Details on Contract GMP Peptide Synthesis

Our aim is to provide our customers with peptides that match their requirements. Our unique capabilities in large-scale synthesis and purification enable us to provide pharmaceutical-grade peptides of exceptional quality in quantities ranging from milligrams to multiple kilograms. We cover the synthesis scale for early stage research projects as well as kg scale for GMP production.


Synthesis Scale

  • Automated, paralleled solid phase peptide synthesis in 50 µmol scale for research applications, method scouting and feasibility studies. Please have a look at our pricelist for custom peptide synthesis.
  • 2,5 mmol scale for mid scale production of non-GMP and GMP material
  • Computer-assisted synthesis equipment at kg-scale for solid phase GMP production of peptides.
  • Solution phase synthesis in reaction vessels up to 200 L for multi-kg peptide synthesis.


Modifications

  • Drug-peptide conjugates
  • Glycopeptides
  • Lipopeptides
  • Phosphopeptides
  • Cyclic peptides
  • Peptides with S-S bonds
  • Peptides with non-natural or unusual amino acids
  • Peptides, biotinylated
  • Peptides labeled with chromophores
  • Peptides, pegylated
  • Peptide aldehydes, - alkohols,
  • and other C-terminal modifications
  • Peptides labeled with C13 or N15


Downstream Processing

Whilst our normal target is minimum 97% HPLC peptide purity, which should be adequate for most biological and clinical applications, we can supply peptides of higher or lower purity. HPLC instrumentation covers the following range:

  • Analytical HPLC for purity conformance checks
  • Semi-prep HPLC yielding hundreds of milligrams
  • Prep HPLC columns up to industrial scale bed volumes


Documentation

Along with Certificates of Analysis for peptides, documentation of procedures and other data can be provided also for non-GMP products. Quality control documentations for all raw materials applied in the manufacturing process are available on request. Mid and large scale production is routinely performed with GMP qualified instrumentation in an appropriate environment. This way, we are tremendously simplifying the development of the GMP production processes while effectively keeping the work cost low and affordable.

All GMP-grade peptide production strictly follows GMP and ISO-9001 / 2000 guidelines. Please call upon us to discuss your individual requirements. We welcome the opportunity to put our technical and regulatory experiences into work for you.