How our material is made and controlled

Synthesis

Short and medium-length sequences are produced by Fmoc solid-phase peptide synthesis on automated synthesisers. The chain is assembled from the C-terminus, one protected residue at a time, with coupling completion monitored at each step so that deletion sequences are caught during assembly rather than at final analysis.

Sequences beyond the practical reach of stepwise synthesis are produced by recombinant expression and purified through orthogonal chromatography steps. Production route is recorded per lot and appears in the lot documentation.

Cleavage and purification

Crude peptide is cleaved from resin with scavenger cocktails selected for the side-chain protecting groups present, then purified by preparative reversed-phase HPLC on C18 stationary phase under an acetonitrile gradient.

Fractions are analysed individually and only those meeting the purity specification are pooled. Pooled material is lyophilized directly from the collected fractions after solvent reduction.

Environmental controls

Fill and finish operations are carried out in a classified cleanroom environment under unidirectional airflow, with continuous particle and differential-pressure monitoring and scheduled environmental surface testing.

• ISO Class 8 cleanroom with ISO Class 5 laminar flow at the fill point
• Continuous temperature, humidity and differential-pressure logging
• Gowning, material airlock and cleaning validation procedures
• Segregated handling to prevent cross-contamination between sequences

Fill, seal and packaging

Material is filled into USP Type I borosilicate vials, stoppered with washed and sterilised butyl rubber closures, and sealed with a crimped aluminium overseal. Headspace is displaced with inert gas before sealing to limit oxidation during storage.

Each vial is labelled with product name, strength, lot number, manufacture and retest dates, storage temperature and a QR code that resolves to the lot record. Labels are reconciled against the fill record before a lot is released.

Storage and dispatch

Released lots are held at -20 °C in monitored freezers with alarm callout. Lyophilized material is ambient-stable through normal transit windows, so orders ship in protective, discreet packaging at room temperature — refrigerate on arrival.

Documentation and traceability

Every lot carries a complete record from raw material through synthesis, purification, analysis, fill and release. Lot numbers printed on vials tie directly to that record and to the certificate of analysis supplied with the shipment.

Retained samples from each lot are held under storage conditions so that any question raised later can be answered against the original material rather than a reconstruction.