Commercial Capacity
Large-Scale Production of Peptide, Oligonucleotide, and Small Molecule NCEs
Capacity
Commercial-Scale Manufacturing Capacity
With an established expertise in the synthetic manufacturing of complex large molecules, including peptides and oligonucleotides, we provide customized, science-driven solutions to advance your biologic development from early-stage research to commercial-scale production.
GMP Manufacturing Equipment
Large-scale reactors enable peptide and oligonucleotide production at multi-kilogram to ton quantities in a single campaign, dramatically improving cost-efficiency and supply reliability compared to small-vessel synthesis. High-capacity reversed-phase chromatography columns, often combined with dynamic axial compression, deliver superior resolution and loading capacity, allowing high-purity isolation of full-length product while removing truncated or deletion sequences in fewer cycles. These systems maximize batch yield through optimized reaction conditions and loading strategies, reduce overall processing time with faster flow rates and shorter cycle times, and minimize risk by relying on proven, linear scale-up pathways that eliminate surprises during commercial transfer. The result is accelerated timelines, lower cost of goods, and consistent delivery of clinical and commercial material without costly re-optimization or delays.
Automated Synthesizers
| Capacity | # Reactors | Total (L) |
|---|---|---|
| 300 L | 2 | 600 |
| 500 L | 1 | 500 |
| 1000 L | 2 | 2,000 |
| 1200 L | 3 | 3,600 |
| 2000 L | 8 | 16,000 |
| 3000 L | 14 | 42,000 |
Dynamic axial compression (DAC) maintains uniform bed density throughout operation, delivering consistently high column efficiency, excellent peak symmetry, and long-term stability without the need for frequent repacking. It virtually eliminates channeling and voids even at large diameters, enabling reliable scale-up from grams to multi-ton production with predictable performance.
Purification Columns
| DAC Columns | Brand | # |
|---|---|---|
| DAC 200 mm | Novasep | 2 |
| DAC 300 mm | Novasep | 2 |
| DAC 450 mm | Novasep | 2 |
| DAC 590 mm | Novasep | 6 |
| DAC 1000 mm | Novasep | 3 |
| DAC 200 mm | Hanbon | 2 |
| DAC 300 mm | Hanbon | 8 |
| DAC 600 mm | Hanbon | 11 |
| DAC 1000 mm | Hanbon | 23 |
| DAC 1200 mm | Hanbon | 16 |
Lianyungang Site
GMP Peptides | Oligonucleotides | Small Molecules
Chemical Capacity (MT)
Total Site Area (acres)
Peptide Capacity (MT)
Employees at this Location
Modalities Manufactured
Peptide Manufacturing Capacity
Flexible Scale-Up: From milligrams to hundreds of kilograms, our modular manufacturing systems support your program at every stage—from discovery to commercialization.
- Peptide capacity (Q2): 6.16 tons
- Projected capacity (Q4): 20–30 tons
- Reactor sizes: 50–3000L
- DAC purification columns: Up to 1,200 mm diameter
- Spray dryer throughput: 32 kg/h (200+ kg per batch)
Zhejiang Jiande Site
Chemicals | Small Molecule APIs
Largest Reactors (L)
Number of Reactors (#)
Number of Employees
Total Site Area (acres)
Synthetic Workshops
Inspection History
Since 2014, Sinopep’s GMP manufacturing facilities have successfully passed four (4) inspections conducted by the U.S. FDA, demonstrating our strong commitment to global regulatory compliance and product quality. In addition to these FDA audits, Sinopep has also undergone inspections by the Korean MFDS and has successfully completed 20 regulatory audits conducted by the NMPA in China.
| Date | Inspected Product | Inspection Type | Result |
|---|---|---|---|
| Apr 2014 | Peptide API (Eptifibatide) | FDA CGMP | Pass |
| Apr 2016 | Peptide API (Eptifibatide, Lanreotide acetate) | FDA CGMP | Pass |
| Jan 2019 | Peptide API (Eptifibatide, Lanreotide acetate, Bivalirudin, Octreotide acetate) | FDA CGMP | Pass |
| Nov 2023 | Small Molecule & Peptide API | MFDS CGMP | Pass |
| Sep 2024 | Peptide API (Tirzepatide, Semaglutide, Liraglutide, Cetrorelix acetate, Eptifibatide, Octreotide acetate, Bivalirudin, Lanreotide acetate, Desmopressin Acetate) - Unannounced Inspection | FDA CGMP | Pass |
| July 2025 | Semaglutide & Liraglutide | ANVISA CGMP | Pass |
