From laboratory scale to GMP manufacturing

As a strategic business platform, our chemical-macromolecule team includes more than 100 experienced R&D and analytical professionals and is supported by four manufacturing sites.

Our peptide technology platforms cover solid-phase and liquid-phase synthesis, chromatographic separation, membrane concentration and purification, lyophilization, and spray drying. Continuous-reaction and biotransformation technologies support the supply of complex, high-quality non-natural amino-acid building blocks. QbD-based process and analytical development and scale-down-model process transfer support validation manufacturing and NDA submissions.

Service scope: peptides and Peptide-Plus

Using solid-phase, liquid-phase, and combined synthesis technologies, we provide R&D, analytical, and gram-to-tens-of-kilograms manufacturing services for linear peptides containing 5 to 40 amino acids, cyclic peptides, modified natural peptides, disulfide-containing peptides, stapled peptides, and thioether peptides. Programs can progress from toxicology batches through NDA validation manufacturing and cover therapeutic areas including GLP-1, antiviral, antimicrobial, oncology, and age-related macular degeneration.

Beyond traditional peptide therapeutics, we have experience in process development, analytical development, and GMP manufacturing for highly active peptide-related molecules, including drug linkers containing peptide linkers and MMAE, MMAF, or related analogues, peptide-drug conjugates, and polymer-drug conjugates.

Analytical capabilities including QTOF, UPLC-MS, UPLC, and GPC support structural characterization, analytical-method development and validation, in-process control and final-product release for GMP manufacturing, ICH-compliant stability studies, IND and NDA documentation, and CTD writing services.