From 10 grams to several hundred – A case study in peptide GMP process development

As a Contract Development & Manufacturing Organization (CDMO) of GMP-grade peptides, a central activity at PolyPeptide Laboratories is the development of robust and scalable manufacturing processes. Here, we present a case study describing the process development and the first GMP production of a 25-mer linear peptide which had only ever been previously manufactured in non-GMP batches up to 10 grams. We provide insight into a typical process development cycle and underline the key criteria which allowed for the definition of synthesis and purification conditions. Informed by results of our process development, we show how small adjustments applied to the GMP production campaign significantly improved both the yield and purity, enabling the isolation of several hundred grams of peptide API.