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GMP Peptides

PEPTIDES

GMP Peptides

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  3. GMP Peptides
  4. Manufacturing
Wide range from R & D to commercialization
01. Synthesis Technology

Based on our accumulated technology and know-how for over ten years, ANYGEN has established various synthesis methods for peptide characteristics, and the composition and length of amino acid, scale, and the synthesis method that is characterized by customer's request are selected.

  • Solid-Phase Peptide Synthesis(SPPS)

    The technology of choice for manufacturing most peptides up to multi-kg quantities, especially those with longer, more complex sequences. We offer F moc-based solid-phase manufacturing.

  • Solution Phase Peptide Synthesis(SPS)

    The technology of choice for manufacturing short peptides or structures that are inappropriate for a resin matrix. This approach ultimately provides a cost-effective process for large-scale manufacture of multi-g to multi-kg lots.

  • Convergent Fragment Synthesis (SPPS + SPS)

    This technology, which involves coupling shorter, SPPS generated sequences together in solution, is particularly suitable for some longer peptide structures. Offering higher yields than << Straight-through >> SPPS

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02. Purification & Isolation

Based on its own developed mass purification technology, it produces high purity products that can be used as raw materials for pharmaceuticals by using industrial HPLC and can be produced in one batch from g scale to kg scale using industrial freeze dryer.

  • Purification
    • 100,000 class clean room and 100 class clean booth
    • Purification system : Column ID 8cm to 20cm Length 50cm
    • Packing Material : ODS C18, 10μm
    • Purification Capacity : 350 ~ 500g/day
    • All systems are validated
  • Isolation (Lyophilization)
    • 100,000 class clean room and 100c class clean booth.
    • One classified isolation suite with lyophilization capacity up to 50kg (ice capacity); gram to multi-kilogram quantities of peptides for 1 bath
    • SUS 316L 15 Tray with over : connected with N2 purge system.
    • All systems are validated.
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03. QA/QC

To create the highest quality products through GMP validation, every manufacturing process is monitored, from raw material to synthesis, purification, drying, and before product release, they are inspected on numerous qualifications to ensure the also the safest product.

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  • Our standard GMP specifications include
    • Appearance
    • Solubility
    • Identity(via mass spectral analysis, amino acid analysis and HPLC)
    • Peptide purity (HPLC)
    • Related substances (HPLC)
    • Assay (as mass balance)
    • Counterion Content
    • Moisture content
    • Peptide content (by N%)
    • Trifluoroacetic acid content
    • Chloride content
    • Residual organic solvents
    • Bioburden
    • Endotoxin
    • Other API-specific parameters
research peptide drugs manufacturer Analysis Equipment MALDI-TOF Mass, FT-IR, UV/VIS, Polarimeter, Karl Fischer, HPLC, GC, TOC, Elisa Reader, BSC etc.
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