Asmychem’s Chemical Macromolecule Division (CMMD) can support traditional peptides, pseudopeptides , peptide+linker, peptide-drug conjugates, polymer-drug conjugates, and other highly active peptide molecules. Our analytical team can provide structure characterization, analytical method development, validation, IPC support, final product release testing, and stability study according to ICH requirement. In addition, our team can provide expert document preparation service to support IND /NDA filing. Utilizing QbD processes, analytical design and technical transfer via Scale Down Model (SDM) supports process validation and NDA filing.
With solid/liquid phase preparation and hybrid technology, Asymchem can provide development and manufacturing service ranging from pre-clinical to validation for NDA filing including:
The served projects cover GLP-1, antiviral, antibacterial, antitumor, age-related macular degeneration and other treatment areas.