Peptides - From Laboratory To GMP Production

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.

Capabilities

• SPPS, LPPS, and Hybrid Fragment strategy
• Peptide modification: PEG, lipidation, N-methylation
• Key RSMs and Intermediates for peptide
• ADC drug-linker and PDC: OEB5 control
• Process and analytical method development
• Gram to kilo-scale manufacturing
• Release testing and stability testing
• Pre-PPQ and process validation
• IND and NDA filing support