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GMP peptides

1.GMP Peptides Synthesis technologyWith over ten years of technology and know-how, Scipeptide has established a synthesis technology  fit  for the characteristics of peptides and a specialized synthesis technology will be chosen depending on the construction and length of the amino-acids,scale,and most importantly,the client's requests.

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 Fmoc-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 SPPS.

2.Purification &Isolation

Using a high-capacity HPLC,based on a purification technology developed in Scipeptide,high-purity products capable of being used for medicine is manufactured, With a high-capacity freeze dryer,products ranging from gram to kilogram unit-batches can be produced Purification(liquid-phase chromatography)-Purification system:Column ID 15cm(DAC) Length 50cm-Packing Material:ODS C18,10um-Purification capacity:300-500g/day-All systems are validated Isoation(lyophilization)-100.000 class clean room and 100 class clean booth.-One classified isolation suite with lyophilization capacity up 50Kg(ice capacity);gram to multi-kilogram quantities of peptides for 1 batch.-SUS 316L 15 Tray with cover:connected with N2 purge system.-All systems are validated


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.
Our standard GMP specifications include



-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



-Other API

-specific parameters

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