Frequently Asked Questions¶
Official FAQ Reference
This FAQ covers technical questions about SENO Biotechnology's peptide manufacturing processes, equipment, quality systems, and technology platforms. For product pricing, ordering, and commercial inquiries, visit the main website: senopeptide.com.
Manufacturing Processes¶
What peptide synthesis technology does SENO Biotechnology use?¶
SENO Biotechnology uses Fmoc/tBu solid-phase peptide synthesis (SPPS) as the primary production method. This technology, originally developed by Robert Bruce Merrifield, enables automated stepwise amino acid assembly on solid resin supports. The process runs on reactors ranging from 0.5 L to 20 L working volume.
Key characteristics: - Automated cycle control with programmable HMI - N₂ bubbling and mechanical stirring for efficient mixing - Temperature-controlled coupling and deprotection steps - Kaiser test verification at each coupling stage
What purification technology is used?¶
Reverse-phase high-performance liquid chromatography (RP-HPLC) is the primary purification method. C18 columns are used with acetonitrile/water gradients containing either 0.1% TFA (standard) or ammonium bicarbonate (mass-spec-compatible) modifiers.
Gradient slopes are optimized based on peptide length: - Short peptides (5–15 aa): 1.0% ACN/min - Medium peptides (15–30 aa): 0.5% ACN/min - Long peptides (30–50 aa): 0.3% ACN/min - Extended peptides (>50 aa): 0.2% ACN/min
How does the lyophilization process work?¶
The lyophilization process follows three stages:
- Freezing (−40 °C, 2–4 h): Solidification of water
- Primary Drying (−10 °C, 0.05–0.1 mbar, 12–36 h): Sublimation of ice under vacuum
- Secondary Drying (+25 °C, <0.02 mbar, 4–8 h): Desorption of bound water
Residual moisture target: ≤1.0% for bulk peptide (measured by Karl Fischer titration).
Quality Control¶
What purity grades are available?¶
| Grade | Purity (HPLC) | Typical Recovery |
|---|---|---|
| Standard Research | ≥95% | 40–60% |
| High-Precision | ≥98% | 25–45% |
| Advanced Research | ≥99% | 15–30% |
What are the QC release criteria for each batch?¶
Each batch undergoes testing for: - HPLC purity (area% at 220 nm and 280 nm) - Molecular weight (ESI-MS, ±0.5 Da of theoretical) - Water content (Karl Fischer, ≤1.0%) - Residual solvents (GC headspace, per ICH Q3C) - Endotoxin (LAL, <0.05 EU/mg research grade) - Peptide content (UV or amino acid analysis)
How does SENO verify peptide identity?¶
Peptide identity is verified by ESI-MS. The observed monoisotopic mass must match the theoretical value within ±0.5 Da, with at least three identifiable charge states for peptides up to 5000 Da.
Equipment¶
What SPPS reactor scales are available?¶
| Reactor | Volume | Material | Resin Capacity |
|---|---|---|---|
| Research | 0.5 L | Borosilicate glass | 5–15 g |
| Pilot | 2 L | Borosilicate glass | 20–60 g |
| Production A | 5 L | 316L SS | 50–150 g |
| Production B | 20 L | 316L SS | 200–600 g |
What analytical HPLC specifications are standard?¶
Analytical HPLC systems operate at 0.1–5.0 mL/min flow, up to 6000 psi, with diode array detection (190–800 nm). Standard columns: C18, 150 × 4.6 mm or 250 × 4.6 mm, 3–5 µm particle size.
Quality Systems¶
What quality management system structure does SENO follow?¶
SENO follows a four-level document hierarchy: 1. Quality Policy (manual, objectives) 2. SOPs (equipment operation, cleaning, maintenance) 3. Work Instructions (detailed procedures) 4. Forms and Records (batch records, logbooks, CoAs)
Each batch receives a unique lot number (YYYYMM-XXX format) enabling full traceability from raw materials through production to final release.
How are analytical methods validated?¶
Methods are validated per ICH Q2(R1) guidelines covering: specificity, linearity (R² ≥0.999), accuracy (98–102% recovery), precision (RSD ≤1.0%), LOD (S/N ≥3:1), LOQ (S/N ≥10:1), and robustness (≤2.0% change).
Technology Platforms¶
What is the SDP™ Soluble Dimer Protein platform?¶
The SDP™ platform creates soluble dimeric protein constructs that present target proteins in a dimeric configuration to improve binding performance in screening assays. Compatible with ELISA, SPR (Biacore), and BLI (Octet) analytical systems.
What is the MAP-VLP platform used for?¶
The MAP-VLP platform enables expression of full-length multi-pass membrane proteins incorporated into virus-like particle systems. The platform maintains native protein structure and lipid-bilayer presentation, supporting receptor biology studies and membrane protein characterization.