The scale-up of a peptide manufacturing process up to the commercial scale production of kilogram quantities is the core expertise of Peptisyntha.  The first scale-up program is undertaken in kilolabs with the production of a few hundred grams (up to about one kilogram) of peptide.

Regarding process development, the production in our kilolabs is extensively documented and fully cGMP compliant.   The production in the kilolabs represents a very important step in the relation between Peptisyntha and the customers, whereby cGMP quantities of bulk peptide are produced to support the API needs throughout the clinical developments.    Considering the angle of process development, the production in the kilolabs provides the following output :

• confirmation and strengthening of the conclusions from the feasibility study
• characterization of intermediates and final bulk peptide obtained under conditions approaching commercial scale production
• understanding and resolution of potential process difficulties at scale
• availability of peptide quantities suitable for establishing robust analytical methods on intermediates and on the final peptide
• validation of the manufacturing process and of the analytical methods
• development of stability studies on the final bulk peptide. 

Finally, all the data generated during the scale-up studies are used at Peptisyntha to prepare and file a DMF (Drug Master File).