/ Manufacturing

From synthesis floor to sealed vial.

The protocol

Solid-phase peptide synthesis happens in a domestic GMP-aligned facility. Crude product is purified via reverse-phase HPLC against a strict ≥99% purity threshold. Every lot is then sent to a fully independent analytical lab — never one we own — for orthogonal verification.

Only after the third-party report clears do we lyophilize, fill, stopper, and lot-stamp the vials. The COA is published the same day the lot becomes available.

RP-HPLC
Reverse-phase chromatography against reference standard
LC-MS
Liquid chromatography mass spectrometry confirmation
Endotoxin
LAL kinetic chromogenic assay
Residual Solvent
GC headspace analysis per ICH Q3C
Bioburden
Aerobic microbial enumeration
Moisture
Karl Fischer coulometric titration