Pre-GMP development

We believe that investing the time in developing a robust production approach is essential to ensure the success of a product.  With over 1000 GMP peptides manufactured within the Group, PolyPeptide offers the knowhow to develop the most efficient protocols in designing a cost-effective production approach.

Furthermore, at PolyPeptide care is taken to develop the analytical characterization of any lead peptide designated for GMP manufacture as soon as the pre-development campaign starts.  The key is to develop the necessary methods to uncover any impurities that may not be initially visible, in order to avoid potential problems at a later stage.

The designed manufacturing scheme is then applied to the production of the initial pilot lots and pre-GMP animal toxicology lots.

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