GMP Service

Chemi Peptides offers the possibility to develop a tailored synthesis scheme since the early stage of a new peptide’s development, creating a robust and fully scalable process from the beginning to facilitate  each future development and scale-up.
The choice of having a robust and fully scalable process from the beginning is an essential point to facilitate each future development and scale-up.
Chemi Peptides has the capabilities to support all the regulatory aspects of the peptide development, starting from the clinical phases up to the drug product registration, in worldwide countries. (i.e. US, Eu , JP)

Chemi Peptides can produce both non-GMP batches, suitable for pre-clinical GLP studies, as well as full GMP material to be used in clinical trials. The batches intended for use in clinical studies are produced and analyzed in compliance with cGMP, according to the ICH guidelines.
Production processes can be performed for any peptide, whatever its complexity, achievable by solution synthesis.

Chemi Peptides offers its high level analytical skills for both the identification of critical impurities and for the deep characterization of the peptide quality.  Definition of the quality aspects since the early stages of the development.
It’s highly convenient to define the quality aspects already in the early stages of the development (i.e pre-clinical toxicology – phase I) in order to avoid any possible misleading result.

Chemi Peptides experienced regulatory staff will guarantee a full assistance in responding to any deficiency could possibly be reported from whatever national regulatory authority.

Chemi Peptides offers his lasting experience of organic chemistry to accommodate projects of chemically modified peptides and peptide mimetics.

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