Business model

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.

Initial and clinical phases Commercial phase Drug product launch & commercialization Commercialsupply Product release& LCM Annual productreview Post approvalchanges Pre-clinicalresearch Customer drug discovery & lead optimization API manufacturing API process & analytical development Regulatory support & documentation Non-GMPbatches Process development Analytical method development Developmental stability studies and ICH stability CMC documentation and filing support Analytical method validation Process validation GMP clinical batches Scale-up batches PPQ batches Clinical development Phase I Phase II Phase III

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.