A 30,000 m² GMP-compliant campus engineered for pharmaceutical-grade peptide synthesis, purification, and lyophilization — delivering batch-to-batch consistency at commercial scale.
30,000 m²
Total Facility Area
Class A/B
Clean Room Grade
500 kg
Annual Capacity
40+
Export Countries
65+
QC Team Size
Our campus integrates synthesis, purification, lyophilization, and quality control under one roof — eliminating supply-chain fragmentation and ensuring full traceability from raw material to finished peptide.
30,000 m²
Total campus area across two production blocks and one R&D center
8 zones
ISO Class 5–8 cleanroom zones with cascading pressure differentials
12 lines
Independent SPPS & purification lines for parallel production
280+
Skilled scientists, engineers & QA specialists on site
2015
Established
ISO 9001 & 13485
Certified
24/7
Production Cycle
< 14 days
Avg. COA Turnaround
Every gram of peptide passes through five rigorously controlled stages. Our vertically integrated workflow eliminates third-party dependencies and ensures complete quality ownership.
Protected amino acids, resins & reagents sourced from qualified suppliers. Every lot identity-tested via HPLC-MS before release to production.
Solid-Phase Peptide Synthesis on automated synthesizers. Real-time coupling-efficiency monitoring ensures >99% stepwise yield from C to N terminus.
Multi-step preparative RP-HPLC achieving ≥98% purity on crude peptide. Method development tailored per sequence for optimal resolution.
Aseptic lyophilization under Class A laminar flow. Optimized freeze-dry cycles produce stable, low-moisture powder with ≥2-year shelf life.
Full-panel release testing: HPLC purity, MS identity, residual TFA, water content, endotoxin & sterility. COA issued with every batch.
Our analytical and production fleet is selected for industry-leading sensitivity, resolution, and reproducibility — every instrument is qualification-tested (IQ/OQ/PQ) on a scheduled cycle.
High-capacity gradient systems for multi-gram to kilogram purification runs. UV/Vis & ELSD dual detection.
Waters | AgilentUHPLC platforms with sub-2 µm columns for purity verification and stability-indicating assays.
Waters ACQUITY | ShimadzuHigh-resolution Q-TOF and triple-quad systems for MW confirmation, sequence verification & impurity profiling.
Thermo Fisher | AB SciexProduction-scale freeze dryers with shelf-temperature mapping and sterile venting for aseptic processing.
SP Scientific | ChristCoulometric KF systems for precise residual moisture determination down to ppm levels in lyophilized peptides.
Metrohm | Mettler ToledoKinetic chromogenic LAL testing with <0.005 EU/mL sensitivity. Batch release requirement for all injectable-grade peptides.
Charles River | LonzaAutomated microwave-assisted and room-temperature synthesizers with multi-channel capability. Real-time UV monitoring of Fmoc deprotection for coupling-efficiency tracking on every cycle.
Our quality management system (QMS) extends beyond the QC lab — it governs supplier qualification, environmental monitoring, personnel training, and deviation management. Every batch is released against a Certificate of Analysis reviewed by two independent QA officers.
Purity, identity, water content, TFA, endotoxin & sterility on every batch.
ICH Q1A-guided long-term, accelerated & stressed protocols per product.
21 CFR Part 11 compliant electronic batch records. Remote audit support available.
In-house characterized working standards cross-validated against USP/EP reference materials.
Certifications & Standards
We welcome prospective partners to tour our GMP facility, meet the QC team, and audit our systems firsthand. Virtual tours are also available for initial engagements.