At PolyPeptide we provide our customers with expert knowledge for the manufacturing of peptide- and oligonucleotide-based API’s across the entire value chain from pre-clinical research to commercialization. We manufacture in non-GMP and GMP-quality and provide sophisticated process- and analytical development services as well as regulatory support.
API – Active Pharmaceutical Ingredient; CMC – Chemistry, Manufacuring & Controls; GMP – Good Manufacturing Practice; ICH – International Council for Harmonization; LCM – Life Cycle Management; NDA – New Drug Application; PPQ – Process Performance Qualification.