One Shanghai facility. Single quality system.

Our manufacturing site is in the Shanghai metropolitan area, the city that hosts the largest concentration of pharmaceutical-API contract manufacturers in Asia and where most of the specialised peptide-synthesis talent and infrastructure are co-located. All product shipments originate from this single facility under a single quality system rather than being aggregated from multiple third-party suppliers.

Every step from incoming raw-material qualification through synthesis, purification, lyophilization, sterile vial fill, secondary packaging, batch release, and outbound cold-chain logistics is performed under one quality-management framework with one document-control system and one batch-traceability chain. No production step is outsourced to a third party. The practical consequence: if you receive a batch with an analytical anomaly, the audit trail back to the synthesis cycle, the operator, the raw-material lot, and the QC method is all in one document set, not stitched across multiple suppliers' systems.

Sterile vial-filling operations run under ISO 7/8 cleanroom conditions per ISO 14644-1, the standard cleanroom specification for aseptic pharmaceutical fill-finish operations in non-EU/US-FDA-regulated facilities. Particulate-count monitoring runs continuously during fill sessions; non-viable particles are tracked at the 0.5 µm and 5 µm thresholds, and viable particle counts are sampled per filling-session at fill-line, operator, and ambient positions. Cleanroom HEPA filters are integrity-tested per the standard schedule.

Yes. Established commercial buyers with appropriate confidentiality framework (mutual NDA) can request on-site facility audits, typical scope covers production-line walkthrough, QC laboratory access, document-system inspection, raw-material qualification review, and sample retention room access. Audit scheduling typically runs 4-6 weeks lead time because we coordinate the audit team's access against ongoing production schedules. 503B-pathway buyers and pharmaceutical CDMO partners are the most common audit requesters.

On-site analytical equipment covers the standard release-testing scope: reverse-phase HPLC (multiple instruments, with photodiode-array and ELS detectors for the broader compound classes), ESI mass spectrometry (LTQ Orbitrap for high-resolution identity confirmation and tandem-MS sequence verification), Karl Fischer titration for water content, gas chromatography for residual-solvent screening, and atomic absorption / ICP-MS for trace-metal and copper-content verification on the copper-peptide product line. Outsourced testing: USP <85> bacterial endotoxin (LAL) and USP <61>/<62> microbial limits run at an accredited third-party laboratory for added independence, with results consolidated into the batch COA before release.

Released-batch material is held at -20 °C in dedicated cold storage with continuous temperature monitoring and door-event logging. Outbound shipments use validated insulated packaging with the appropriate cold-chain configuration for the destination market: dry-ice for frozen-route shipments (typically 72-120 hours hold time), gel-pack with PCM (phase-change material) for refrigerated 2-8 °C routes (typically 48-72 hours), and ambient-tolerant packaging for lyophilized material where the destination regulatory framework permits ambient-shipping. Every shipment carries an electronic temperature data logger; the temperature record becomes part of the released-batch documentation chain.