What's on the label is the measured result — net peptide mass, not gross powder weight, plus RP-HPLC purity, on a lot-numbered COA for every batch.
Net peptide mass and RP-HPLC purity — a lot-numbered COA for every batch.
Net peptide mass + HPLC purity, per lot.
PCAC will review 7 peptides for the 503A bulks list, BPC-157, KPV, TB-500, MOTS-c, Emideltide, Semax, Epitalon. Read our briefing →
PCAC will review 7 peptides for the 503A bulks list. Read →
FDA PCAC reviews 7 peptides in July. Read →
Manufacturing Facility
Synthesis, purification, lyophilization, sterile vial fill, analytical release testing, and cold-chain dispatch, all under one roof and one quality-management framework. No outsourced production steps. Every batch is traceable to a single document-control system from incoming raw material through outbound shipment.
See the line
The video below was captured on-site during an actual production day. Same line every order ships from. No stock footage, no staged-photography compositing.
ISO 7/8 vial-filling line · 30s walk-through
Captured on-site during a production day in Shanghai.
Production process
Each stage has documented in-process controls and a downstream-quality gate. Failed controls trigger investigation and rework before the batch advances; nothing skips forward on assumption.
01
Every incoming Fmoc-protected amino acid, coupling reagent, and process solvent is qualified against pharmacopeia specifications before release to the synthesis floor. Per-lot identity, purity, and water content are confirmed at receipt; out-of-spec material is quarantined and returned to the supplier with non-conformance documentation.
02
Fmoc-strategy SPPS on multiple parallel reactor lines, scale-graded from research-batch (10-100 g) through pilot (1-10 kg) to commercial production. Synthesis cycle yield is monitored at every coupling-deprotection iteration; failed-coupling cycles trigger re-coupling before the next residue addition.
03
TFA-based cleavage from the resin under controlled-temperature conditions appropriate to the side-chain protection scheme. Crude peptide is precipitated into cold ether, washed, and held under nitrogen prior to purification. The crude-cleavage step is a critical-quality checkpoint for peptides with oxidation-sensitive residues.
04
Preparative RP-HPLC at column scales from analytical (4.6 mm internal diameter) through semi-preparative (50 mm) to production (300+ mm). Purification cycles target ≥99.0% area-purity on the analytical re-injection. Closely-eluting truncation and deletion impurities are cut against measured chromatographic resolution rather than blind retention-window assumption.
05
TFA-salt material from purification is exchanged to the target counter-ion (acetate by default) by either repeated lyophilization from dilute acetate buffer or ion-exchange chromatography. Counter-ion content is quantified on the released batch, acetate-salt material typically reports 4-12% counter-ion by mass.
06
Freeze-drying under vacuum with controlled shelf-temperature ramp and ice-condenser tracking. Lyophilization cycle parameters are optimized per peptide class, short hydrophilic peptides versus longer lipidated peptides versus copper-coordinated peptides each have different optimal cycles. Residual moisture is measured post-lyophilization by Karl Fischer.
07
Sterile-filtration through 0.22 µm filters into sterile holding tank, followed by aliquot fill into pre-sterilized vials under ISO 7/8 cleanroom conditions. Vial-fill weight is verified gravimetrically per-vial during the session; container-closure integrity (CCI) is tested on a sampling basis per the release protocol.
08
Released-batch QC covers HPLC purity (target ≥99.0% area), ESI mass spec confirming molecular weight within 0.5 Da of theoretical, water content by Karl Fischer, counter-ion content, and (for >15-residue peptides) LC-MS/MS sequence verification. Add-on tests on request: LAL endotoxin per USP <85>, microbial limits per USP <61>/<62>, stability data on the specific lot.
09
Outbound shipment uses validated insulated packaging with continuous temperature monitoring throughout transit. Frozen-route shipments use dry-ice with 72-120 hours hold time; refrigerated-route shipments use PCM gel-pack with 48-72 hours hold. Every shipment carries an electronic temperature data logger that becomes part of the released-batch documentation chain at receipt.
Capabilities at a glance
Audit & inspection
Established commercial buyers, 503B outsourcing facilities, pharmaceutical CDMO partners, large compounding-pharmacy networks, and downstream finished-product brand owners, can request on-site facility audits as part of supplier qualification. Typical audit 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. Mutual NDA is signed before document-system access; specific commercial-information protection scope is negotiated per audit. Travel coordination, on-site logistics, and post-audit documentation are handled by our quality team.
Frequently asked
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.
A first reply within 24 hours · Catalog · Sample COA · MOQ · Lead time. Our regulatory and sales teams read every inquiry before any price goes out.
