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 sys

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#ReactorsTotal (L)
300L2600
500L1500
1000L22,000
1200L33,600
2000L816,000
3000L1442,000

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 ColumnsBrand#
DAC 200 mmNovasep2
DAC 300 mmNovasep2
DAC 450 mmNovasep2
DAC 590 mmNovasep6
DAC 1000 mmNovasep3
DAC 200 mmHanbon2
DAC 300 mmHanbon8
DAC 600 mmHanbon11
DAC 1000 mmHanbon23
DAC 1200 mmHanbon16

Lianyungang Site

GMP Peptides | Oligonucleotides | Small Molecules

1000+
Chemical Capacity (MT)
59.8
Total Site Area (acres)
7+
Peptide Capacity (MT)
1200+
Employees at this Location
3
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

10,000
Largest Reactors (L)
432
Number of Reactors (#)
650+
Number of Employees
24
Total Site Area (acres)
12
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 FDA CCMP Pass
Apr 2016 Peptide API FDA CCMP Pass
Jan 2019 Routine Inspection FDA CCMP Pass
Nov 2023 Small Molecule & Peptide API MFDS CCMP Pass
Sep 2024 Routine Inspection (Unannounced Inspection) FDA CGMP Pass
July 2025 Semaglutide & Liraglutide ANVISA CGMP Pass