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.
Peptide Technology Platforms
- Solid/liquid phase preparation
- Chromatography separation
- Membrane concentration/purification
- Lyophilization and spray drying
- Flow chemistry and biotransformation platform for complex key materials production
From Peptide to Peptide Plus
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:
- Linear and cyclic peptide with up to 40 amino acid units
- Natural peptide modifications
- Linear/ cyclic polypeptide with disulfide bond
- Cyclic stapling peptide / thioether peptide
The served projects cover GLP-1, antiviral, antibacterial, antitumor, age-related macular degeneration and other treatment areas.
- SPPS, LPPS, and Hybrid Fragment strategy
- Peptide modification: PEG, lipidation, N-methylation, and etc.
- 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