Commercial API supply
Commercial supply services for (non-generic) peptides
As the final step in our peptide pipeline services, we offer the commercial supply of NCEs or other custom peptides. Pepscan employs some of the industry’s finest chemists, who bring substantial expertise in the areas of peptide synthesis, upscaling and analysis.
Pepscan has a solid-phase production line at an FDA/ Swissmedic-inspected facility in Switzerland, with a batch capacity of up to 5 kilograms (depending on peptide characteristics/yield). We can also apply a hybrid approach for modifications in liquid as part of the synthesis process.
Our full range of QC methods is also available for commercial supply, including:
- Identity (ESI-MS)
- Purity, assay and impurities (HPLC/UV)
- Amino acid sequence (HR_MS-MS sequencing)
- Amino acid analysis (composition)
Net peptide content (GC or elemental analysis)- Enantiomeric purity (GC/MS; LC)
- Main counterion (IC or GC)
- Residual solvents (GC)
- Water content (GC or KF)
- Endotoxin
- Bioburden (TAMC/TYMC)
- Assay determination (potentiometric)
- TLC
- Optical rotation
- Other pharmacopeia compendial testing (RoI, LoD, identity, limit tests, etc.)
Our dedicated and multidisciplinary project team guarantees a smooth tech transfer from our facility in Lelystad, the Netherlands to our commercial production line in Switzerland, thanks in part to the similarities between the two.
