At PolyPeptide Laboratories, quality processes and quality management are paramount at every step of development and production.
With regards to GMP manufacturing, robust and discriminatory analytical methods are developed at the start of each project and validated as the campaign proceeds. Rigorous analytical characterization at the start of a GMP project is essential for both the development of a robust manufacturing process and for ensuring the quality of the API.
Impurities, especially those that arise from the solid phase synthesis of larger peptides, can create problems down the line if not detected as early in the campaign as possible. Our strategy is to begin state-of-the-art testing at the start of each project to detect and avoid any impurities (including enantiomers) that could create costly problems and delays later.
