Synopsis
Take a tour through the five validation gates every BioEdge lot must clear before we release it to researchers.
Quality control is not a final checkbox at BioEdge Labs—it is the spine of every production sprint. Each lot travels through a defined series of validation gates that mirror pharmaceutical GMP expectations so researchers receive a peptide with a defensible chain of custody.
1. Raw material intake
- Supplier identity: We keep an approved vendor list with annual audits and traceable certificates.
- Incoming testing: ATR-FTIR and HPLC fingerprints confirm the stated amino acid sequence before the material moves forward.
2. In-process controls
During synthesis and purification we monitor solvent profiles, reaction yields, and column performance. Any drift from the control chart pauses the run for root-cause investigation.
- Peptide mapping via LC-MS at critical elongation steps.
- Moisture analysis before lyophilization to prevent cake collapse.
- Bioburden checkpoints that keep microbial counts at zero detectable CFU.
3. Finished product verification
| Attribute | Acceptance criteria |
|---|---|
| Purity | > 98% by HPLC |
| Identity | Exact mass confirmed by HRMS |
| Endotoxin | < 0.5 EU/mg per USP <85> |
4. Stability holds and documentation
Lots rest inside validated stability chambers while we generate accelerated and real-time data. We assemble the final dossier—batch record, chromatograms, COA, and telemetry report—before allowing the lot to be scheduled for pick and pack.
5. Release review
A second scientist, not involved in production, reviews the dossier for completeness. Only after dual signatures do we mint the digital Certificate of Analysis that customers can scan from the vial label.
What this means for researchers
Every shipment arrives with the evidence you need to defend your data: raw spectral files, temperature logs, and batch genealogy. Intellectual rigor is easier when your reagents arrive with the same transparency you apply to your own work.
