PeptisynthaProcess Development
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Process development

Each peptide sequence presents a specific challenge, especially when the objective is to set up a manufacturing process scaleable to multi-kilogram quantities in the most cost effective way.   The choice between different production methods is not only dictated by the detailed peptide sequence itself, but also by characteristics of the whole project (purity required, quantities required at different stages, development timelines …).  With our versatile peptide chemistries including Solution Phase and Solid Phase Peptide Synthesis, a wide range of possibilities can be screened before experimental work is started on process development.  

Considering all the project variables, the process development for a given peptide may be handled by SPPS or by solution phase chemistry, or may require both technologies (so-called hybrid production methods).   Accordingly, a project at Peptisyntha may include all or part of the following steps : synthesis of small quantities by SPPS, synthesis of a few hundreds of grams under cGMP conditions by SPPS, scale up to kilogram quantities in SPPS under cGMP conditions, design of a solution phase process through a lab scale feasibility study, successive scale up of the liquid phase process under cGMP conditions and eventually large scale cGMP production (up to 100+ kg per year) in a dedicated production suite. 

At each and every stage, we provide complete documentation and support in accordance with the requirements of the customer’s project status.  

      

[Non-GMP and cGMP production capabilities]   [Feasibility studies]   [Scale-up capabilities]   [Commercial scale production]  
 
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Date of last update: 1/5/2008