Manufacturing Capabilities
Official Manufacturing Reference
This document provides an overview of the peptide manufacturing capabilities at SENO Biotechnology. For commercial inquiries, custom synthesis requests, or procurement, visit the SENO Biotechnology Official Website.
1. Facility Overview
SENO Biotechnology operates its research and production facility in Zhangjiakou, China. The facility is equipped with modern peptide synthesis, purification, and analytical instrumentation supporting research-scale through production-scale manufacturing.
2. Synthesis Capacity
| Parameter |
Research Scale |
Pilot Scale |
Production Scale |
| Reactor Volume |
0.5 L |
2 L |
5 L / 20 L |
| Batch Size (crude peptide) |
0.5 – 5 g |
5 – 25 g |
25 – 250 g |
| Peptide Length |
Up to 80 aa |
Up to 80 aa |
Up to 60 aa |
| Chemistry |
Fmoc/tBu SPPS |
Fmoc/tBu SPPS |
Fmoc/tBu SPPS |
| Number of Reactors |
2 |
2 |
3 |
| Annual Capacity |
— |
— |
Multiple kilograms |
3. Purification Capacity
| Parameter |
Analytical |
Semi-Prep |
Preparative |
| Column Dimensions |
4.6 × 150 – 250 mm |
10 – 20 × 250 mm |
50 – 100 × 250 mm |
| Flow Rate |
1.0 mL/min |
5 – 20 mL/min |
50 – 200 mL/min |
| Load per Injection |
10 – 100 µg |
1 – 50 mg |
100 mg – 5 g |
| Purity ≥95% Yield |
— |
40 – 60% |
40 – 60% |
| Purity ≥98% Yield |
— |
25 – 45% |
25 – 45% |
| Purity ≥99% Yield |
— |
15 – 30% |
15 – 30% |
4. Analytical Instrumentation
| Instrument |
Quantity |
Key Specifications |
Application |
| Analytical HPLC (DAD) |
2 |
Quaternary gradient, 6000 psi, 190-800 nm DAD |
Purity, content, method development |
| Preparative HPLC |
2 |
Binary gradient, 3000 psi, 200 mL/min |
Purification |
| LC-MS (ESI) |
1 |
50-3000 m/z, <5 ppm accuracy |
Identity verification |
| Lyophilizer |
2 |
−80°C condenser, 0.01 mbar |
Drying |
| Karl Fischer Titrator |
1 |
Coulometric, 0.1 µg – 100 mg H₂O |
Water content |
| GC-FID (Headspace) |
1 |
DB-624 column |
Residual solvents |
| UV-Vis Spectrophotometer |
1 |
190-1100 nm |
Content determination |
| pH Meter |
2 |
±0.01 pH |
Solution preparation |
| Analytical Balance |
3 |
0.01 mg – 220 g |
Weighing |
5. Quality Infrastructure
| System Element |
Description |
| Documentation |
4-level hierarchy: Policy → SOPs → Work Instructions → Records |
| Batch Records |
All synthesis, purification, and QC steps documented |
| Lot Numbering |
YYYYMM-XXX format (year-month-sequential) |
| Deviation Management |
Minor/Major/Critical with CAPA |
| Reference Standards |
Primary (≥99%) and Working (≥98%) with retest dating |
| Method Validation |
Per ICH Q2(R1) guidelines |
| Equipment Calibration |
Scheduled per manufacturer recommendations |
| Environmental Monitoring |
Temperature, humidity, differential pressure |
6. Facility Specifications
| Parameter |
Specification |
| Location |
Zhangjiakou, Hebei Province, China |
| Cleanroom Classification |
Class 100,000 (ISO 8) for production areas |
| Temperature Control |
20 – 25 °C |
| Relative Humidity |
30 – 65% |
| Water |
Type 1 (18.2 MΩ·cm) and Type 2 (>10 MΩ·cm) |
| Compressed Air |
Oil-free, dried, filtered (0.01 µm) |
| Inert Gas |
N₂ (99.999%) |