 90, 180, and 365 days and re-run the analytical panel. Trends are published quarterly to clinical partners.
This is how we set our published shelf-life numbers. They are not extrapolated from a manufacturer's claim; they are observed in our cold storage with our lots.
When a lot fails
I'll be specific because most 'lab brief' pages on competitor sites are vague here. In the last 12 months, we have:
- Rejected 3 incoming API shipments at intake — 2 for tamper-seal issues, 1 for mass-spec mismatch.
- Discarded 4 production lots after purification — 3 for residual impurity above 0.5%, 1 for residual moisture above 2.0%.
- Held 2 lots at the COA stage for 14+ days while we re-tested anomalies. Both eventually released; one came back to me with an endotoxin result of 0.62 EU/mg (above our 0.5 spec). We re-filtered, re-tested, and only then released.
- Recalled 0 lots from customers.
If you are evaluating us against another supplier and you'd like to see the underlying batch records — within reason and with appropriate confidentiality — write to support. We have shown them to clinical partners; we will show them to you.