From laboratory to GMP production
As a strategic business unit, Asmychem's Chemical Macromolecule Division (CMMD) platform has over 100 experienced process and analysts (60% with PhDs or Masters), 1,000 ㎡ R&D laboratories, a 2,000 ㎡ GMP production facility equipped with multiple production lines and a 600 ㎡ high-potent GMP laboratory equipped with OEB5 level isolators.
After years of extensive development, Asymchem has established the peptide technology platforms such as solid/liquid phase preparation, chromatography separation, membrane concentration /purification, lyophilization and spray drying, and the complex key materials production by applying flow chemistry and biotransformation platform. In addition, QbD based process and analytical design as well as technical transfer via Scale Down Model (SDM) enables the process validation and NDA filing. Until now, we have established stable cooperation relationships with >30 leading domestic and global biopharmaceutical companies in the peptide fields.
From peptide to peptide plus
With Solid/liquid phase preparation and hybrid technology, Asymchem can provide development and manufacturing service ranging from tox batch to validation production for NDA filing including:
● Linear and cyclic peptide with 5 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 and other treatment areas.
In addition to traditional peptide drugs, we also have extensive experience in process development, analysis development, and GMP production for MMAE / MMAF and Drug Linker, peptide-drug conjugates, polymer, drug conjugates and other highly active peptide molecule.
Equipped with Qtof, UPLC-MS, UPLC, GPC and other analytical instruments, our analytical team can provide structure characterization, analytical method development and validation, IPC support, final product release testing, stability study according to ICH requirement. In addition, our team could provide document preparation service to support IND /NDA filing.
Integrated Platform for Chemical Macromolecule CMC Service
● Integrated experienced team: process, analytical, manufacturing, QC and QA
● Well equipped facilities
● Integrated service scope: peptide, drug linker, oligonucleotides and the conjugates between them
Reliable and qualified supplier chain management system including self-made synthetic capability of key materials and intermediates
● Strong support from GMP and EHS compliance
Client-Centric Mode and Personal Service
● Project management system and dedicated project team
● Responsiveness to change in project needs
● Shorter lead time
Competitive Cost and High Quality