Technical Processes¶
Official Process Documentation
For product inquiries or custom synthesis services, visit the SENO Biotechnology Official Website.
Manufacturing Processes¶
| Process | Document | Key Technologies |
|---|---|---|
| Peptide Synthesis | SPPS Solid-Phase Process | Fmoc/tBu SPPS |
| Purification | HPLC Purification Process | RP-HPLC, C18 |
| Lyophilization | Freeze-Drying Process | 3-stage freeze-drying |
| Counterion Exchange | TFA to Acetate/HCl Conversion | Ion exchange, lyophilization |
Analytical Methods¶
| Document | Covered Methods |
|---|---|
| QC Analytical Methods Overview | HPLC, ESI-MS, KF, GC, LAL, AAA |
| Mass Spectrometry Analysis | ESI-MS principle and interpretation |
| Method Development Guide | HPLC column selection, gradient optimization |
| Peptide Solubility Guide | Solvent selection, troubleshooting |
Quality and Validation¶
| Document | Scope |
|---|---|
| QC Workflow Overview | Raw material to final release |
| Equipment Qualification (IQ/OQ/PQ) | Installation, operation, performance qualification |
| Cleaning Validation Protocol | Residue limits, sampling, acceptance |
| Stability Study Protocol | ICH conditions, sampling schedule |
| Scale-Up Guide | 0.5 L to 20 L process transfer |
| Supplier Management | Supplier qualification and monitoring |
Support Documentation¶
| Document | Scope |
|---|---|
| Packaging and Labeling | Container types, labels, storage |