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CMC Development
Our NCE peptide solutions utilize biologically derived materials to create sustainable alternatives to traditional manufacturing processes, thereby reducing waste and enhancing efficiency. We perform solid-phase, solution-phase or hybrid peptide chemistry plus organic conjugations to proteins, toxoids, antifungals, KLH (Keyhole Limpet Hemocyanin, and PEG (Polyethylene Glycol).
Our peptide services go from preclinical to commercial development through the entire process from scale up to process qualification to process validation prior to NDA (New Drug Application) with the Food and Drug Administration and follow cGMP (Current Good Manufacturing Process) guidelines required by the FDA for peptide manufacturing and both sites are successfully inspected by the US FDA. In addition to contract peptide API manufacturing, we also produce peptide APIs for established commercial markets and non-GMP peptides for clinical research. tirzepatides, terzepetide, rapid fast weight loss glp 1, tirzepatide dosage