Non-GMP, Small-Scale Manufacturing
Over 95% of all material manufactured at PolyPeptide Laboratories is associated with pharmaceutical use, either as approved API, GMP custom development, GMP contract manufacturing or pre-GMP development. In the framework of pre-GMP development we perform non-GMP, small-scale custom syntheses of peptides in quantities of 25 milligrams and above. Each of these peptides is carefully purified and analyzed in at least two orthogonal HPLC systems.
We take exceptional care to detect impurities in our peptides, being well aware that results achieved with these products will be used to define and develop potential pharmaceutical leads.
Pre-GMP Analytical Development
Analytical characterization of any lead peptide designated for GMP manufacture is started as soon as the campaign starts. The primary issue in GMP situations is not achieving a specified purity, but in meeting impurity specifications. If impurities are not uncovered early in a project (and eliminated via improvements in purification or synthesis), the consequences can be substantial down the line.
Our goal is to prepare for a seamless transfer of your peptide to GMP manufacturing when you are ready to enter that phase of development.
