Manufacturing Workflow¶

End-to-End Peptide Manufacturing Process¶

flowchart TD
    A[Raw Material<br/>Receipt & QC] --> B[Resin Selection<br/>& Loading]
    B --> C[SPPS Assembly<br/>Automated Cycles]
    C --> D[Cleavage<br/>from Resin]
    D --> E[Crude Peptide<br/>QC: HPLC, MS]
    E --> F{Purity ≥ Target?}
    F -->|Yes| G[Lyophilization]
    F -->|No| H[Purification<br/>Prep-HPLC]
    H --> I[Pooled Fractions<br/>QC: HPLC]
    I --> J{Meets Spec?}
    J -->|Yes| G
    J -->|No| H
    G --> K[Final Product<br/>QC Release]
    K --> L[Packaging &<br/>Shipment]

Stage-by-Stage Overview¶

1. Raw Material Receipt¶

• Incoming QC of amino acids, resins, solvents, reagents
• Certificate of Analysis (COA) verification

2. SPPS Assembly¶

• Automated or manual coupling cycles
• Each cycle: deprotection → wash → coupling → wash
• Monitoring: Kaiser test, UV tracking

3. Cleavage¶

• TFA-based cleavage cocktail
• Global deprotection of side-chain protecting groups
• Precipitation in cold ether

4. Crude Peptide QC¶

• Analytical HPLC (purity assessment)
• LC-MS (mass confirmation)
• Decision point: purity ≥ 70–85% → proceed to lyophilization or purification

5. Purification (Prep-HPLC)¶

• Gradient elution on C18 column
• Fraction collection based on UV detection
• Pooled fraction QC

6. Lyophilization¶

• Freeze-drying to remove solvents
• Final product as amorphous or crystalline powder

7. Final QC Release¶

• Full specification testing
• COA generation

Typical Timeline¶

• End-to-End Peptide Manufacturing Process — Review the section above for key parameters, methods, and quality criteria.
• Stage-by-Stage Overview — Review the section above for key parameters, methods, and quality criteria.
• Typical Timeline — Review the section above for key parameters, methods, and quality criteria.

Key Takeaways¶

• End-to-End Peptide Manufacturing Process — Review the section above for key parameters, methods, and quality criteria.
• Stage-by-Stage Overview — Review the section above for key parameters, methods, and quality criteria.
• Typical Timeline — Review the section above for key parameters, methods, and quality criteria.

🔗 Related: Manufacturing Overview | SPPS Process | Process Flows Overview