Manufacturing Capabilities

Chemi Peptides has a long standing experience on solution phase peptide synthesis, both stepwise and by fragments condensation. You will thus benefit from the following advantages:

  • Early development of a synthetic (and purification) process that will be suitable during the entire scale up.
  • An impurities  profile that will be the same from the phase I up to the commercial batches.

DOWN STREAM PROCESS, the common bottleneck for all the manufacturing strategies.
Chemi Peptides has a long knowledge in the use of an original know-how for the purification of peptides:
High Performance Displacement Chromatography (HPDC).
This technique allows a very effective purification while lowers consumption of stationary phase and solvents.

The maximum batch size of a peptide depends on its chemical features.
Chemi Peptides has the capability to manage any kind of medium sized peptide (up to 40 residues) producing early phases batches, as small as tens of gram up to commercial batches of hundreds of kilo.

The production process and the analytical methods will be qualified and/or validated according to the needs of the relevant clinical phase or of the dossier for the Marketing Authorization.
The Quality Assurance departments of Chemi Peptides and Chemi SpA have a long experience in PROCESS VALIDATION, that regularly conducing to:

  • Support multicenter clinical trials.
  • Allow the filing of dossiers at several international regulatory authorities.